Status: Closed
Activation Date: 2012JUL24
Closing Date: 2014MAY07
Phase: II
Description: A Phase II Study of AT7519M, a CDK Inhibitor, in Patients with Relapsed Mantle Cell Lymphoma
Eligibility: Patients with documented mantle cell lymphoma non-refractory to prior therapy. Patients must have received at least one and up to 3 prior systemic treatment regimens. Patients must have at least one site of bidimensional disease to be eligible. No pre-existing cardiovascular conditions or symptomatic cardiac dysfunction. Acceptable end-organ function. ECOG 0, 1 or 2.
Objective: Primary: To assess the efficacy (as assessed by objective response rate) of AT7519M when given as a 1 hour intravenous infusion twice weekly for two out of three weeks in patients with relapsed mantle cell lymphoma (MCL). Secondary: - To assess the toxicity, time to progression and response duration of AT7519M in patients with relapsed mantle cell lymphoma. - To explore potential proteomic and metabolic serum markers of clinical response to AT7519M in MCL by assessment of peripheral blood collected at baseline and on study.
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 mantle cell lymphoma. Treatment will be given as a 1 hour intravenous infusion twice weekly for two out of three weeks in patients with relapsed MCL. 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 | I194 | 12 | 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 | I194 | 12 | 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 | I194 | 12 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |