Buparlisib in Patients With Relapsed and Refractory Chronic Lymphocytic Leukemia
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Buparlisib in Patients With Relapsed and Refractory Chronic Lymphocytic Leukemia|
- Overall response rate [ Time Frame: 30 months ]To determine the overall response rate (complete + partial response) to oral buparlisib in patients with relapsed and refractory chronic lymphocytic leukemia.
- Number of adverse events in patients [ Time Frame: 30 months ]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.
- Efficacy of buparlisib (duration of response rate and progression free survival); composite outcome measure. [ Time Frame: 30 months ]
- To evaluate additional measures of efficacy including duration of response rate and progression free survival
- To explore potential molecular factors which may be prognostic or predictive of response or of relapse.
- To prospectively validate a survival prediction scale.
|Actual Study Start Date:||January 30, 2015|
|Estimated Study Completion Date:||January 2018|
|Estimated Primary Completion Date:||July 2017 (Final data collection date for primary outcome measure)|
100mg daily orally every 28 days
Buparlisib has been shown to shrink tumours in animals. It has been studied in some people and seems promising but it is not clear if it can offer better results than standard treatment.
The standard or usual treatment for this disease is chemotherapy, targeted therapy or radiation, either alone or in combination.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02340780
|Tom Baker Cancer Centre|
|Calgary, Alberta, Canada, T2N 4N2|
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Winnipeg, Manitoba, Canada, R3E 0V9|
|Canada, Nova Scotia|
|QEII Health Sciences Centre|
|Halifax, Nova Scotia, Canada, B3H 1V7|
|University Health Network|
|Toronto, Ontario, Canada, M5G 2M9|
|The Jewish General Hospital|
|Montreal, Quebec, Canada, H3T 1E2|
|Study Chair:||Sarit Assouline||McGill University - Dept. Oncology, Jewish General Hospital Site, Montreal QC Canada|