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Clinical Trials: Information

Lymphoma Australia (LA) is a member of the Lymphoma Coaltion and it is our aim to ensure Australians are provided with information about clinical trials in Australia and across the world.

However, LA does not provide medical advice or endorse specific treatments but we hope Australian patients will become more aware of the value of clinical trials and new research. You are strongly encouraged to discuss with your doctor your treatment options as they have  your  medical history and can best evaluate all of the study criteria to determine if the clinical trial is appropriate for you.

Access to new and developing treatments for Lymphoma

  • Policy and advocacy is an important part of Lymphoma Australia’s focus as we work to improve access to new and developing therapies for Australians affected by lymphoma. This is a complex area and unfortunately many Australians have very little comprehension of how access to drugs can impact on them and their families.On the whole we assume the hospital or Medicare will cover our costs but this is not always the case. Therefore, it is important that the lymphoma voice is heard and valued by the relevant decision makers when new treatments are showing or supporting improved quality of life, longer remission periods or a potential cure.
  • Earlier this year Lymphoma Australia participated in a 2 day meeting hosted by the Cancer Drugs Alliance to discuss how new cancer drugs can be made available in a time frame to meet the needs of the current patient. This discussion also focused on the sustainability of increasing prices  to ensure future access was not compromised.  The meeting included key cancer clinicians and representatives from cancer consumer groups , the Department of Health, the PBAC and pharmaceutical companies. International speakers also spoke about how their countries make new drugs available and a series of workshops discussed ways for Australia to make progress in this area.
  • A current challenge for patient consumer groups like Lymphoma Australia is the short time frame for us  to provide input into the decision making process and even knowing in advance that new drugs relevant to the lymphoma community are being assessed. However, this year we have provided submissions to  the Pharmaceutical Benefits Advisory Committee (PBAC) in support of Brentuximab Vedotin for Systemic Anaplastic Large Cell Lymphoma (sALCL), the review of maintenance mabthera for non-Hodgkin lymphoma and access to Obinutuzumab for patients with previously untreated CD20 positive chronic lymphocytic leukemia. We will continue to advocate for and support submissions for world's best care for Australian lymphoma patients. 

Brentuximab Vedotin (ADCETRIS®)

New targeted therapy is now reimbursed to patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL) in Australia, following PBS listing.

  • As of 1st December 2014, a new treatment called brentuximab vedotin (brand name ADCETRIS®) will be reimbursed for the treatment of relapsed or refractory systemic Anaplastic Large Cell Lymphoma (sALCL) in Australia, following listing on the Pharmaceutical Benefits Scheme (PBS).

What is brentuximab vedotin (ADCETRIS®)?

  • Brentuximab vedotin belongs to a class of medications called antibody-drug conjugates. It works by specifically targetingthe CD30 protein found on the surface of cancer cells and delivering a toxic drug directly to those cells. Brentuximab vedotin injection is used to treat patients with sALCL whose disease has progressed on or following front-line therapy.The treatment is delivered via a single 30-minute infusion every 3 weeks for a minimum of 8, and up to a maximum of 16, cycles unless the patient experiences disease progression or unacceptable toxicity. 

What are the key data from the pivotal clinical trial?

  • In the pivotal phase II clinical trial, 86 per cent of patients with relapsed or refractory sALCL achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) with brentuximab vedotin treatment, and 97 per cent of patients achieved tumour reductions. 
  • After receiving brentuximab vedotin treatment, the estimated 3-year overall survival rate was 63%.

Who is eligible to receive brentuximab vedotin?

  • Brentuximab vedotin has been listed by the Pharmaceutical Benefits Scheme for treatment of adult patients with relapsed or refractory sALCL who have not responded to at least one prior cycle of combination chemotherapy and are suitable for further curative intent therapy. Your clinician will assess your status and whether brentuximab vedotin may be an appropriate treatment option for you.

Exciting developments: search for a cure

Individualized treatment in Hodgkin Lymphoma: one step closer?

Hodgkin Lymphoma is unusual amongst lymphomas. There are two age peaks: 15 to 30 years (it is the commonest lymphoma in young adults) and then again in the older (over 50’s) age group. Although remission rates are high, not everyone is so lucky, and some patients have resistant or relapsed disease that is difficult to cure.

A particular challenge is how best to monitor patients to assess their response to treatment, and how to pick up relapse early. If this can be done accurately, clinicians will be better able to tailor treatment to individual patients, which has the potential to result in better outcomes. Ground-breaking research conducted at the Translational Research Institute in Brisbane, by Professor Maher Gandhi and Dr Kimberley Jones, has identified tiny fragments of genetic material aptly called ‘microRNA’, that appear to mirror the disease.

These microRNA are raised at diagnosis, and then reach normal levels as the disease starts to shrink once treatment has started. However the levels stay raised if the lymphoma is resistant to treatment, alerting the doctor that the treatment needs to be altered. Furthermore, it appear that if the lymphoma returns the microRNA levels rise again, allowing early detection before the disease becomes too advanced. The findings were published in the prestigious journal ‘Clinical Cancer Research’ (Jones et. al. 2014, 20(1):253-64). The team have recently received funding from the NHMRC to perform a new study, which aims to expand these findings in a large group of Hodgkin Lymphoma patients from Australia and the UK 

Click here for more information 

http://www.som.uq.edu.au/research/research-centres/centre-for-experimental-haematology.aspx

New Clinical Trial in Australia for previously treated Waldenstrom’s Macroglobulinemia

Study title

A Randomed, Double-Blind, Placebo-Controlled, Phase 3 Study of Ibrutinib in Combination with Rituximab in Subjects with Previously Treated Waldenstrom’s’s Macroglobulinemia

Waldenstrom’s macroglobulinemia (WM) is a low grade B cell Non-Hodgkin Lymphoma which constitutes 1-2% of hematologic malignancies. To date, there is no US Food and Drug Administration (FDA), European Medicines Agency (EMA) or Therapeutic Good Administration (TGA) approved treatment for WM. Treatment options currently used were originally developed from other lymphoproliferative diseases. Rituximab is a monoclonal antibody directed against CD20; when given either as a single agent or in combination, it is currently a recommended therapy for previously treated and untreated WM in international consensus guidelines.

Recently, a somatic mutation of the MYD88 gene (L265P) has been identified that appears to drive WM growth and proliferation. The MYD88 L265P mutation is present in more than 90% of tumor samples from patients with WM. Ibrutinib is a potent and selective inhibitor of BTK, which reduces the association of BTK to MYD88 L265P. Inhibition of BTK blocks downstream B-cell receptor (BCR) signaling pathways and thus prevents B-cell proliferation. The rationale for use of ibrutinib in this indication is based on the results from previous studies that demonstrate promising single-agent activity in subjects with previously treated WM patients.

The primary objective of the proposed multinational study is to evaluate the effect of the addition of ibrutinib to rituximab on progression-free survival in subjects with previously treated Waldenstrom’s macroglobulinemia (WM). In addition, this study aims to confirm the safety and tolerability of ibrutinib when combined with rituximab therapy compared to rituximab in combination with placebo.

Approximately 150 subjects will be randomized in a 1:1 ratio to receive ibrutinib and rituximab (Treatment Arm A) or placebo and rituximab (Treatment Arm B). The study duration is estimated to be 4 years with approximately 1 year of enrollment and 3 years of follow up. All subjects in Arms A and B will receive oral study drug (ibrutinib or matching placebo), administered daily and continuously until criteria for permanent discontinuation of study drug are met.

Canberra is one of the 4 centres this study will open in; if you think you may be eligible for the study, please ask your doctor to contact the Principal Investigator, Dr. Dipti Talaulikar at 02 6244 2487.

Advanced Follicular Lymphoma

Selecting the appropriate first-line treatment for patients with follicular non-Hodgkin lymphoma (FL) has been the source of both debate and controversy for the last 40 years.  However, results from four large phase III randomised studies have clearly demonstrated huge improvements in both event-free survival and progression-free survival when rituximab is given in combination with chemotherapy. Three of the trials also demonstrated improved overall survival. Consequently, it is now unthinkable to give induction chemotherapy without rituximab. What remains unclear is which chemotherapy regimen should be administered with rituximab to provide optimal results.

See more at:

http://jco.ascopubs.org/content/early/2013/03/21/JCO.2012.47.7315.short?rss=1

National Comprehensive Cancer Network (NCCN) - 19th Annual Conference

At the recent conference, experts discussed this year’s updates to the NCCN Clinical Practice Guidelines in Oncology.

The meeting also included reviews of NCCN Task Force reports on issues in supportive care. We asked eleven NCCN panel members to select the most significant updates and insights presented at the conference.  

Non-Hodgkin Lymphoma

Steven M. Horwitz, MD Memorial Sloan Kettering Cancer Center

“The most significant changes are the addition of two newly approved agents for chronic lymphocytic leukemia, obinutuzumab and ibrutinib. That’s quite a lot in a single year. These drugs have the potential to make major changes in how we treat patients, particularly as we have more important non-chemotherapy options. Additionally, the brand-new guidelines for several rare lymphomas are important educational tools. Because they are for rarer diseases, they will hopefully provide useful guidance for clinicians who infrequently encounter these illnesses.” 

Obinutuzumab (Gazyva) plus chlorambucil was added as an option for previously untreated patients with chronic lymphocytic leukemia (CLL). The combination therapy is an option for those patients without an 11q or 17p deletion who are frail with significant comorbidities, and both older and younger patients either with or without comorbidities. The combination is also an option for CLL patients with either an 11q or 17p deletion. Ibrutinib (Imbruvica) was added as a treatment option for CLL patients with or without an 11q or 17p deletion who have received at least one prior therapy. 

For patients with diffuse large B-cell lymphoma, recommended follow-up imaging posttreatment was changed from CT scans every “6 months to 2 years” to “only as clinically needed.” PET-CT scan should now be considered to evaluate at presentation and following initial response to therapy in follicular lymphoma. Rituximab Rituxan) plus low-dose CHOP chemotherapy (R-mini-CHOP) was added under a separate heading for patients with comorbidities aged ≥80 years with aggressive B-cell lymphoma. Two additional guidelines for two rare lymphomas added: Primary Cutaneous CD30+ T-Cell Lymphoproliferative Disorders T-cell Large Granular Lymphocyte Leukemia “These guidelines are largely educational to define these diseases and help clinicians accurately recognize and distinguish these disorders from other types of lymphomas or even benign, reactive processes. There are also some basic therapy recommendations. Because there is little data on these disorders, these recommendations are largely based on expert experience and retrospective studies.”  

Waldenström’s Macroglobulinemia, Multiple Myeloma Kenneth C. Anderson, MD Dana-Farber/Brigham and Women’s Cancer Center “The updates for Waldenström’s incorporate major progress in our ability to identify a common mutation that helps determine proper treatment. Waldenström’s Macroglobulinemia Ibrutinib Imbruvica) now appears as a non–stem cell toxic, salvage therapy option. MYD88 L265P AS-PCR testing of bone marrow has proven itself useful in working up certain patients. The intent of therapy should be based on palliation of symptoms and not necessarily levels of IgM, unless the patient is exhibiting evidence of symptomatic hyperviscosity. – 

See more at:

http://www.onclive.com/publications/obtn/2014/May-2014/2014-NCCN-Guideline-Updates-Experts-Highlight-New-Recommendations-for-Clinical-Practice#sthash.Pgl8cT61.dpuf

Global trials

Mantle Cell Lymphoma (MCL)

Study MCL-2001

Purpose
  • The purpose of this study is to evaluate the efficacy and safety of ibrutinib in patients with mantle cell lymphoma who received at least 1 prior rituximab-containing chemotherapy regimen and who progressed after bortezomib therapy.
Official Title
  • A Phase 2, Multicenter, Single-Arm, Study to Evaluate the Efficacy and Safety of Single-Agent Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Subjects With Mantle Cell Lymphoma Who Progress After Bortezomib Therapy.
Study Start Date
  • August 2012
Estimated Study Completion Date
  • October 2013
Enrolment
  • Global

To find out more information about this study and how to enrol, click here.

Study MCL-3001

Purpose
  • The purpose of this study is to evaluate the efficacy and safety of ibrutinib versus temsirolimus in patients with relapsed or refractory mantle cell lymphoma who received at least 1 prior chemotherapy regimen.
Official Title
  • A Randomized, Controlled, Open-Label, Multicenter Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, Versus Temsirolimus in Subjects With Relapsed or Refractory Mantle Cell Lymphoma Who Have Received at Least One Prior Therapy.
Study Start Date
  • December 2012
Estimated Study Completion Date
  • March 2017
Enrolment
  • European Union

To find out more information about this study and how to enrol, click here.

Chronic Lymphocytic Leukemia (CLL)

Study CLL-3001

Purpose
  • The purpose of this study is to examine the safety and efficacy of Ibrutinib administered in combination with bendamustine and rituximab in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Official Title
  • Randomized, Double-blind, Placebo-controlled Phase 3 Study of Ibrutinib, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Combination With Bendamustine and Rituximab (BR) in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma.
Study Start Date
  • September 2012
Estimated Study Completion Date
  • March 2018
Enrolment
  • Global

To find out more information about this study and how to enrol, click here.

Study PCYC-1112

Purpose
  • The purpose of the study is to evaluate whether treatment with ibrutinib as a monotherapy results in a clinically significant improvement in progression free survival (PFS) as compared to treatment with ofatumumab in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL).
Official Title
  • A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma.
Study Start Date
  • June 2012
Estimated Study Completion Date
  • December 2015
Enrolment
  • Global

To find out more information about this study and how to enrol, click here.

Study PCYC-1115

Purpose
  • A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 versus Chlorambucil in Patients 65 Years or Older with Treatment-naive Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.
Official Title
  • A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 Versus Chlorambucil in Patients 65 Years or Older With Treatment-naive Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (RESONATE™-2)
Study Start Date
  • January 2013
Estimated Study Completion Date
  • February 2016
Enrolment
  • Global

To find out more information about this study and how to enrol, click here.

Study PCYC-1115-CA

Purpose
  • An Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA (PCI-32765 Versus Chlorambucil).
Official Title
  • An Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA (PCI-32765 Versus Chlorambucil).
Study Start Date
  • January 2013
Estimated Study Completion Date
  • February 2018
Enrolment
  • Global

To find out more information about this study and how to enrol, click here.

Study PCYC-1117

Purpose
  • An Open-label, Single arm, Multicenter Phase 2 Study of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 (Ibrutinib) in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma with 17p Deletion.
Official Title
  • An Open-label, Single Arm, Multicenter Phase 2 Study of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 (Ibrutinib) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma With 17p Deletion (RESONATE™-17).
Study Start Date
  • January 2013
Estimated Study Completion Date
  • March 2016
Enrolment
  • Global

To find out more information about this study and how to enrol, click here.

Study BO21004

Purpose
  • This open-label, randomized, 3-arm study will evaluate the efficacy and safety of RO5072759 in combination with chlorambucil as compared to rituximab plus chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic leukemia. Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles of either RO5072759 (1000mg iv infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2-6) plus chlorambucil (0.5mg/kg orally, days 1 and 15 of cycles 1-6), or rituximab (iv infusion day 1, 375mg/m2 cycle 1, 500mg/m2 cycles 2-6) plus chlorambucil, or chlorambucil alone. Anticipated time on study treatment is >6 months and follow-up for disease-progression and safety will be at least 5 years.
Official Title
  • An Open-label, Multi-center, Three Arm Randomized Study to Investigate the Safety and Efficacy on Progression-free Survival of RO5072759 + Chlorambucil (GClb) Compared to Rituximab + Chlorambucil (RClb) or Chlorambucil (Clb) Alone in Previously Untreated CLL Patients With Comorbidities.
Study Start Date
  • December 2009
Estimated Study Completion Date
  • September 2021
Enrolment
  • Global

To find out more information about this study and how to enrol, click here.

Diffuse Large B-Cell Lymphoma (DLBCL)

Study GAO4915g

Purpose
  • This open-label, multicenter study will evaluate the efficacy and safety of RO5072759 (GA101) in combination with CHOP chemotherapy in patients with advanced diffuse large B-cell lymphoma. Patients will receive 8 cycles of RO5072759 (1000 mg intravenously on Day 1 of each 21-day cycle, during Cycle 1 RO5072759 will also be infused on Days 8 and 15) in combination with CHOP (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) chemotherapy during cycles 1 to 6.
Official Title
  • A Phase II, Open-Label, Multicenter Study of Efficacy, Safety, and Biomarkers in Patients With Previously Untreated Advanced Diffuse Large B-Cell Lymphoma Treated With GA101 (RO5072759) in Combination With CHOP Chemotherapy.
Study Start Date
  • August 2011
Estimated Study Completion Date
  • October 2016
Enrolment
  • USA

To find out more information about this study and how to enrol, click here.

Study BO21005

Purpose
  • This open-label, randomized, parallel group study will evaluate the efficacy and safety of obinutuzumab (RO5072759) in combination with CHOP chemotherapy versus MabThera/Rituxan (rituximab) with CHOP in previously untreated patients with CD20-positive diffuse large B-cell lymphoma. Patients will be randomized to receive either obinutuzumab 1000 mg intravenously (iv) every 21 days or MabThera/Rituxan 375 mg/m2 iv every 21 days for 8 cycles, in addition to 6-8 cycles of CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine and prednisolone) iv every 21 days. Anticipated time on study treatment is 24 weeks.
Official Title
  • A Phase III, Multicenter, Open-label Randomized Trial Comparing the Efficacy of GA101 (RO5072759) in Combination With CHOP (G-CHOP) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients With CD20-positive Diffuse Large B-cell Lymphoma (DLBCL).
Study Start Date
  • July 2011
Estimated Study Completion Date
  • May 2018
Enrolment
  • Global

To find out more information about this study and how to enrol, click here.

Indolent Non-Hodgkin Lymphoma

Study GAO4753g

Purpose
  • This open-label, multicenter, randomized, Phase III study will investigate the efficacy and safety of RO5072759 (GA101) combined with bendamustine compared with bendamustine alone in patients with rituximab-refractory, indolent Non-Hodgkin lymphoma (NHL). Patients will be randomized to receive a maximum of 6 cycles of GA101 (1000mg iv infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2 - 6) and then every 2 months until disease progression for up to 2 years plus bendamustine (90 mg/m2 IV, on days 2 and 3 of cycle 1 and days 1 and 2 of cycles 2 - 6) on 28 day cycles or a maximum of 6 cycles of bendamustine alone (120 mg/m2 IV, on days 1 and 2 of cycles 1 - 6) on 28 day cycles.
Official Title
  • An Open-Label, Multicenter, Randomized, Phase III Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+RO5072759 (GA101) in Patients With Rituximab-Refractory, Indolent Non-Hodgkin Lymphoma.
Study Start Date
  • April 2010
Estimated Study Completion Date
  • March 2018
Enrolment
  • Canada, USA, European Union

To find out more information about this study and how to enrol, click here.

Study BO21223

Purpose
  • This open-label, randomized study will assess the efficacy and safety of obinutuzumab (RO5072759) in combination with chemotherapy compared to MabThera/Rituxan (rituximab) with chemotherapy followed by obinutuzumab or MabThera/Rituxan maintenance in patients with untreated advanced indolent non-Hodgkin lymphoma. After the end of the induction period, patients achieving response (CR or PR) will go on to a maintenance period thereby continuing on their randomized antibody treatment alone every 2 months until disease progression for a total of 2 years. Anticipated time on study treatment is up to approximately 2.5 years. After maintenance or observation patients will be followed for 5 years until progression. After progression, patients will be followed for new anti-lymphoma therapy and overall survival until the end of the study.
Official Title
  • A Multicentre, Phase III, Open Label, Randomized Study in Previously Untreated Patients With Advanced Indolent Non-Hodgkin Lymphoma Evaluating the Benefit of GA101 (RO5072759) + Chemotherapy Compared to Rituximab + Chemotherapy Followed by GA101 or Rituximab Maintenance Therapy in Responders.
Study Start Date
  • July 2011
Estimated Study Completion Date
  • March 2022
Enrolment
  • Global

To find out more information about this study and how to enrol, click here.

Updates for CLL/SLL trials

  • The ibrutinib clinical updates at EHA released in two oral presentations include: 1) updated safety and efficacy data from the Phase Ib/II CLL/SLL single agent trial (PCYC-1102); and 2) updated safety and efficacy data from the Phase Ib/II CLL/SLL combination trial with bendamustine and rituximab in relapsed or refractory patients (PCYC-1108). The trial results of PCYC-1102 were updated at EHA with progression-free survival (PFS) data from the relapsed/refractory CLL/SLL patients, including PFS data for high-risk 17p deletion CLL patients, and newly presented immunoglobulin data in the treatment naive patients with a median follow up of 14.4 months. The trial results of PCYC-1108 were updated at EHA with three patients that received an ibrutinib combination with fludarabine/cyclophosphamide/rituximab (FCR).

Clinical Trial information in Australia can be found at the following websites:

  1. Australia Leukaemia and Lymphoma Group
  2. Cancer Trial Australia
  3. Australian/New Zealand Clinical Trials Registry
  4. NHMRC Clinical Trials Centre
  5. Queensland Clinical Trials Network Inc.