Canadian Cancer Trials Group Bulletins

Trial Management Group


Trial Activations

Canadian Cancer Trials Group MA.32D - Change In Mammographic Density with Metformin Use: A Companion Study to Canadian Cancer Trials Group Study MA.32

The MA.32 Team is pleased to announce the central activation in Canada of MA.32D / A211201, a companion study to MA.32 led by The Alliance for Clinical Trials in Oncology. This trial has been open in the United States since August 2012 with 91 patients enrolled as of January 31, 2015. The accrual target is 458.

The primary objective of this study is to evaluate the change in percent mammographic density in the contralateral (unaffected) breast from prior to the initiation of metformin or placebo treatment through one year of therapy in patients with hormone receptor negative cancer. (A secondary objective is to evaluate this same change over two years of MA.32 treatment.)

Since accrual in North America to MA.32 has been closed for two years, potentially eligible patients for this companion study can be identified from the MA.32 database and communicated to our MA.32 sites - both in Canada and in the United States. We are pleased to have the opportunity to contribute to this trial and assist the Alliance in achieving its accrual target.

Sincere thanks to all who helped prepare for this long-awaited event!

___________________________________________

Canadian Cancer Trials Group CLC.2E - A Prospective Economic Analysis of Canadian Cancer Trials Group CLC.2/ALLIANCE A041202: A Randomized Phase III CLL Study of Bendamustine Plus Rituximab versus Ibrutinib Plus Rituximab versus Ibrutinib Alone in Untreated Older Patients (>= 65 Years of Age) With Chronic Lymphocytic Leukemia

Canadian Cancer Trials Group CLC.2E was centrally activated on March 13, 2015. CLC.2E is a companion economic analysis study that will be conducted at all Canadian centres enrolling patients in the core CLC.2/A041202 protocol.

The primary objective of this trial is to determine the incremental cost-utility ratio, as measured in cost per quality-adjusted life-years gained, of ibrutinib-containing regimens compared to bendamustine-rituximab in elderly patients with CLL (Canadian subset of patients). The primary analysis will compare ibrutinib-rituximab with bendamustine-rituximab.

Secondary objectives include to:
  • Determine the incremental cost-utility ratio, as measured in cost per quality-adjusted life-years gained, of ibrutinib-alone compared to bendamustine-rituximab in elderly patients with CLL.
  • Determine the incremental cost-utility ratio, as measured in cost per quality-adjusted life-years gained, of ibrutinib-rituximab compared to ibrutinib alone in elderly patients with CLL.
  • Determine if there is extended dominance exerted by ibrutinib-rituximab or ibrutinib when compared to bendamustine-rituximab in elderly patients with CLL.
  • Determine the incremental cost-effectiveness, as measured in cost per life-years gained, of ibrutinib-containing regimens compared to bendamustine-rituximab in elderly patients with CLL.
  • Determine the incremental cost-utility comparing bendamustine-rituximab, ibrutinib, and ibrutinib-rituximab according to biologic subgroups, including del(17p13.1), del(11q22.3), Zap-70 methylation at CpG3, and according to baseline IgVH mutational status and miR profile.
  • Present disaggregated direct medical costs associated with treatment with ibrutinib-rituximab, ibrutinib alone, and bendamustine-rituximab.
  • Describe the resource utilization (hospitalizations, outpatient ambulatory visits including hematology and ophthalmology assessments, chemotherapy suite visits, transfusions, concomitant medications) associated with the three treatment arms.
  • Determine the change in utility over time comparing the three treatment arms.