Lymphoma Clinical Trial
Official title:
A Phase 2 Study of SAR245409 in Patients With Relapsed or Refractory Mantle Cell Lymphoma, Follicular Lymphoma, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Diffuse Large B Cell Lymphoma
Primary Objective:
- To evaluate the efficacy of SAR245409 as determined by the objective response rate (ORR)
in patients with 1 of following relapsed or refractory lymphoma or leukemia subtypes: mantle
cell lymphoma (MCL), follicular lymphoma (FL), chronic lymphocytic leukemia (CLL)/small
lymphocytic lymphoma (SLL), or diffuse large B cell lymphoma (DLBCL)
Secondary Objectives:
- To assess duration of response, progression free survival (PFS), and proportion of
patients with PFS at 6 months (24 weeks) in patients with either MCL, FL, CLL/SLL or
DLBCL treated with SAR245409
- To evaluate the safety and tolerability of SAR245409 in patients with MCL, FL, CLL/SLL
or DLBCL
- To further characterize the plasma pharmacokinetics (PK) of SAR245409 in patients with
MCL, FL, CLL/SLL or DLBCL
There is a 21 day screening period followed by 28 day cycles. Patients will continue to receive SAR245409 as long as there is clinical benefit or until a study withdrawal criterion is met. The last posttreatment visit will be 30 days after the last dose or until IMP-related toxicities have resolved or are deemed irreversible, whichever is later. ;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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