Status: Closed
Activation Date: 2015JAN30
Closing Date: 2017JAN24
Phase: II
Description: Phase II Study of Buparlisib in Patients with Relapsed and Refractory Chronic Lymphocytic Leukemia
Eligibility: Patients with previously documented CLL that is recurrent or relapsed after previous therapy and that requires treatment. Patient must have at least one of the following: lymphocyte count >or= 10 x 10/9/L OR at least one pathologically enlarged lymph node (>or= 2 x 2 cm) by CT scan. Patients must have received at least 1 prior systemic treatment regimen (single agent or combination therapy) and recovered from all reversible toxicity related to prior chemotherapy and have adequate washout period. ECOG 0-2. At least 14 days since major surgery and 21 days since prior radiation therapy.
Objective: To determine the overall response rate (complete + partial response). To evaluate the safety and tolerability of buparlisib. 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 including: correlation between clinical response and MTT 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; to prospectively validate a survival prediction scale.
Participation: Limited to invited centres
Lay Description: The main purpose of this study is to determine the overall response rate and evaluate the safety and tolerability of buparlisib and explore potential molecular factors which may be prognostic or predictive of response or of relapse in patients with relapsed and refractory chronic lymphocytic leukemia.
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Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| IND | I216 | 14 | 0 | 0 | 0 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| IND | I216 | 14 | 0 | 0 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| IND | I216 | 14 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |