|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.