Canadian Cancer Trials Group Bulletins

Trial Management Group

Trial Activation

We are pleased to inform you that IND.216 - A Phase II Study of Buparlisib in Patients with Relapsed and Refractory Chronic Lymphocytic Leukemia - has been centrally activated.

The primary objective of the study is to determine the overall response rate (complete + partial response) to oral buparlisib in patients with relapsed and refractory chronic lymphocytic leukemia.

Secondary objectives include:
  • To evaluate the safety and tolerability of buparlisib administered at 100 mg per day on a 28 day cycle, in patients with previously treated chronic lymphocytic leukemia.
  • To evaluate additional measures of efficacy including:
    • duration of response rate
    • progression free survival
  • To explore potential molecular factors which may be prognostic or predictive of response or of relapse including:
    • correlation between clinical response to buparlisib and MTT assay (cell viability assay) in B-CLL exposed ex-vivo to buparlisib
    • correlation between response to buparlisib and western blot and flow cytometry analysis of key proteins involved in the PI3K pathway
    • identification of mechanisms of resistance among patients who relapse after therapy with buparlisib; and,
  • To prospectively validate a survival prediction scale.

The target sample size is 39 patients.