Status: Closed
Activation Date: 2012JUN21
Closing Date: 2013NOV22
Phase: II
Description: A Phase II Study of AT7519M, A CDK Inhibitor in Patients with Relapsed and/or Refractory Chronic Lymphocytic Leukemia.
Eligibility: Patients with documented chronic lymphocytic leukemia with at least one and up to 3 prior systemic treatment regimens. Patients must have either lymphocyte count >= 10 x 109/L or at least one measurable lymph node >= 2 cm x 2 cm to be eligible. No pre-existing cardiovascular conditions or symptomatic cardiac dysfunction. Acceptable end-organ function. ECOG 0, 1 or 2.
Objective: To assess the efficacy of AT7519M when given as a 1 hour intravenous infusion twice weekly for two out of three weeks in patients with relapsed and/or refractory chronic lymphocytic leukemia. To assess the toxicity, time to progression and response duration of AT7519M in patients with relapsed/refractory CLL. To demonstrate the pharmacodynamic activity of AT7519M in patients with relapsed and/or refractory CLL by establishing its effects on relevant biological endpoints (markers of CDK inhibition, apoptotic markers and cell cycle suppressors) in circulating lymphocytes. To investigate the relationship between baseline cytogenetics and other molecular markers in response to AT7519M.
Participation: Limited to invited centres
Lay Description: The main purpose of this study is to find out how effective the study drug AT7519M is in treating chronic lymphocytic leukemia. Treatment will be given as a 1 hour intravenous infusion twice weekly for two out of three weeks in patients with relapsed/refractory CLL. Patients will be those who meet all of the eligibility criteria. Treatment will be repeated every 3 weeks (1 cycle = 3 weeks) and will continue for up to 4 cycles as long as the cancer does not progress and the side effects are not too severe and the patient wishes to. If patients achieve a response to treatment, they may be on the study until the cancer worsens or for 2 more cycles after they show a response
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| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| IND | I193 | 7 | 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 | I193 | 7 | 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 | I193 | 7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |