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					Newsletter June 2009
                                        AUSTRALASIAN             LEUKAEMIA           AND      LYMPHOMA               GROUP
                                      AUSTRALASIAN LEUKAEMIA AND LYMPHOMA GROUP




                                                                                                                      Number 26

Translational research - the Roberts Revival
Roberts Revival                                                   PCNS
The Laboratory Science Committee                                  Samar Issa is working diligently on a PCNS trial proposal (page 8). Incor-
lead by Joy Ho and Andrew Roberts                                 porated into this trial will be a lab study involving gene expression profil-
                                                                  ing. Maher Gandhi aims to identify a biomarker that correlates with prog-
conducts comprehensive review of
                                                                  nosis of PCNS lymphoma.
laboratory proposals at both the
May and November ALLG meetings.                                   HD8 RATHL
Subsequently the full membership                                  Judith Trotman and Leanne Berkahn have worked with Maher to establish
receives regular updates within the                               a lab study attached to the HD8 trial to investigate whether there is a
context of the main meeting agenda.                               relationship between PET positivity and effect of EBV+/-. Maher hypothe-
                                                                  sises that biomarkers can be used to identify risk groups and monitor
Joy is currently on sabbatical in the                             tumour load in Hodgkin Lymphoma. The data can supplement interim PET/
USA so chairing the May meeting                                   CT to generate new treatment algorithms for response adapted therapy.
was left to Andrew …with such a                                   The study would only be on the Australasian component of the interna-
fully packed agenda it could be                                   tional trial (100 patients over 4years), and would enable prospective data
termed nothing other than a Lab       Andrew Roberts -            on 100 advanced HL cases with full clinical annotation (including interim
                                      Revivalist!!!               PET), all treated with uniform therapy up to the time of the lab studies
Science Roberts Revival!                                          primary endpoint (which is the interim PET result).
AML follow on proposals.
                                                                  Multiple Myeloma MM12
Analysis of Paula Marlton’s initial 50 AMLM13 samples indi-       Leopard Study
cates that Wt1 is a useful indicator of relapse and should        Andrew Spencer proposes a full
be incorporated into molecular risk profile in future stud-       compliment of laboratory proposals
ies. The presence of Wt-1 mutations is a strong independ-         within the next myeloma trial. Ob-
ent risk factor of poor outcome due to resistance, relapse        jectives include
and death in CN AML (NK AML). Wt-1, which encodes                 1. Quantify MRD by serum FLC
transcription factor, is located on 11p in the N- terminal        assay, HevyLite assay (HL) and multi-
transcription regulatory domain and C-terminal Zn finger          parameter flow cytometry (MFC) in
                                                                  patients with IF- CR and correlate
domain. Wt1 functions to activate or suppress gene tran-
                                                                  (where applicable) with AS0-PCR.
scription , is a tumour suppressor in WAGR syndrome and
is mutated in Wilms tumour, Denys Drach and Frasier syn-          2. Evaluate kinetics of response and
                                                                  loss of response and correlate with         Inside this issue:
dromes. The precise role of Wt1 in haemopoiesis and AML
                                                                  clinical outcomes.
is controversial. The different isoforms, post translational
modifications, and tissue specificity of downstream targets       3. Prospectively evaluate T-cell im-
                                                                                                              MEETING HIGHLIGHTS      2
                                                                  mune reconstitution, T-cell clonality
indicates that Wt1 has complex functional roles.                  and T-reg populations post-ASCT.
The committee is considering proposals involving MRD by                                                       TRIAL NEWS              8
flow. Andrew Wei suggests new trials could include the
following types of samples: stroma collect and cryopre-
serve, germline DNA, and plasma. To better inform mo-                                                         SDMC, REGGIONAL         6
lecular stratification desirable tests would include: Flt3 mu-                                                PROGRAM
tational status, NPM, CEBPA, ERG, BAALC. Most problem-
atic is access to assays and also costs. Ken Bradstock re-                                                    MEMBERS                 14
ports that overseas laboratories are performing Signature
Based Stratification from Tissue Micro Arrays. Current             Target epitopes (in black) for
                                                                                                              TISSUE BANK             18
limitations in Australia are likely to be the cost of TMA.         Hevy-Lite antibodies are on the
The LSC aims to further develop these concepts in AML              constant regions (CH1 and CL)
                                                                   between the heavy and light chains
later in 2009 with a separate LS and AML trials meeting.           of immunoglobulin molecules.               TRAINING                22
                                                                   Research into HevyLite is an excit-
                                                                   ing area of research, particularly as
  SEE PAGES 2 to 4 FOR HIGHLIGHTS OF                               it may possibly be better than             NEWS AND VIEWS          26
          THE MAY MEETING                                          Immunofixation methods.
                            Newsletter June 2009

                            May 2009 Meeting highlights

                            Acute Leukaemia/MDS
                            With the imminent target accruals being reached in AMLM12, AMLM13 and APML4, possibilities for follow-on
                            proposals were discussed by Ken Bradstock, Paula Marlton and Harry Iland. To allow more in-depth discus-
                            sion and development of ideas for presentation at the November meeting, the AML sub-committee co-
                            chaired by Andrew Wei and John Seymour will initiate a full day workshop later this year to map-out the next
                            generation of Australian AML trials. Notification will be made via the ALLG. Watch this space!
                            MDS3 trial has rocketed through accrual and since the meeting in May it has reached the target of 80 patients
                            and closed to accrual. Hot on its heals is Melita’s new MDS proposal 7d aza to be given over max 9d (to avoid
                            weekend dosing). Lenalidomide will be introduced at cycle 3 to minimise early myelosuppression. There was
   Andrew Wei, Co
                            broad support for the further development of this MDS proposal - schema below:
   Chair Acute Leukae-
   mia/MDS Disease
   Group




      All presentations

      given at the

      meeting can be

      accessed from the

      ALLG website.

      Please note that

      these are for your
                            CML/MPD
                            In recent years it has become evident that imatinib is actively transported into the leukaemic cell via organic
      use, but must not
                            cation transporter-1 (OCT1). Tim Hughes and Deb White’s laboratory in Adelaide have been at the forefront
                            of research in this field, demonstrating that OCT1 activity is predictive of response to imatinib in CML. Ana-
      be passed on.
                            lysing CML patients on imatinib 600mg daily from the ALLG CML6 trial, they found that 55% of those with
                            low OCT1 activity had a complete cytogenetic response by 12 months compared with 92% of patients with
                            high OCT1 activity. The difference between rates of major molecular response at 18 months was equally
                            striking (17 vs 82%).
                            Other inter-individual differences also seem to play a role. Following the observation that imatinib plasma
                            levels are also predictive of outcome, the current ALLG CML9 study is investigating whether imatinib dose
                            escalation improves outcome in patients with low imatinib trough levels. Clearly, variations in pharmacokinet-
                            ics and drug transport are emerging as potential reasons for suboptimal outcome in CML. This raises the
                            possibility of optimising treatment based on measurement of OCT1 activity, imatinib trough levels, or other
                            laboratory measures predictive of outcome
                            At the May 2009 ALLG meeting, Tim Hughes proposed that the next ALLG CML study could examine
                            whether selecting therapy based on OCT1 activity improves outcome. Given that patients with high OCT1
                            activity appear to do well on imatinib, it would be appropriate for this arm to receive this drug, while the low
                            OCT1 activity arm may progress directly to a second generation tyrosine kinase inhibitor, such as nilotinib or
                            dasatinib.
                            There was also interest at this session whether we ought to be avoiding drugs known to inhibit OCT1, such
                            as prazosin, in patients with CML, as well as discussion about the optimal dose of imatinib.
Tony Mills, Co Chair CML/
MPD Disease Group




                            Page 2
Number 26

Supportive Care
A new prospective web-based psychosocial intervention study is aimed at improving psychological distress
and quality of life among adults undergoing treatment for haematological cancer. The study entitled “A RCT
of a web-based psychosocial intervention” will compare those allocated to usual care with those allocated to
the intervention group and will measure outcome parameters at 3, 6, 9 and 12 months after baseline. This
study was submitted to the NHRMC for funding by Professor Rob Sanson-Fisher’s team from Newcastle.
The SCO1 Aspid Trial has closed to accrual at 240 patients, which was the defined first interim analysis point.
Reasons for closing were slower than expected recruitment, funding and review of sample size.



Low grade NHL/MM/CLL
                                                                                                                      Pauline Warburton,
New proposals dominated this session and the following is a summary .                                                 Co Chair Low grade
The MM12 study, a phase II study of Lenalidomide and prednisone for post-ASCT maintenance therapy in                  NHL/CLL/MM Dis-
patients with MM incorporating minimal residual disease (MRD) monitoring, is now well developed. It will              ease Group
target a similar population as the MM6 trial. MRD will be monitored using the Freelite serum FLC assay, the
new Hevylite assay, multiparameter flow cytometry and ASO-PCR. The majority of the discussion focused
on VTE prophylaxis with general consensus supporting the use of aspirin in those with no or low risk factors,
and LMWH in those with a history of VTE. Correlative laboratory studies of the hypercoagulable state asso-
ciated with the use of Lenalidomide are being considered.
The proposed CLL6 trial is a phase III, randomised trial comparing fludarabine, cyclophosphamide and rituxi-
mab (FCR) with or without Lenalidomide consolidation in CLL. Only patients with MRD at the end of induc-
tion would be randomised to consolidation therapy. Use of oral versus iv fludarabine generated discussion
and the outcome is that use of either is at centre choice. Generally clinicians supported the idea that patients
who are MRD negative after 3 cycles of FCR do not need further FCR cycles, but to be randomised to Le-
                                                                                                                        All presentations
nalidomide maintenance, patients must have received at least 4 cycles of FCR. There were some concerns
with the ability to achieve recruitment numbers, however experience so far with CLL5 indicates target ac-               given at the
crual may be achievable.
The European Myeloma Network proposes a new trial in previously untreated systemic AL amyloidosis.                      meeting can be
Patients not eligible for ASCT will be randomised to either Melphalan and Dexamethasone or bortezomib,
Melphalan and Dexamethasone. Negotiations are ongoing but the trial is likely to be limited 30 patients at 5            accessed from the
sites in Australia. Pomalidomide, an IMiD, is demonstrating some promise in myeloma and myelofibrosis (as
presented at ASH 2008) with less myelosuppression than Lenalidomide. There was some discussion about                    ALLG website.
developing a proposal for trialling its use in AL amyloidosis.                                                          Please note that

Bone Marrow Transplant                                                                                                  these are for your
Flying solo….BM07 was the only active trial to report on but there’s good news as this trial is running well.           use, but must not
There are 18 patients accrued, 40 screened, 15 SAE (none zoledronic acid related).
The Royal Melbourne Hospital is actively accruing and at Westmead, Wellington, Christchurch, Auckland and               be passed on.
the Alfred the trial is going through ethics procedures. Royal Adelaide, Royal Brisbane are also considering
submitting the trial.
The SDMC approved an amendment (protocol Version 8.3) which encompassed:
• Least significant DXA scan value increased from 3 to 5%.
• Creatinine monitoring superseded by eGFR.
• Vitamin D management optimised and clarified
• Dental exclusion period pre study increased.

Intermediate & high grade NHL and Hodgkin lymphoma
Devinder Gill provided an update of international ACT-trials (Alemtuzumab and CHOP in T-cell lymphomas)
on behalf of Dennis Carney. There have been two recent protocol amendments to improve EBV monitoring,
and reduce the risk of CMV recrudescence. Accrual is slow but is about to accelerate since all original Euro-
pean sites are on board. The PI, Francesco D’Amore, is still keen for the ALLG to participate. However,
there is likely to be a Lenalidomide study available in this group of patients in the near future as well.
The HOVON randomised phase III trial of Ofatumumab versus Rituximab followed by ASCT in relapsed or
refractory DLBCL received little interest amongst the group and there is little opportunity to have input into
the protocol at this stage.
NEW STUDY OPEN: Siew Koh launched the ALLG HD9, a cross-sectional survey aimed at medical specialists              Devinder Gill, Co Chair
and nurses across Australia/NZ treating HL patients and managing long-term survivors. The on-line survey has       Aggressive NHL/HL Disease
44 questions and takes only 15 minutes to complete. Please contribute to this valuable research.                   Group


                                                                              Page 3
                                         Newsletter June 2009


                              May Meeting photo gallery




                Ray has
                sprouted
                wings - is
                he about
                to fly…??




Data Managers Events
Data managers day - Wednesday 6 May
We started with a full morning agenda of trial review:
• MDS3 and SCO1 Ania Matera reported on these two studies
   which have since closed
• NHL21 Cattram Nguyen guided us through start up procedures
   for this newly opened trial
• CLL5 Sarah McInnes describing great progress in recent months
• CML8 Ruth Columbus reporting cohort reopening
• CML9 Bereha Khodr urging participation and appealing for tissue
    bank samples PLEASE!!.
The group was fortunate to hear again from Megan Ellis updating
with the holdings figures demonstrating the great work of the ALLG
Tissue Bank. In the afternoon, Megan Sanders, the newly appointed
ALLG Protocol Development Coordinator, introduced her new
role and outlined the direction of the ALLG regarding future trial
development. Megan has strong working history in laboratory sci-
ence and trial preparation in industry. Megan’s main focus will be to
assist ALLG clinicians to produce a trial concept and progress to
clinical trial protocol that encompasses all facets important to
ALLG research such as laboratory science and tissue banking.
Rosie Hoyt entertained us with some fabulous photographs of her visit to ASH at San Francisco. Rosie provided a comprehensive overview of ses-
sions attended, with an update of the IRIS study and the STIM trial. Rosie attended sessions specific to APML, reporting to the DM’s the novel future
strategies of use of oral arsenic and new retinoid ‘Tamibarotene’. Thank you Rosie!
David Ridler, ALLG Business Manager, updated everyone with the COSA CTRA which will now be used as the site agreement with all ALLG trials in
Victorian and NSW. Please contact him if you have any issues with the agreement.
I would personally like to thank: Alvin Milner, Megan Ellis, Leanne Berkahn, David Ridler, Marina Dzhelali, Anais LeGall, Marianne Hundling, and Sarah
McInnes for their expert contributions as panel members to the Hypothetical “Conundrums faced in the conduct of ALLG LB2 Trial of relapsed Lym-
phoma of the Big Toe. Randomised trial of chemotherapy plus exercise at home vs. chemotherapy plus exercise in a gym”. Lets hope ALLG Tissue
Bank will never have to process and store toe nail clippings for future research!!

                                                                                  Above: How many glasses does it take to keep two Victorian trial
                                                                                  coordinators hydrated?????
                                         Page 4
                                        Newsletter June 2009

Haematology educational – NHL (Tuesday 5 May)
Thanks to the enormous efforts of our five presenters, the ALLG provided a comprehensive Education Day to our
Data Mangers & Research Nurses. The vast topic of NHL was covered in a condensed but comprehensive program.
Victoria Potter provided the ground work, focusing on haemopoiesis, lymphoma development, and clarification of the
histology and classification. The 7th most common cancer worldwide, NHL being a malignant disease of lymphocytes
may be derived from either B- or T-cells and can be indolent (slow growing, low grade) or aggressive (fast growing,
high grade) in nature. NHL patients may have immune deficiency but most have no risk factors; their lymph nodes
and other body sites can be affected, while symptoms are quite variable depending on the sites involved and the ex-
tent of their disease.
The different types of NHL are classified according to histopathological, immunological, and molecular characteristics
as delineated within the recently revised WHO classification system. Follicular lymphoma is the most common form
of Indolent NHL and cannot be cured but remission is achievable. DLBCL is the most common form of aggressive
NHL and must be treated immediately. Transformation of indolent to aggressive NHL is common.
Waldeyer’s Ring: an interrupted circle of protective lymphoid tissue at the upper ends of the respiratory and alimen-
tary tracts. Thanks to Pauline Warburton we will not dare forget the definition of Waldeyer’s Ring!
Craig Wallington your time starts NOW! in record timing Craig gave the best and most comprehensive overview of
the RARE lymphomas. MCL, PTCL and the starry sky Burkitt. Stephen Larsen’s schema ‘A practical way to think of
lymphoma’ I’m sure will be posted to most desk notice boards. Also of value is Stephens’s circular diagram which
simply explains the treatment options FCL.
                                                                                         The afternoon was facili-
                                                                                                                             Victoria Potter and
                                                                                         tated by Mark Hertzberg,            Craig Wallington
                                                                                         first describing the treat-         presented at the
                                                                                         ment options for aggressive         educational

                                  AutoSCT / AlloNMT
                                                                                          lymphoma including his personal preference for fried
                                                                                          rice (not short of a joke to keep us all awake). Mark
                     Watchful                           Chlorambucil or
                     waiting                                 CVP                          discussed the role of novel agents such as the pro-
                                                                                          teosome inhibitors which are showing activity in the
                                                                                          treatment of MCL, the new radio-immunotherapy
                                                                                          agent ‘’Zevalin’ in the context of current ALLG NHL21
                                      Treatment
               MabThera                                       CHOP                        trial.
                                      modalities
                                                                                          Great thanks must be given to Roche for their kind and
                  RadioIT                                                                 ongoing support to the ALLG to conduct haematology
                                                                                          education, and special thanks to Mark, Pauline, Victoria,
                                                        Fludarabine
                     CHOP +                                                               Craig and Stephen for their outstanding presentations.
                    MabThera
                                    Fludarabine
                                +Cyclo / Mitoxantrone
                                     ± Mabthera



             A practical way to think of lymphoma                                                                  The NHL resource
                Category                   Survival of        Curability        To treat or
                                           untreated                            not to treat                       manual contains all
                                            patients
                                                                                                                   presentations plus
     Non-               Indolent          Years              Generally         Generally
     Hodgkin                                                 not curable       defer Rx if                         other useful
     lymphoma                                                                  asymptomatic
                        Aggressive        Months             Curable in        Treat                               material. It can be
                                                             some
                                                                                                                   accessed from the
                        Very              Weeks              Curable in        Treat
                        aggressive                           some                                                  ALLG website.

     Hodgkin            All types         Variable –         Curable in        Treat
     lymphoma                             months to          most
                                          years



                                        Page 5
                 Newsletter June 2009

We would like to thank the below sponsors of the ALLG Scientific Meeting, held in Sydney in May.

Only companies which sponsor the meetings may attend sessions. For any further information re-
                      garding sponsorship please contact Dilu Uduwela



                             Gold Sponsors




                               Silver Sponsors




                                  Bronze Sponsors




                 Page 6
                   Newsletter June 2009

                   CLL Australian Research Consortium
                   (CLLARC)
                   The Chronic Lymphocytic Leukaemia Australian            The ALLG has had a close association with CLLARC
                   Research Consortium (CLLARC) is a non-profit            since its inception, particularly in relation to trial
                   organisation which was established to advance the       development and conduct. ARC has its own website
                   understanding of and research into CLL. The organi-     with information available about its activities and also
                   sation is dedicated to improving the outcomes of        educational information for patients about CLL.
                   patients with CLL and progress towards the control
                   and cure of the disease.

                   The aims of the CLLARC include :                               Visit the CLLARC
                   •   Develop and conduct CLL Clinical Trials in Aus-                 Website!
                       tralia.
                                                                                 http://www.cllarc.org/
                   •   Foster research and scientific collaboration and
                       support for CLL projects in Australia.


                   Memo of understanding - CLLARC and ALLG
                   The CLLARC group held its second meeting for this year at the ALLG Scientific meeting on Wed afternoon.
                   The ALLG and CLLARC are both working closely together to establish a clear and useful MOU for the devel-
                   opment and implementation of clinical trials.
                   ALLG CLLARC trial collaboration - PIs David Gottlieb and Con Tam
Any clinician      ALLG CLL6: An Australasian, Phase III, Multicentre, Randomised Trial Comparing First-Line Fludarabine,
                   Cyclophosphamide and Rituximab (FCR) Chemotherapy With or Without Lenalidomide Consolidation in
interested in      Physically Fit Patients with Chronic Lymphocytic Leukaemia
                   Background to trial proposal:
finding out more
                   FCR chemotherapy permits the majority of previously untreated patients with CLL to achieve a clinical com-
about CLLARC       plete remission. Using non-stringent flow-cytometric methods, around 30% of patients have evidence of re-
                   sidual disease after completing treatment and these patients have a shorter time to disease progression and
should contact     shortened overall survival than those with undetectable disease. More stringent criteria recently developed
                   for the analysis of residual CLL are likely to double the number with measurable residual disease remaining
Stephen            after FCR chemotherapy. Data from the CLL8 German study shows that the level of minimal residual disease
                   (MRD) achieved during and after FCR chemotherapy is the major determinant of progression free survival.
Mulligan or Sue
                   This proposal will assess the capacity of Lenalidomide to convert residual disease after chemotherapy to an
Tremlett           MRD- state. The relationship between depth of remission and disease outcomes will be determined by corre-
                   lating MRD status, remission duration and overall survival.
                   Study Design:
                   This is a randomised trial of Lenalidomide given following FCR chemotherapy for previously untreated CLL.
                   Patients with previously untreated CLL requiring treatment (based on standard criteria) will receive induction
                   chemotherapy with FCR, either oral or intravenous depending on centre choice. Patients with measurable
                   residual disease after FCR will be eligible for randomisation to consolidation with Lenalidomide or no further
                   therapy. All patients are planned to receive 6 cycles of FCR but patients are permitted to cease FCR after at
                   least 3 cycles, and proceed to the consolidation phase, under the following circumstances: attainment of mor-
                   phological complete remission, chemotherapy intolerance or occurrence of a major adverse event, and/or
                   patient’s decision to decline further chemotherapy. Assessment for evidence for clinical and minimal residual
                   disease (MRD) will occur after completion of FCR, and prior to consolidation phase; those with evidence of
                   residual leukaemia will be randomised to observation or Lenalidomide treatment for a total of 2 years. Ran-
                   domised patients will be monitored for evidence of disease progression using clinical, radiological and flow
                   cytometry according to standardised international criteria.
                   The aim is to register 320 patients with a target to randomize 192 to the Lenalidomide v no Lenalidomide
                    Page 7                                arms. The Protocol is near completion, and is planned for SDMC review
                                                          this July.
                           Newsletter June 2009


                           Trial News

                           Trials in development

                           NHL24 PI: Samar Issa
                           Upfront treatment methotrexate 3 mg/m2 with randomisation to teniposide BCNU
                           Prednisone or T BCNU P plus rituximab in primary CNS lymphoma
                           Inclusion will be patients with a histologically confirmed diagnosis of CD20 positive DLBCL based upon a
 NHL24                     representative histology specimen of a brain biopsy according to the WHO/ECOG classification OR patients
 Principal Investigator    with a diagnosis of evidence of brain parenchymal lesion showing homogeneous contrast enhancement sus-
 Samar Issa                pect for lymphoma AND unequivocal morphological and/or immunophenotypic evidence of CSF lymphoma
                           OR unequivocal morphological and/or immunophenotypical evidence of lymphoma in vitreous fluid. It is
                           hoped this trial will be conducted jointly by the ALLG and HOVON.



                           HD8 PI: Judith Trotman, Leanne Berkahn
                           A randomised Phase III study to assess response adapted therapy using PET in newly
                           diagnosed advanced Stage Hodgkin Lymphoma (RATHL trial)
                           International news: The RATHL is coordinated by the CR UK and UCL Cancer Trials Centre in the UK. The
                           coordinating office, previously the Lymphoma Trials Office, has been renamed the Haematology Trials Group,
                           due to the expansion of their portfolio to include myeloma and leukaemia trials.
                           The trial has now been open for 10 months in the UK. So far 36 patients have been registered with 18 of
                           these randomised. Currently 37 sites in the UK are active with more on the way. In Italy a number of sites
  HD8 PI
                           are also nearly ready to commence recruiting. For information about plans to commence the trial in Austra-
  Principal Investigator   lia/New Zealand see page 17.
  Judith Trotman


                           MM11 PI: Andrew Spencer
                           A Phase 3, Multicentre randomised controlled study to determine the efficacy and
                           safety of Cyclophosphamide, Lenalidomide and Dexamethasone (CRD) versus Mel-
                           phalan (200mg/m2) followed by Stem Cell Transplant in newly diagnosed Multiple
                           Myeloma subjects
                           Trial Manager: Nola Kennedy
                           The primary objective of this trial is efficacy of CRD vs high dose Melphalan. Secondary objectives are safety
                           of CRD vs high dose Melphalan, prognostic value of risk factors, safety & efficacy of R maintenance, prognos-
                           tic value of sCR by free light chain assay. The accrual target is 100 patients over a 2 year period with an ex-
                           pected 20 sites in Australia and NZ sites. The trial is well funded and the Revlimid is provided by Celgene.
  MM11                     Coordination will be via the Alfred Trial Centre so please contact Nola Kennedy (N.Kennedy@alfred.org.au)
  Principal Investigator   if you have questions.
  Andrew Spencer


                           Current trials

                           ALL5 PI: Andrew Grigg
                           A phase II pilot study of dasatinib combined with induction chemotherapy in de novo
                           Philadelphia chromosome-positive acute lymphoblastic leukaemia
                           Trial Manager: Glen Wiesner
                           This trial recently opened to accrual with 6 sites in Melbourne, Sydney and Adelaide currently active. No
                           patients have yet been registered. ALL5 includes patients aged 16-70 with Ph+ ALL. The primary objective is
                           to investigation of the safety and tolerability of dasatinib in combination with induction chemotherapy for Ph+
ALL5
                           ALL. The trial requires just 20 patients for target accrual, so please contact Glen
Principal Investigator
                           (Glen.wiesner@petermac.org) for information on site set up and trial management details.
Andrew Grigg

                           Page 8
Number 26


Featured trial

NHLLOW5 (TROG 99.03) PIs: Michael MacManus,
John Seymour
A randomised multicentre trial of involved field radiotherapy versus involved
field radiotherapy plus chemotherapy for stage I-II low grade follicular lym-                                           NHLLOW5 (TROG 99.03)
phoma                                                                                                                   Principal Investigator
                                                                                                                        Michael MacManus
Trial Manager: Bev McClure
This isn’t just a good study …… it is a great study and as a matter of fact it is still the ONLY
trial available in Stage I-II Follicular Lymphoma and is ONLY study of adjuvant Mabthera. The                           NHLLOW5 Accrual
Primary endpoint is progression-free survival with 87% power to detect improvement in 5-
year PFS from 60 to 75%. It is also powered to detect OS benefit of 15% at 10 years. Cen-                            Albury/MVP                    5
tral molecular monitoring and second malignancy data are incorporated. This trial is truly                           Auckland                      9
                                                                                                                     Canberra                      3
unique, it seeks to answer an important unresolved question and is already by far the biggest                        East Coast Cancer Centre 4
trial of its type ever conducted in this group of patients. Accrual has been slow, and cur-                          Geelong                     5
                                                                                                                     Launceston                  1
rently is 108 of the target 200. Thankyou to the great work at the following sites:                                  Mater Brisbane              1
John Seymour is exploring the possibility of an international collaboration with the UK. If this                     Mater Newcastle            14
                                                                                                                     Peter MacCallum            24
goes ahead a suggested name change is …. NHLLUK5 …..                                                                 Prince of Wales             1
                                                                                                                     Princess Alexandra          5
…..N.H…LUCKY 5 is a winner and here’s the real spinner, we know you’ve all seen it and                               Princess Margaret (Toronto)10
you surely don’t mean it, but when accruals real slow, with 92 rego's to go, the only way                            Queen Elizabeth             1
forward is to get on board-it, so don’t just sit their, get down to your clin yeah…..                                Royal Adelaide              9
                                                                                                                     Sir Charles Gairdner        5
Proudly brought to you by the ALLG Rap team - a new initiative of the ALLG Get Trials Re-                            Waikato                     1
                                                                                                                     Wellington                  2
cruited To Committee. (GTRTC)                                                                                        Westmead                      8



Closed trials - ladies lead the way!!
SC01 PIs: Orla Morrissey, Monica Slavin
Multicentre randomised controlled clinical trial comparing two strategies for the diag-
nosis of invasive aspergillosis in high-risk haematology patients (ASPID study)
Trial Manager: Ania Matera
As reported in the previous newsletter the SDMC recommended of the SDMC closure upon reaching the
accrual target previously set for the interim analysis. This trial was achieved on 12/5/2009 It is expected the
last patient with complete treatment in November 2009. The Outcome Review Committee (ORC) will con-
vene in coming months. Congratulations to all sites that contributed to the accrual of patients.

AMLM13 PIs: Paula Marlton, John Seymour, Andrew Grigg
High dose cytosine arabinoside & fludarabine without anthracycline for CBF AML
Trial Manager: Juliana Di Iulio
Congratulations to the PIs and all involved for a magnificent job. On the 20 June, the 53rd patient was regis-
tered and the trial closed to accrual. There were no safety concerns at any time and the trial truly lead the
way in MRD analysis. We eagerly await analysis reporting once all the patients complete treatment and data is
submitted. Please contact Juliana (Juliana.diulio@petermac.org) with any questions.
                                                                                                                          AMLM13
MDS3 PIs: Melita Kenealy, John Seymour                                                                                    Principal Investigator
A Phase I/II trial to determine safety and efficacy of combination therapy with 5-                                        Paula Marlton

azacitidine (Vidaza) and Thalidomide in patients with Myelodysplastic Syndromes
Trial Manager: Linda Cowan
 Can’t believe it?, neither can we, but thanks to the hard work of Melita, Linda and all the site staff this trial
has reached (in half the expected time) its target accrual of 80 patients. Closing on the 3 July 2009, this was
truly a terrific feat!

                                                                                 Page 9
                             Newsletter June 2009


Centre for Biostatistics and Clinical Trials (BACT)

BaCT News
                             e-Registration                                      nounced that she is returning to Korea to
                             BaCT are preparing to pilot a new web-              join the rest of her family.
                             based patient registration and randomisation        The appointment of Gaelle Dutu has taken
                             service for its clinical trials. The service will   some of the strain off our remaining staff but
                             provide site staff with the facility for patients   we continue to meet challenges. To assist
                             to be registered and randomised 24/7, thus          with the management process for statisti-
                             meeting the needs for urgent treatment and          cians, and to reflect the role which he has
                             overcoming frustrations and delays caused           taken on over recent months, Alan
                             by time differences between trial sites and         Herschtal has been promoted to a Senior
    BaCT programmer
                             BaCT. Previously it had been planned to             Statistician from the 1st July.
    Linas Silva
                             develop a generic system. However it has
                                                                                 An Australian statistician who has recently
                             now been decided that the system will be
                                                                                 completed PhD at the Clinical Trial Service
                             provided by a selected vendor on a per trial
                                                                                 Unit at Oxford University has accepted an
                             basis, as this has proved more cost efficient.      offer to join BaCT and is expected to start
                             After the system is piloted, it will become         in late November.
                             available for ALLG trials as appropriate.
                                                                                 In addition Ditas Sioco, the new clinical trials
                             How this will work is currently under dis-
                                                                                 assistant, has provided valuable assistance
                             cussion – more news in later newsletters.           with the management of clinical trials par-
                             Staff changes                                       ticularly data entry.
                             In addition to Dr John Reynolds departure in
                             March this year, Dr Jimin Choi recently an-
   Senior Statistician
   Alan Herschtal




New BaCT staff
                         Gaelle Dutu is a new Biostatisti-         Ditas Sioco: Since March 2009,
                         cian in the Biostatistics and Clini-      BaCT has a new full-time Clinical
                         cal Trial Centre (BaCT). She has a
                                                                   Trial Assistant, .
                         Masters of Science in Statistics and
                         10 years experience as a statisti-        Ditas comes to us with 14 years'
                         cian, including four specifically in      experience as a data entry special-
                         Biostatistics.                            ist. Ditas is a quiet achiever, and
                         Gaelle worked previously in New           highly organised. This targeted in-
                         Zealand at the Auckland Univer-           jection of fresh resources has nota-
                         sity, on various projects in head         bly picked up the pace of data en-
                         and neck cancer, breast cancer            try, especially for CML9 and MDS3.
  New statistician:      and palliative care. She also                                                     New clinical
                                                                   A warm welcome, Ditas!
  Gaelle Dutu            worked in mental Health, on clas-                                                 trial assistant
                                                                                                           Ditas Sioco
                         sification of mental Health disor-
                         ders and bipolar disorder using
                         outcome measures.



                             Page 10
Number 26

Want more information about a trial?
These trial managers are responsible for the overall management of each trial. Please contact them with any trial specific queries.

Trial                Status         Trial Manager          Location                   Email                              Phone No
ALL5                 Open           Glen Wiesner           BaCT                       Glen.Wiesner@petermac.org          03-9656 1878
AMLM12               Open           Juliana Di Iulio       BaCT                       Juliana.DiIulio@petermac.org       03-9656 3786
AMLM13               Follow-up      Juliana Di Iulio       BaCT                       Juliana.DiIulio@petermac.org       03-9656 3786
AMLM14               In devt        Narmatha Kuru          BaCT                       Narmatha.Kuru@petermac.org         03-9656 5807
APML4                Open           Juliana Di Iulio       BaCT                       Juliana.DiIulio@petermac.org       03-9656 3786
BM07                 Open           Glen Wiesner           BaCT                       Glen.Wiesner@petermac.org          03-9656 1878
CLL5                 Open           Sarah McInnes          BaCT                       Sarah.McInnes@petermac.org         03-9656 5801
CML6                 Follow up      Ruth Columbus          BaCT                       Ruth.Columbus@petermac.org         03-9656 1084
CML7                 Follow up      Ruth Columbus          BaCT                       Ruth.Columbus@petermac.org         03-9656 1084
CML8                 Open           Ruth Columbus          BaCT                       Ruth.Columbus@petermac.org         03-9656 1084
CML9                 Open           Bereha Khodr           BaCT                       Bereha.Khodr@petermac.org          03-9656 5802
CMLALL1              Closed         Sarah McInnes          BaCT                       Sarah.McInnes@petermac.org         03-9656 5801
HDNHL4               Follow up      Poppy Kypreos          BaCT                       Poppy.Kypreos@petermac.org         03-9656 1268
HD03                 Analysis       Poppy Kypreos          BaCT                       Poppy.Kypreos@petermac.org         03-9656 1268
HD04                 Open           Poppy Kypreos          BaCT                       Poppy.Kypreos@petermac.org         03-9656 1268
LY03                 Open           Poppy Kypreos          BaCT                       Poppy.Kypreos@petermac.org         03-9656 1268
MDS3                 Follow up      Linda Cowan            BaCT                       Linda.Cowan@petermac.org           03-9656 3637
MM6                  Follow up      Nola Kennedy           Alfred Hospital            N.Kennedy@alfred.org.au            03-9276 2217
MM8                  Open           Elaine Beller          Qld Clinical Trials Unit   E.beller@sph.uq.edu.au             07-3240 6693
MM9                  Closed         Nola Kennedy           Alfred Hospital            N.Kennedy@alfred.org.au            03-9276 2217
NHL16                Follow up      Sarah McInnes          BaCT                       Sarah.McInnes@petermac.org         03-9656 5801
NHL13 CORAL          Follow up      Poppy Kypreos          BaCT                       Poppy.Kypreos@petermac.org         03-9656 1268
NHL14 W&W            Follow-up      Poppy Kypreos          BaCT                       Poppy.Kypreos@petermac.org         03-9656 1268
NHL18                Follow up      Poppy Kypreos          BaCT                       Poppy.Kypreos@petermac.org         03-9656 1268
NHL19                On-going       Cattram Nguyen         BaCT                       Cattram.Nguyen@petermac.org        03-9656 5827
(MINT F/U)
NHL21                Open           Cattram Nguyen         BaCT                       Cattram.Nguyen@petermac.org        03-9656 5827
PT1                  Open           Cattram Nguyen         BaCT                       Cattram.Nguyen@petermac.org        03-9656 5827
SCO1 ASPID           Follow-up      Ania Matera            BaCT                       Ania.Matera@petermac.org           03-9656 3661



Interim statistician arrangements
Following the departure of Dr John Reynolds there are interim arrangements to provide on-going support to ALLG trials. Please contact the
allocated Clinical Trial Co-ordinator the first instance or otherwise statisticians as follows:
Alvin Milner (Alvin.Milner@petermac.org): AMLM12, MDS3, AMLM13, CML8, NHL11, HDNHL4, ALL6, ALL5, CLL6
Alan Herschtal (Alan.Herschtal@petermac.org): CML9, SC01, BM07
Richard Fisher (Richard.Fisher@petermac.org): APML4
Gaelle Dutu (Gaelle.Dutu@petermac.org): HD03
The allocated Statistician may change in the coming months once new Statisticians have been employed. For any difficulties or trials not listed
contact one of the following:
BaCT Clinical Trial Program Manager, Marianne Hundling: Marianne.Hundling@petermac.org
BaCT Acting Manager Statistics & IT, Alvin Milner: Alvin.Milner@petermac.org

                                                                          Page 11
                             Newsletter June 2009


                            The must-have publication of 2009!
                            Find out what everyone is raving about!

                            2008 marked the 35 year milestone for the organisa-       also current trial activity, a complete listing of publi-
                            tion and to commemorate this the ALLG Annual              cations by year and a nifty CD for all digital buffs (Jeff
                            Research Report 2008 features a double page photo         this means you!)
                            spread.
                                                                                      The Annual Research Report 2008 is available for
                            There are also reports from all areas of the group,       download in pdf or for a hard copy please contact
                            including the Executive ,Operations and Business and      Delaine Smith




                            Safety and Data Monitoring Committee
                            SDMC Membership                                           Andrew is Deputy Director of Clinical Haematology
                            There have been a number of changes in the mem-           and Bone Marrow Transplant at the Royal Melbourne
                            bership of the SDMC. As usual it’s an all-star cast,      Hospital. In 2007-2008 he was awarded the Robert
                            now featuring:                                            Pitney Travelling Fellow (Lecturer). Andrew as an
                            ALLG                                                      active researcher was instrumental in the establish-
                               Ray Lowenthal (Chair)                                  ment of a Haematology Translational Research Labo-
                               Peter Browett                                          ratory at the RMH. Andrew will be well known to all
                               Andrew Grigg                                           ALLG members, and has been active in the group
BaCT Senior Biostatisti-       Devinder Gill (ALLG Executive Liaison)                 over many years, having previously held leadership
cian Alvin Milner           External                                                  positions in the predecessor leukaemia group and
                               Patrick Kelly (Biostatistician)                        been PI for many trials.
                               Martin Stockler (Medical)                              With the departure of John Reynolds, Alvin Milner
                               John Stubbs (Consumer Representative)                  has taken over as the BaCT representative on the
                            Alvin Milner BaCT Statistician (non-voting)               committee.
                                                                                      April Teleconference
                            The ALLG Exec and SDMC thank Dr Judy Simpson              The teleconference approved the MM11 trial of
                            for her participation on the committee for the past 6     Cyclophosphamide, Lenalidomide and Dexa-
                            years. The SDMC welcomes Dr Patrick Kelly into            methasone vs Melphalan followed by Stem Cell
                            the role. Patrick has a Bachelor of Mathematics and a     Transplant in newly diagnosed Multiple Myeloma. The
                            PhD and more recently a Postgraduate Certificate in       committee also considered the HD8 RATHL study
                            Academic Practice. Patrick is the Senior Lecturer at      and will make a decision at the next meeting based
Patrick Kelly, University
                            the School of Public Health University of Sydney. He      on further information from the PIs.
of Sydney
                            worked previously at the Statistics Research Unit at
                            the University of Reading UK, specializing in the
                            development, teaching and application of new statisti-
                            cal methods for the design and analysis of clinical
                            trials. Patrick has published widely in well known
                            journal such as Statistics in Medicine, Journal of Bio-
                            pharmaceutical Statistics and the American Statisti-
                            cian.
                            At the last meeting it was evident that there was a
                            need to increase the ALLG representation in the
                            SDMC. A/Prof Andrew Grigg has accepted this new
                            position.
                                                                                                 Ray Lowenthal and
Andrew Grigg, Royal
                                                                                                 Delaine Smith
Melbourne                    Page 12
Number 26

Grant updates

NHMRC enabling grants




In 2005, there was an important milestone in the ALLG’s history. The            The EOI for the main ALLG infrastructure was submitted on 29 May and
group was successful in obtaining its very first peer review grant for infra-   provided a report of achievements since receiving the grant, a case for
structure and non-trial specific activities. The NHMRC enabling grants          continuation of funding and our vision for the future. We are told that
(collaborative group infrastructure) was $790K over 5 years. In the fol-        NHMRC will appoint a panel to review the submissions and prepare
lowing year the group was also successful in obtaining an NHMRC grant           recommendations for Research Committee on the outcomes for individ-
to support the Tissue Bank. These grants were exceptionally important in        ual facilities. We have not been given a timetable.
underpinning the groups activities, and laid the basis for the substantial
                                                                                The vision for the future emphasised translational research, new technol-
development since then. This first funding provided a springboard for
                                                                                ogy and the promotion of scientifically important investigator initiated
other funding sources, with the result that the group has very satisfacto-
                                                                                trials developed by Australian investigators, independently from the phar-
rily reduced its reliance on industry sponsorship.
                                                                                maceutical industry priorities. We outlined the infrastructure and activi-
After an extended delay, and with the grants nearly at an end we have           ties needed to support this aim, including informatics, QA, training, re-
finally been notified that there will not be another open competitive           gional program and strategic partnerships.
round. Instead, we have been invited to submit an expression of interest
                                                                                The Tissue Bank is in a different category and its enabling grant renewal
in receiving further funding.
                                                                                options have not yet been received.



ALLG Regional Program




                                          Seed funding grants - additional VCA funding
                                          The seed funding program for data management                submissions.
                                          support for regional supports was initiated at the
                                                                                                      Mater Newcastle will be able to employ a new staff
                                          beginning of 2008 with funding from Cancer Australia
                                                                                                      member, with a view to increase the ALLG trial
                                          and the Victorian Cancer Agency. The three funded
      Wollongong Hospital                                                                             portfolio, improve participation in smaller trials,
                                          sites were Geelong Hospital and Border Medical
                                                                                                      improve screening procedures.
                                          Oncology (Albury/Murray Valley Private) and Gos-
                                          ford Hospital). With the successful outcome of the          Bendigo Hospital administration have has already
                                          latest VCA grant, we have been able to allocate fund-       shown its support by agreeing to provide the de-
                                          ing to the applicants who missed out from the first         partment with new premises for the research unit.
                                          round i.e. Wollongong, Mater Newcastle and                  The additional staff funded through the ALLG grant
                                          Bendigo.                                                    will allow a greater opportunity to be involved in
        Bendigo Hospital                                                                              some of the clinical trials that are less well remuner-
                                          Wollongong Hospital will now receive funding for an
                                                                                                      ated. Bendigo have recently joined Cancer Trials
                                          increase in the dedicated Haematology Clinical Trial
                                                                                                      Australia which will also enhance their trial choices.
                                          Co-ordinator position to 1.0 FTE, which is intended
                                          to lead to more haematology trials may increase             The ALLG is the only collaborative group with a
                                          their ability to compete for lead site status for ethics
                                                                                                     Page 13
   Mater Hospital Newcastle
                               Newsletter June 2009

                               ALLG Operations Office
                                                                 The ALLG Operations Unit is steadily increasing in capacity to support our
                                                                 members. With thanks to the Cancer Australia grant, the Ops Unit now
                                                                 incorporates 5 people undertaking a number of roles that enable us to
                                                                 meet our Sponsor obligations.
                                                                 As everyone must be aware, the ALLG is a clinical trial sponsor, and as such
                                                                 must adhere to the multitude of regulations, guidelines and statements that
                                                                 stipulate and describe trial sponsor responsibilities. It can be an exhausting
                                                                 job keeping up with new developments. For instance, there have been re-
                                                                 cent changes to the NHRMC statement, and I recommend in particular that
From two part-timers to five     members and site staff familiarise yourselves with the NHMRC Australian Health Ethics committee
people: From left to right       (AHEC) Position Statement May 2009.
Megan Sanders, Dilu Udu-
                                 The May Scientific meeting was a great success and I thank our Sponsors and all the Disease Group Chairs
wela, David Ridler, Delaine
                                 for their help. The ALLG is featuring GCP training for Clinicians at both the May and upcoming November
Smith, Janey Stone
                                 meeting. If you have not complete GCP training then please make the most of the opportunity that the
                                 ALLG can offer. The full day course is provided on the Wednesday before the main meeting commences,
                                             it is run by Nucleus Network and funding support is available via the ALLG Roche QA partner-
                                             ship program. Delaine Smith, Operations Manager




                                           Operations staff at play…..



                               New members second quarter 2009
                                              Dr. Zane Kaplan                          Monash Medical Centre
                                              Dr. Victoria Potter                      Westmead
                                              Dr. Daniel Thomas                        IMVS
                                              Dr. Nicole Verrills                      University of Newcastle
                                              Dr. Craig Wallington-Beddoe              Westmead
                                              Dr. Andrew Butler                        Christchurch


      For any mem-
      bership or
                               Membership subscriptions for 2009
      subscription             2009 Membership renewal deadline has passed! If
                                                                                              What happens if you fail to
                               you haven’t renewed your membership, it’s still not
      queries please           too late to re-instate your it for this year. Other-                   renew?
      contact Dilu             wise, you will be deemed to be an unfinancial mem-
                               ber of the ALLG.
      Uduwela                  A membership renewal application form can be              ⇒ Removal from the membership list
                               found on our website under ‘About Us’ page (http://       ⇒ Cannot attend the twice yearly meetings
                               www1.petermac.org/allg/NewSite/AboutUs/
                               about_us.asp)                                             ⇒ Cannot sit on any ALLG committee including the
                                                                                             Executive and the Safety and Data Monitoring
                               The subscription options as of 1/1/2009 are                   Committee
                                   1 Year      2009                    $60               ⇒ A rejoining fee equal to that of one years sub-
                                   3 Year      2009 - 2011             $170                  scription ($60) will be required if you do not
                                   5 Year      2009 - 2013             $270                  renew your membership within a calendar year
                               Take advantage of the discounted fees by renewing
                               your membership for 3 or 5 years ahead.                   ⇒ Restricted access to the ‘Members Only’ section
                               Note: Membership for the 2009 year applies from               of the ALLG website
                               the 1st of January to the 31st December Inclusive. If     ⇒ Other restrictions may be placed on unfinancial
                               you joined the ALLG prior to the 31st December
                                                                                             members at the discretion of the ALLG
                               2009, you are still required to renew your member-
                               ship for the 2010 calendar year.

                               Page 14
Number 26

The way we were….
This is our regular history corner. If you have an anecdote, some information or topic you would like to                                                     Do you have a
include - or better still contribute - just contact Janey Stone                                                                                              memory of the



D
                                                                                                                                                             group’s history
                 id you know….??
                                                                                                                                                             you would like
           The ALLG (and predecessor groups) has conducted in its history a total of 93 trials.                                                              to share with
This includes:                                                                                                                                               others? Send it
                                                                                                                                                             to us - we’d
•         21 trials in acute leukaemia
                                                                                                                                                             love to print it.
•         25 trials in aggressive NHL
•         9 trials in multiple myeloma
•         10 trials in CML
Between 1984 and 2009 the group accrued a total of 4655 patients to trials, 1709 in acute leu-
kaemia, 339 in chronic leukaemia, 890 in aggressive NHL and 470 in multiple myeloma.


    600                                                                                                                                       Number of patients
                                                                                                                                              accrued in 5 year
    500
                                                                                                                                              groups between 1984
    400                                                                                                                                       and 2008
                                                                                                                             Tot acute leuk
                                                                                                                             Tot leuk         (Note: Grouping 06-08 has only 3
    300
                                                                                                                             Tot NHL          years)
                                                                                                                             Tot lymph
    200                                                                                                                                       The approximate three-fold in-
                                                                                                                                              crease in accrual in the 1996-2000
    100                                                                                                                                       period over the previous period is
                                                                                                                                              clear to see.
      0
             84-85             86-90           91-95              96-00          01-05            06-08




                                             ALLG Trials - year opened                                                                        Number of ALLG tri-
                                                                                                                                              als opened per
    10
                                                                                                                                              year1992 to 2008
     9
     8
     7
     6                                                                                                                              Int
     5
     4                                                                                                                              ALLG
     3
     2
     1
     0
          1992
                 1993
                        1994
                               1995
                                      1996

                                             1997
                                                    1998

                                                           1999
                                                                   2000
                                                                          2001

                                                                                 2002
                                                                                        2003

                                                                                               2004
                                                                                                      2005

                                                                                                             2006
                                                                                                                    2007
                                                                                                                           2008




                                                                                                               Page 15
      Newsletter June 2009

      Executive news - arrivals and departures
                                                                     Unchanged:

                                                                     Leanne Berkahn, Mark Hertzberg, Devinder
                                                                     Gill, David Ridler (Business Manager), John
                                                                     Seymour. (Joy Ho is on sabbatical).




      Arrivals: Andrew Wei, Ian Lewis, Tony Mills.

The new boys on the block have a lot to live up to!!!




            Since the election of the new
            members, the Executive has been
            focusing on developing and clarifying their roles. A full list of responsibilities can be
            found on the back page. You will notice that there are now two Chairs for each Disease
            Group, some of whom are not members of the Executive. In addition there are a num-
            ber of new specified liaison roles including: Tissue Bank, CLLARC, pathology review, and
            Western Australia.


                             Departures: Chris Arthur, Peter Bardy, Andrew Spencer.
                             Peter and Andrew continue to contribute to the leadership of the group. Peter
                             remains as a Disease Group Chair in Supportive Care. Andrew remains on the Stra-
                             tegic Planning Steering Committee.
                             Thank you to all three for your contributions over the years.




       Pathology Review Committee
         The ALLG is making progress on re-establishing        reviews, timely retrieval and browsing speed, storage
         the PRC. The committee aims to develop a pathol-      capability. At the May meeting the PRC invited Ape-
         ogy data module within the ALLG that will enable      rio Systems to demonstrate their pathology solu-
         national diagnostic consultation of ALLG trial case   tions software. Aperio’s digital pathology demonstra-
         reviews. Integral is application of image analysis    tion showed great quality images, remote functional-
         software that is complementary to research use.       ity, and real-time reporting capability. The system
                                To implement the PRC needs     also allows for viewing, analysis and management in a
                                a system that encompasses      multi-site environment. Members of the PRC will be
                                scanned image of quality       looking into this further, if you are interested in
                                appropriate for lymphoma       becoming involved please contact David Ellis, John
                                and haematology remote         Seymour or Delaine Smith at the ALLG Office.

      Page 16
Number 26

Financial and strategic news
End of financial year has been a frantic one in the ALLG office, David has been busy with progressing with site
EOFY business. If you have any outstanding site business please contact David direct 03 9656 3656.




Site contracts and agreements
                                                                                                                     Business Manager David
The new comprehensive Clinical Trail Research                  ganisation should accept this agreement without       Ridler, Treasurer Mark
Agreement for use between cooperative research                 further review                                        Hertzberg

groups and hospital sites. NSW Department of
                                                           • Public health organisations still have the ability to
Health announced their policy in June that this agree-
                                                               negotiate specific additional operational terms and
ment is to be used in all NSW public hospitals for all
                                                               conditions for particular clinical trial agreements
cooperative group trials.
                                                               with the sponsoring collaborative or cooperative
                                                               research group, where required.

                                                           The ALLG trial centre data managers will be issuing
                                                           the new agreement as sites undertake ALLG trials.
The NSW policy includes the following two points:
                                                           For any questions regarding the CTRA please contact
• Where a collaborative or cooperative research
                                                           David Ridler at the ALLG Office.
   group uses the CRG Sponsored CTRA for a clini-
   cal trial without alteration the public health or-




Structural changes in the ALLG
The consultant firm SACS Consulting continue to assist with the de-
velopment of detailed plans and documents for structural changes.
which it is anticipated will include a review of the constitution and
establishment of a Board. The planning steering committee consists of
Andrew Spencer and Peter Bardy and David Ridler is over sighting this
process on behalf of the Executive.



                                                     “I’ll be happy to give you innovative think-
                                                                 ing - what are the guidelines?”




HD8 RATHL trial
The group submitted an NHMRC project grant to              that this is a good study with sound scien-
fund the RATHL trial in March. As everyone knows,          tific merit. The Executive approved seed
the NHMRC is not known for its speedy decision             funding, and the trial will now continue
making process, and the outcome won’t be known             development i.e. contracts and other trial
until nearly the end of the year.                          establishment requirements. Hopefully
                                                           there will be more news in the September
The Executive discussed the request from the trial
                                                           issue of the newsletter.
PIs Judith Trotman and Leanne Berkahn for seed
funding, to get the trial off the ground. It was agreed


                                                                                                                     HD8 RATHL trial
                                                                                                                     Principal Investigators
                                                                                                                     Judith Trotman (above),
                                                                                 Page 17                             Leanne Berkahn
                                           Newsletter June 2009

   PwC National Leukaemia and Lymphoma Tissue Bank
                                        Tissue bank consent forms                                     Tissue Bank. With the appointment of Megan Sanders
                                        All samples in the tissue bank must comply with in-           as the Protocol Development Coordinator and with
                                        formed patient consent. The has been a rethink of             the assistance of staff at the Tissue Bank, it will now
                                        strategy in relation to increase the number of trial          be possible to integrate detailed instructions into
                                        patients participating in tissue banking. This does not       protocols early and prospectively, to include tissue
                                        relate to samples being taken for trial specific pur-         banking consent with every protocol and to refine
                                        poses. Patients consent to their samples being used in        sample collection requirements.
                                        future unspecified ethically approved research. In the        Not all sites have staff that are familiar with sample
                                        past this has been mainly done via generic consent            collection. The Tissue Bank scientist and samples
                                        but in some cases via tissue banking consent that has         collection coordinators are available to liaise with
                                        been built into a trial protocol.                             clinical PIs as well as the Laboratory Science Com-
                                        The plan now is to include tissue banking consent in          mitte and research labs involved. They will also work
                                        all future ALLG trial protocols. In the past, not all         with regional centres to increase numbers contribut-
                                        institutions have submitted the tissue banking compo-         ing samples. In particular, sites that have received
                                        nent to their HRECs at time of trial protocol submis-         funding under the regional grants program are ex-
                                        sion. This should not be considered optional for insti-       pected to make it a priority to include tissue banking
                                        tutions but of course remains optional for patients.          as part of routine ALLG trial activity. Some additional
                                        The generic Tissue Bank consent is still suggested for        strategies might include identifying a PI at major cen-
                                        all institutions, in order to capture ‘non trial’ patients.   tres to establish Tissue Bank routines and to source
                                        A major goal at the time of establishment of the Tis-         funding for local sample coordinator positions.
                                        sue Bank was to offer tissue banking to 90% of all trial      Milestones
                                        patients. This has not yet been achieved, largely due         One important milestones articulated for the
                                        to many institutions not yet having approved tissue           NHMRC enabling grant has now been achieved. The
                                        banking. At the end of 2005, 25 out of 70 institutions        target of a ratio of banking of non-trial:trial patients is
                                        (36%) were contributing consented samples (trial              now 2:1. These non-trial patient samples are diagnos-
                                        specific and unspecified). By the end of 2008 this had        tically annotated however there is no outcomes data.
                                        risen to 42 out of 71 (59%) – a good improvement              A second important milestone was the development
                                        but with still a way to go.                                   of a minimal clinical data set for the trial patients.
                                        Strategies and plans                                          Although there have been discussions agreement has
                                        Routine sample collection now needs to be adopted             not yet been reached as to how this can be achieved.
                                        as a core component of clinical trials. This should           In addition, funding will be required to implement this
                                        include trial specified translational research plus the       program.

                                        Research output April 2008 - April2009
TB001      Mr. Russell Saal, Princess Alexandra   Large Scale Assessment of WT1 as a marker of MRD in           A further 151 samples from 21 patients Dec
Hospital, QLD
                                                  patients with AML treated uniformly in a clinical trial       2008; 204 samples from 19 patients Mar 2009

TB002       Dr. Lorraine Robb, Walter and Eliza Investigation of homeobox gene expression in haema-             A further 21 samples from 21 patients in May
Institute of Medical Research, VIC
                                                tological malignancies                                          2008
TB003    Dr Jennifer Fleming, University of       Donor and Public perceptions towards Tissue Banks             108 surveys sent to consented Tissue Bank
Queensland, QLD
                                                  and Related Human Research Activities                         donors in April 2008

TB010     Prof Alec Morley, Flinders Medical      DNA-based measurement of BCR-ABL in Chronic Mye- 64 samples from 54 patients between July 2008
Centre, SA                                        loid Leukaemia (CML)                             and Jan 2009

TB011      Dr Charles Mullighan, St Jude          High Resolution Profiling of Copy Number Abnormali-           120 samples from 43 patients Mar 2009
Children’s Research Hospital, Memphis, USA        ties in Relapsed Adult ALL

TB012      Prof Harry Iland, Royal Prince Al-     Single nucleotide polymorphisms in obesity-associated         56 samples from 56 patients
fred Hospital, NSW                                genes: do they confer susceptibility to acute promyelo-       Aug2008
                                                  cytic leukaemia?

TB013    Dr Wallace Langdon, University of        Screening for mutations in the c-Cbl cancer-causing           91 samples from 91 patients Nov 2008 and Jan
Western Australia, WA                             gene in human leukaemias                                      2009

TB014 Prof Alec Morley, Flinders Medical          DNA PCR in APML                                               13 samples from 12 patients Jan 2009
Centre, SA

TB015 Dr James Gray, Princess Alexandra           Genome-wide analysis of genetic alterations in AML             9 samples from 2 patients Apr 2009
Hospital, QLD
                                           Page 18
Number 26

                                       Tissue Bank holdings                                                           Samples stored
                                                                                                                         per year
                                           Tissue Bank Holdings
                           (Patient num bers per WHO classification) as of 1st April                                                  No. samples
                                                   2009                                                                   Year
                                                                                                                                        stored
                                        397                                                                               2002             619
   Number of patients




                        400
                                293
                        300                                                                                               2003             700

                        200                   143                                                                         2004             1439
                                                                     105
                        100                            29     52
                                                                            14        12     3       0       1            2005             2207
                           0
                                                                                                                          2006             4572
                                                                       PD
                                       PD




                                                                         D
                                                                        C
                                         O




                                                                         T
                                                            S
                                                     K




                                                                       ST
                               L




                                                                        D




                                                                      IS
                                                                       P
                                                          D
                                                   N




                                                                     IS
                           AM


                                       E




                                                                     H

                                                                     M
                                      M




                                                                   AL
                                                                                                                          2007             6509




                                                                    A
                                                         M
                                                 T/
                                   N




                                                                   H
                                                                   M
                                                                  S/
                                     C




                                                                  M
                                 B




                                                                ID
                                                                    D
                                                                   M




                                                                                                                          2008             7548
                                                            WHO Classification
                                                                                                                          2009             1539
                                                                                                                          Total           25,133

                                   Sample activity per year

                                     No. of samples banked between
                                     2002 - 2009 (as of 7th April 2009)                                                  CONTACT INFORMATION
                                                                                                                            General email address:
   Number os




                               8000                                                                                  allg_tissue_bank@health.qld.gov.au
    Samples




                               6000                                                                                                STAFF
                               4000
                                                                                                                    Ms Megan Ellis
                               2000
                                  0                                                                                 ALLG Tissue Bank Manager
                                          2002       2003     2004   2005    2006          2007    2008      2009   07-3240 5835

                                                                           Year                                     Mrs Andrea J Shaw
                                                                                                                    ALLG Tissue Bank Sample Coordinator
                                                                                                                    (part time)
                                      Tissue Bank holdings                                                          07-3240 5836

                                                                                                                    Dr Lyle McMillen
                          WHO - Major classification                       No. of sam-            No. of pa-        ALLG Tissue Bank Research Scientist
                            non trial and trial)                              ples                 tients           07-3240 5464

                               Acute Myeloid Leukaemia                       12,228                  293            Ms Jana Augsten
                                   B-cell Neoplasms                              6860                397            ALLG Tissue Bank Sample Coordinator
                                                                                                                    07-3240 5838 or 3240 5836
                        Chronic Myeloproliferative Diseases                      3031                143
                           T-cell and NK-cell neoplasms                          1218                29             Mrs Josie Tumamao
                                                                                                                    ALLG Tissue Bank Laboratory Scientist
                            Myelodysplastic syndromes                            843                 52
                                                                                                                    07-3240 5839
                                 Hodgkin Lymphoma                                341                 105
                                                                                                                          Postal address for samples
  Myelodysplastic/Myeloproliferative Diseases                                    360                 14
                                                                                                                                      Attention:
                                     Miscellaneous                               153                 12
                                                                                                                        Staff of the PwC ALLG Tissue Bank
Immunodeficiency associated lymphoproliferative                                                                            Princess Alexandra Hospital
                                                                                  95                     3
                  disorders                                                                                                c/- Haematology/Pathology,
                                                                                                                               Main building level 1
              Histiocytic and dendritic cell neoplasms                            0                      0                          Ipswich Road
                                      Mastocytosis                                4                      1                  Woolloongabba Qld 4102

                                         Total                               25,133                 1049

                                                                                                         Page 19
                 Newsletter June 2009

                 ALLG website


                                                   The ALLG website is undergoing
                                                   constant change and improvement

                                                   So, what are you be able to do?

                                                   If you want to know about what
                                                   events are coming up for the ALLG
                                                   there are three helpful sources for
                                                   you. 1. The Homepage has upcoming
                                                   events listed 2. Go to the News and
                                                   Events Page or 3. Click to view the
                                                   calendar which will be updated regu-
                                                   larly and will include information on
                                                   Meetings, educational events and
                                                   SDMC dates and deadlines for sub-
                                                   missions.
                                                   When you visit your trial page you
                                                   will notice that the layout has
                                                   changed and the location of your
                                                   documents can now be found in one
                                                   location.
                                                   If you click to download button, for
              We have added a ‘Current             trial documents you can either just
              Members’ page to our website,        open the file or you can save the file
              which list the contact information   to your own computer.
              of our 2009 financial members.
              This is only accessible to our       The website has been purposely de-
members through our ‘Member Login’ section.        signed for the ALLG by the IT de-
                                                   partment at Peter MacCallum, who
                                                   also host the site. Thanks to Peter
                                                   Mac for this inkind support to the
                                                   ALLG! Many of the constant and
                                                   daily improvements are provided by
                                                   our Webmistress Extraordinaire Dilu
                                                   Uduwela. Undying gratitude to Dilu!!!




                 Page 20
Number 26

Publications 2009
ALLG Publications 2009
Eve HE, Linch D, Qian W, Ross M, Seymour JF, Smith P, Stevens L, Rule SAJ: Toxicity of fludarabine and cyclophosphamide ± ri-           LY05
tuximab as initial therapy for patients with previously-untreated mantle-cell lymphoma: results of a randomised phase-II study.
Leuk Lymphoma 50:211-5, 2009
Eve HE, Seymour JF, Rule SAJ: Impairment of peripheral blood stem cell mobilisation in patients with mantle-cell lymphoma follow-       LY05
ing primary treatment with fludarabine and cyclophosphamide ± rituximab. Leuk Lymphoma pre-published online Feb 5, 2009
A Spencer, H. M Prince, A. Roberts, I. Prosser, K Bradstock, L Coyle, D Gill, N Horvath, J Reynolds and N Kennedy. Consolida-           MM6
tion Therapy With Low-Dose Thalidomide and Prednisolone Prolongs the Survival of Multiple Myeloma Patients Undergoing a
Single Autologous Stem-Cell Transplantation Procedure. J Clin Oncol 27. Pre-published online Mar 9, 2009
Publications 2009 (associated with the ALLG)
Martinelli G, Ryan G, Seymour JF, Nassi L, Steffanoni S, Alietti A, Calabrese L, Pruneri G, Santoro L, Kuper-Hommel M, Tsang R,
Zinzani PL, Taghian A, Zucca E, Cavalli F: Primary follicular and marginal-zone lymphoma of the breast: Clinical features, prognostic
factors and outcome. A study by the International Extra-nodal Lymphoma Study Group. Ann Oncol in press
Germing U, Hildebrant B, Symeonoidis A, Cermak J, Pfeilstöecker M, Nösslinger T, Sekkeres M, Maciejewski J, Haase D, Schlenk R,
Schanz J, Seymour JF, Kenealy M, Köppler H, Lübbert M, Platzbecker U, Valent P, Blum S, Ottomann O, Götze K, Stauder R,
Kreuzer KA, Aul C, Kündgen A, Giagounidis A: Survival, prognostic factors, and leukemic transformation in a multi-centre study of
241 patient with MDS and del(5q). Leuk Res 33 (Suppl. 1):S74, 2009 (Abstr. P028)

            If your publication or presentation does not appear, it’s
            not because we don’t like you, but because we don’t
            know about it. Please send details to the ALLG Opera-
            tions Office to ensure its appearance in the next newslet-
            ter.




                                                        “Surely you were aware when you accepted this
                                                       position, Professor, that it was publish or perish?”



ALLG publishing history - numbers of publications by year

                             publications           presentations                  other                 total
pre 2000 ALSG                       24                                                                        24
pre 2000 ANZLG                       9                                                                        9
2000                                 1                       1                                                2
2001                                 4                      10                                                14
2002                                 3                       7                         1                      11
2003                                 4                      16                         3                      23
2004                                 2                      16                                                18
2005                                 8                      18                         1                      27
2006                                 9                       4                         3                      16
2007                                10                       9                         2                      21
2008                                 7                       7                         1                      15
2009 (to May)                       3                                                                      3
total                               84                      88                         11                 183
                                                                             Page 21
Newsletter June 2009

ALLG/Roche QA Partnership
The ALLG/Roche QA Partnership is an understanding         vided many opportunities through 2007 and 2008:
between Roche Products and the ALLG to undertake
                                                          Support for attendance of data managers/research nurses
a collaborative approach to the constant improve-
                                                          at suitable training courses in GCP. In 2007 22 were
ment of clinical research practice in the area of hae-
                                                          funded to attend and 31 in 2008.
matological malignancies, under the auspices of the
ALLG.                                                     Support for attendance of members (clinicians) at suitable
                                                          short training courses in GCP. In 2007 funded was pro-
The partnership commenced in January 2007 with the
                                                          vided to 10 clinicians and in 2008 to 15.
intention of continuing for a minimum of 3 years.
                                                          Funding to assist in the provision of one day educa-
The main goal of the partnership is to develop and
                                                          tionals in haematology for data managers/research
maintain a high level of clinical research practice
                                                          nurses. In 2007 courses in lymphoma and acute leu-
among people who are involved in the conduct of
                                                          kaemia were run in conjunction with the biannual
clinical research within the ALLG. The underlying
                                                          ALLG investigators meetings. In 2008, a course in
principles of this goal are to ensure, that research
                                                          myeloma was run in May and a course in CLL is
involving human volunteers is developed and con-
                                                          planned in November.
ducted with the highest level of ethical and scientific
quality in order to minimise human risk and maximise      This valuable partnership and the opportunities which
the benefit to society.                                   it provides has already proved very successful in
                                                          2009, with continued support for both the GCP
The ALLG/Roche QA Partnership, with a focus on
                                                          training and haematology educational sessions.
continuous education and quality assurance, has pro-


GCP training - data managers/research nurses
GCP training has again been offered in 2009 and           pating in ALLG trials and to trial coordinators in the
again there has been an excellent uptake. The             ALLG Trial Centre. Normally funding is for one
courses, provided by Nucleus Network are:                 representative from each active institution per year,
                                                          but depending on demand, there may be funding for a
Good Clinical Practice for Research Profes-
                                                          second person. You are expected to attend a course
sionals (2 days) and Practical Aspects for Clini-
                                                          in your city, but for those outside the main centres,
cal Research Sites (1 day follow up course).
                                                          there is also funding for travel and accommodation.
Funding to attend the course is available to all data
                                                          There is still funding available for a course in 2009 -
managers/research nurses in local institutions partici-
                                                          please contact Janey Stone.

NEW!!! On-line courses for data managers
For those busy souls who can’t get out of the hospital, and for those wanting training only in specific topics,
we now have funding to support web-based training. You can do an entire course or just one or more mod-
ules. Check out what is on offer at the Nucleus Network website (https://www.nucleusnetwork.com.au/
page.aspx?102) and contact Janey Stone if you are interested.



GCP training - clinicians
The one day course GCP for clinical physician             “This is an excellent initiative to improve the capacity for
investigators run by Nucleus Network was run for          the ALLG to conduct clinical research” (experienced
the first time in conjunction with the Scientific Meet-   clinician)
ing in Sydney in May. The day was very successful,        “Main benefit has been in the introduction to the
not least in sending a message to members that GCP        regulatory framework, as this is of ten the major
training is an essential element of trial involvement     hurdle in getting any research up and run-
through the ALLG.                                         ning.” (clinician with intermediate experience)
Some comments:                                            The course will again be run in conjunction with the
                                                          ALLG meeting in November in Melbourne. Watch
Page 22
                                                          out for further information.
                      Newsletter June 2009

                      Other training opportunities
                      Melbourne University Specialist Certificate in
                      Clinical Research (Oncology) - 2009
                      With support from Merck, Sharp and Dohme, the             The ALLG awarded four scholarships to:
                      ALLG was again able to offer scholarships in 2009 to
                                                                                Devendra Hiwase       Royal Adelaide
                      attend the Specialist Certificate in Clinical Research
                                                                                Michael Osborn        Royal Adelaide
                      (Oncology) offered by Melbourne University. Coor-
                                                                                Anna Johnston         Canberra
                      dinated by Michael Jefford, Peter MacCallum, the
                                                                                Julie Ryan            Wollongong
                      course runs over two four-day blocks and involves
                      very intensive study and an exam.
                                                                                It is planned to offer the scholarships again in 2010.
                      Part 1 – Mon 27, Tue 28, Thu 30 April & Fri 1 May,        Once we are informed of the course dates by Mel-
 Michael Jefford      University House, Parkville Campus, Melbourne             bourne University, we will announce availability. For
 Course coordinator                                                             further information on the course:
                      Part 2 - Mon 27, Tue 28, Wed 29 & Fri 31 July,
                                                                                http://www.mccp.unimelb.edu.au/oncology.
                      Graduate House, Carlton, Melbourne



                      Julie Ryan - first research nurse to receive the
                      ALLG scholarship

                      In previous years the ALLG has only been able to offer the scholarship to member clinicians. With the
                      agreement of MSD, in 2009 one place was offered to data managers/research nurses doing ALLG tri-
                      als. Julie Ryan from Wollongong Hospital reports below on her experience of the first module.


                      On 12th February 2009 I was fortunate enough to           The lecturers are very experienced with some lead-
                      receive an ALLG / Merck Sharp &                           ing Medical Oncologists, pharmaceutical representa-
                      Dohme scholarship for the Specialist Certificate in       tives, Radiation Oncologists, Ethics Coordinators
                      Clinical Research (Oncology) at University of Mel-        and Victoria Cancer Council & Cancer Biobank
                      bourne. Not having done any formal study for quite        representatives involved with the course.
                      a few years, due to family and work commit-
                      ments, this course was a daunting prospect for me.        There is a lot of reading and the assignments are
                      The fact that I was the first nurse to be awarded this    intense, but the course will formalise the knowledge
                      scholarship put no pressure on me at all.                 & skills used everyday in clinical trials. I would en-
                                                                                courage any experienced Clinical Trials Co-
                      University of Melbourne is a beautiful venue and the      ordinator/Research Nurse to apply for the scholar-
                      course to date has been very interesting. Good            ship for the course.
                      Clinical Practise and the National Statement on Ethi-
                      cal Conduct in Human Research have been the main
                      focus to date with protocol and clinical trial require-
                      ments included.
Julie Ryan
Wollongong Hospital




                      Page 23
                        Newsletter June 2009

                        News and views
                       Toxicity reporting for trials - CTCAE vs 4
                                                     It is now standard practice        and is available now for use. Check it out at http://
                                                     to record treatment tox-           ctep.info.nih.gov/protocolDevelopment/
                                                     icities using the Toxicity         electronic_applications/ctc.htm#ctc_v40. A number
                                                     Criteria developed by the          of other useful tools are available here too.
                            National Cancer Institute known as Common
                                                                                        Once training materials become available, the ALLG
                            Terminology Criteria for Adverse Events
                                                                                        will include information for data managers/research
                            (CTCAE). In recent years we have all become
                                                                                        nurses in the Data Managers Days associated with
                            accustomed to version 3, but there is news - ver-
                                                                                        the meetings. It is expected that version 4 will be
                            sion 4 is now available.
                                                                                        required in protocols in the future.
  NHMRC
                            CTCAE v4.0 information is in the Public Domain
  announces new

  guidelines for
                        NHMRC revised position on safety reporting
  safety reporting.     The NRMRC recently adopted a revised position                       SUSARs from Australian or international sites to
                        statement on safety reporting for trials. The Position              investigators.
  Significantly less    Statement: Monitoring and Reporting of Safety for Clini-
                        cal Trials Involving Therapeutic Products replaces the          The good news is that sending individual safety re-
  work for sponsors,    HREC Alert issued in April 2007 and clarifies the               ports to investigators is no longer required as a
                        requirements for safety monitoring, reporting and               minimum requirement. This means significantly less
  investigators and                                                                     work for sponsors and investigators and study coor-
                        review of clinical trails.                                      dinators in managing hundreds of individual SAE
  study coordinators    Key Changes:                                                    reports from all over the globe. Instead, 6 monthly
                                                                                        listings (with sponsor advice in regard planned ac-
                        •    use of 6 monthly SUSAR listings rather than 3              tions if any) will suffice for investigators and ethics
                             monthly                                                    committees as a minimum in Australia.
                        •    Only if the investigator, HREC or sponsor con-             The issue needs to be discussed by the SDMC and
                             sider it to be necessary because of the risk, size         the Executive. Hopefully we can report future ar-
                             or complexity of the proposed research, is the             rangements for ALLG trials in the September news-
                             sponsor required routinely to send individual              letter.

The revised position statement is available at
http://www.nhmrc.gov.au/health_ethics/hrecs/reference/_files/090609_nhmrc_position_statement.pdf.




                        Harmonisation of Multi-centre Ethical Review - HoMER
                                                      For years, there has been         One problem is to ensure consistency of review
                                                      talk about the complexity         when carried out by different bodies across Australia.
                                                      and duplication involved in       The information standard will enable a single ethical
                                                      every hospital reviewing          review to be carried out using consistent processes,
                                                      every single trial, but it just   irrespective of whether the participating group of
                                                      seemed to hard to do              institutions is located within or across jurisdictions.
                                                      anything about it. Finally in     Some current activities include a planned survey on
                            2006, the NHMRC started a process called Har-               the experience of HRECs with ethical review of
                            monisation of Multi-centre Ethical Review –                 multi-centre research and pilots of single review
                            HoMER for short. Although not faster than a                 across institutions. The HoMER project publishes a
                            speeding bullet and involving a rather large number         newsletter regularly (contact homer@nhmrc.gov.au)
                            of sub-committees, HoMER seems finally to bear-             and there is also information on the NHMRC website
                            ing fruit. The objective of the initiative is to enable     at http://www.nhmrc.gov.au/health_ethics/homer/
                            the recognition of a single ethical and scientific          homer_news.htm
                            review of multi-centre health and medical research
                            within and/or across Australian jurisdictions.


                        Page 24
Number 26


Updated declaration of Helsinki
The Declaration of Helsinki was first adopted at the 1964 World Medical Association’s (WMA) General Assembly in Hel-
sinki. Its purpose was to provide guidance to physicians engaged in clinical research and its main focus was the responsi-
bilities of researchers for the protection of research subjects. Since then it has been revised several times. The 2000 ver-
sion introduced an entirely new concept – the responsibility of researchers and sponsors to provide benefits to popula-
tions: “Medical research is only justified if there is a reasonable likelihood that the populations in which the research is
carried out stand to benefit from the results of the research” (paragraph 19). Although the nature and extent of these
benefits was not specified, the amendment clearly added a significant public-health component to research ethics. The 6th
revision in October 2008, which replaced all previous versions, has important implications for us. This version highlights
issues such as participant safety, the need to include participants from otherwise under-represented groups, clinical trial
registration, post-study access, usage of data and human tissues, compensating participants with research-related injury,
and usage of placebo.
The new version increases the emphasis on the need for a well-defined protocol. It now states that each protocol must
go beyond a general statement that the research will be conducted according to the declaration. It must now "indicate
how the principles in this Declaration have been addressed". Additionally, the new version states that a protocol must
have "provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the re-
search study." This is a very important inclusion. Another important statement is that "the protocol should describe ar-
rangements for post-study access by study subjects to interventions identified as beneficial in the study or access to other
appropriate care or benefits". An interesting paper by KS Puri, KR Suresh, NJ Gogtay, UM Thatte (Declaration of Helsinki,
2008: Implications for stakeholders in research) discusses many of these and other points in more detail.
See http://www.jpgmonline.com/


National Ethics Application Form (NEAF)
NEAF is a web-based tool that has been developed to enable researchers of all disciplines to complete research ethics proposals for submission to
Human Research Ethics Committees (HRECs), and to assist HRECs to consistently and efficiently assess these proposals. It has been designed to
meet the requirements of relevant guidelines with the aim of increasing the efficiency and quality of the ethical review process for all parties involved.
NEAF allows you to identify more than one HREC to which you will be submitting your proposal, and you can complete one proposal to submit to
multiple HRECs. This removes the need for researchers to prepare multiple application forms and means that all HRECs receive identical information
about the proposal.
You can submit your NEAF proposals to HRECs in either hard copy or electronically, but you should contact your HREC to find out their prefer-
ence. Electronic submission will assist HREC Administrators to maintain efficient record-keeping processes.
Institutions are ultimately responsible for both the conduct of research carried out through their institution, and its review by an HREC. They are
encouraged to facilitate the national consistency through use of NEAF by ensuring that researchers have access to NEAF on-line, and that HRECs
have access to IT resources for database maintenance, and data import, access and storage.
Both NSW and Qld have slightly different system, please check the NHRMC website for further information and updates.


Cancer in rural Australia
The National Rural Health Alliance released a new fact sheet in May detailing
information about the burden of cancer in rural Australia, access to treatment
and support and discussing how to reduce the gap. People living with cancer in
rural areas have poorer survival rates than those living in major metropolitan
centres, and the further from a metropolitan centre patients with cancer live,
the more likely they are to die within five years of diagnosis. A NSW study by
Jong, Smith, Yu et al (reported in MJA in 2004) found that people with cancer in regional areas were 35
per cent more likely to die within five years of diagnosis than patients in cities. For some cancers, re-
mote patients were up to three times more likely to die within five years of diagnosis. In 2005, COSA’s
Regional and Rural Oncology group coordinated the first national mapping of clinical oncology services
in regional and rural hospitals. This study found that there were marked deficiencies in cancer services
in rural and regional areas of Australia and that the quality and availability of services directly influenced
survival rates. The factsheet was prepared by the NRHA in collaboration with COSA.
To download the factsheet go to: http://nrha.ruralhealth.org.au/cms/uploads/factsheets/fact-sheet-08-                                                        Caption de
cancer.pdf. For more information on rural cancer visit the COSA website: www.cosa.org.au.                                                                    graphic.




                                                                                 Page 25
Newsletter June 2009

Clinical Trials Honour Roll
            The AccessCR Clinical Trials Honour Roll was released on May 20th in celebration of Inter-
            national Clinical Trials Day. The ALLG was registered and received a certificate of participa-
            tion. This Honour Roll publicly recognises and celebrates the individuals and organisations
            that have nominated themselves or others for their contribution to clinical trials in Austral-
            asia since Jan 2008, thereby helping to advance medical knowledge for the benefit of the
            entire community. More information at
            www.accesscr.com.au/2009_Clinical_Trials_Honour_Roll




Trial registration news
European recommendations                                   Four years in the history of clinical trial regis-
The European Medical Research Councils, which is           tration
part of the European Science Foundation, published a       When the ICMJE announced that they would no
"Forward Look" report on Investigator-Driven Clini-        longer consider publishing the findings of clinical trials
cal Trials in March 2009. The report contained 26          unless the research had been prospectively regis-
recommendations for improving clinical research in         tered, they were key to shifting the way the clinical
Europe. Recommendation 14 on the publication of            trials community thinks about research transparency.
clinical trials results was that:                          By 2004 there was consistent and convincing evi-
                                                           dence of the existence of publication bias and the
• Negative results as well as positive results are
                                                           damage this does to people’s ability to make well
   published;
                                                           informed decisions about health care. There is now
• Sponsors, funders and all responsible organiza-
                                                           increasing acceptance that the registration of clinical
   tions be obliged to register and publish all clinical   trials in a publicly accessible registry is a scientific,
   trial data regardless of the type of trial or the       ethical and moral responsibility. In 2004, less than
   phase;                                                  3,000 clinical trials were registered on databases
• The WHO recommendations and the WHO                      meeting ICMJE criteria. There are now more than
   clinical trial platform should be implemented           19,000. Further, since October 2008, prospective
   through national governments quickly and regis-         registration is required if researchers wish to comply
   tration should be free of charge and done rapidly;      with the Declaration of Helsinki.
• The quality of data deposited in clinical trials reg-    For more details see:
   istries be improved;                                    Davina Ghersi, Tikki Pang. From Mexico to Mali:
• The transfer of results into clinical practice be        four years in the history of clinical trial registration
   facilitated.                                            JEBM 2009 21: 1-7.



COSA Scientific Meeting
   Over 1500 delegates from Australia and across the Asia Pacific region attended the 35th annual scien-
               tific meeting of the Clinical Oncological Society of Australia (COSA) in Sydney last No-
               vember. Themed on “Information in, information out” one of the highlights of the meet-
               ing was the number of presentations on cancer in indigenous populations. Indigenous
               patients with cancer are diagnosed at a later stage than non-indigenous patients in Austra-
               lia. They are more likely to get cancers with a poorer prognosis and cancers such as lung
               and liver cancers, which are largely preventable. They are less likely to be adequately
               treated and more likely to die than non-indigenous Australians with cancer. The data
               regarding indigenous cancer patients in Australia is limited.


Page 26
Number 26



                                                         CALENDAR
                                         ALLG event                                                   External event


        July             3               SDMC trial review submissions deadline
                         27              SDMC face to face meeting, Sydney
        August           10              Executive meeting, Sydney
                         17-20                                                                        CRX09 Conference, Melbourne
        September        4               Newsletter deadline
                         18              SDMC trial review submissions deadline
                         23              Newsletter published
                         25              Executive teleconference
        October          12              SDMC teleconference
                         18 – 21                                                                      HSANZ, Adelaide
        November         11 - 13         ALLG Scientific Meeting, Melbourne
                         11              Executive face to face, Melbourne
                         17 - 19                                                                      COSA, Gold Coast
                         27              Newsletter deadline
        December         5-8                                                                          ASH, New Orleans
                         16              Newsletter published
                         18              Executive teleconference


        February         (tbc)           Executive meeting,, Melbourne
                         (tbc)           SDMC meeting, Melbourne




ALLG Scientific Meeting - Melbourne, 10-13 November 2009
                                  To be held at the Hilton on the            OUTLINE AGENDA (to be confirmed)
                                  Park, Melbourne, the next Investi-         Tues 10 Nov        Haematology Educational Day for Data Managers
                                  gators meeting of the group will                                        - Bone Marrow Transplant
                                  again feature a haematology educa-
                                                                             Wed 11 Nov
                                  tional for data managers/research
                                                                             09:30 – 17:00      Data Managers & Research Nurses
                                  nurses, a trials focussed data man-
                                                                             08:30 – 17:30      GCP Educational Day for ALLG Clinicians
                                  agers’ day, and the main investiga-
                                                                             18:30 – 19:30      Welcome Reception
                                  tors meeting on Thursday
                                  (leukaemia day) and Friday                 Thurs 12 Nov
                                  (lymphoma day). Attendance is              9.30 - 17.30       “Leukaemia Day”
                                  open to all ALLG members and to            18.30 - 22.30      Dinner Melbourne MCG
data managers/research nurses responsible for ALLG trials. No                Friday 13 Nov
registration fee is charged. Funding is available for one clinician          8.30 - 16.00       “Lymphoma Day”
from each active institution outside Melbourne and Sydney in                 Flyer will be available mid-September.
2009. Funding is also available for one data manager/research
nurse from active institutions. For more information , contact Dilu
Uduwela by email (dilupa.uduwela@petermac.org).                                 Page 27
AUSTRALASIAN                    LEUKAEMIA     AND     LYMPHOMA          GROUP


Executive                           The ALLG sponsors trials in malignant haematology in Aus-       ALLG Operations Office
Chairman: John Seymour              tralia and New Zealand. Trials may be initiated and devel-      Level 2,
John.Seymour@petermac.org           oped under the auspices of the ALLG or may be international     10 St Andrews Place
                                    trials, sponsored in Australia and NZ by the group.             East Melbourne, Vic 3002,
Vice Chairman Pauline Warburton
                                                                                                    Australia
ptwarbur@bigpond.com
                                    The ALLG is open to all clinicians with a special interest in   Operations Staff:
Treasurer: Mark Hertzberg           trials in malignant haematology. ALLG members may attend        Delaine Smith, Operations Manager
mark_hertzberg@wmi.usyd.edu.au      the biannual investigators meetings, receive regular informa-   Phone: +613-9656 3656
                                    tion about activities, and may apply for opportunities for      Email: Delaine.Smith@petermac.org
Secretary: Leanne Berkahn
LBerkahn@adhb.govt.nz
                                    funding for training and other special projects. All ALLG
                                    members may participate in any ALLG trial, providing their      David Ridler, Business Manager
Executive members                   site is approved as approved for the conduct of ALLG trials.    Phone: +613-9656 3667
                                                                                                    Email:David.Ridler@petermac.org
Andrew Wei
A.Wei@alfred.org.au                 For further information about joining the ALLG visit the
                                    website or contact Dilu Uduwela.                                Dilupa Uduwela: Admin & Events
Ian Lewis                                                                                           Phone: +613 9656 3633
ian.lewis@imvs.sa.gov.au                                                                            Email: Dilupa.Uduwela@petermac.org
                                        FUTURE INVESTIGATOR MEETINGS
Devinder Gill
                                                                                                    Megan Sanders: Protocol
devinder_gill@health.qld.gov.au
                                                                                                    Development Coordinator
Joy Ho                                                                                              Phone: +613 9656 1265
joy.ho@email.cs.nsw.gov.au                                                                          Email: Megan.Sanders@petermac.org

Tony Mills                                                                                          Janey Stone: QA and Special Projects
Tony_Mills@health.qld.gov.au                                                                        Phone: +613 9656 1265
                                                                                                    Email: Janey.Stone@petermac.org
Disease Group Chairs:                                                                               Office Fax: +613-9656 1420
Acute Leukaemia/MDS
Andrew Wei, John Seymour

BMT
Leanne Berkahn, Ian Lewis

CML/MPD                               10 - 13 November                  4 - 7 May 2010                  9 - 12 November
Tony Mills, John Seymour
                                             2009                        Hilton Hotel                        Sydney
Aggressive NHL/HL                    Hilton- on-the- Park                  Adelaide                   venue to be confirmed
Devinder Gill, Mark Hertzberg
                                          Melbourne
Low grade NHL/CLL/MM
Pauline Warburton, Andrew
Spencer

Supportive Care
Tony Mills, Peter Bardy

Laboratory Science
Joy Ho, Andrew Roberts

Executive liaison roles
Regional: Pauline Warburton
Tissue Bank: Devinder Gill
CLLARC: Devinder Gill
Pathology review: John Seymour
SDMC: Devinder Gill
                                      We’re on the Web!
New Zealand: Leanne Berkahn

Other liaison                        www.petermac.org/allg
Strategic Planning: Andrew
Spencer, Peter Bardy
WA: Gavin Cull

				
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