A Study of Investigational SAR245409 in Patients With Certain Lymphoma or Leukemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

167 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-09-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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mantle cell

50 mg twice daily: no eating for 2 hours prior and 1 hour after dose

Group Type EXPERIMENTAL