Chronic Lymphocytic Leukemia Clinical Trial
Official title:
A Phase 1b, Multicenter, Open-Label, Dose Escalation Study of SAR245409 to Evaluate the Safety, Tolerability and Clinical Activity of SAR245409 in Combination With Rituximab or Bendamustine Plus Rituximab in Patients With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma, Mantle Cell Lymphoma or Chronic Lymphocytic Leukemia
Primary Objective:
- To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for
SAR245409 when administered in combination with rituximab or bendamustine plus rituximab
Secondary Objectives:
- To determine the safety and tolerability of SAR245409 in combination with rituximab or
bendamustine plus rituximab in subjects with indolent Hon-Hodgkin Lymphoma (iNHL)
Mantle Cell Lymphoma (MCL) or Chronic Lymphocytic Leukemia (CLL)
- To determine the pharmacokinetics (PK) of SAR245409, bendamustine and rituximab when
used in combination in subjects with iNHL, MCL or CLL
- To determine the pharmacodynamic (PD) effects of SAR245409 in combination with
rituximab or bendamustine plus rituximab in subjects with iNHL, MCL or CLL
- To determine the antitumor activity of SAR245409 in combination with rituximab or
bendamustine plus rituximab in subjects with iNHL, MCL or CLL
All subjects will take SAR245409 twice daily. All subjects will receive SAR245409 as long as
there is clinical benefit.
Combination therapy with SAR245409, bendamustine and rituximab , will be administered over a
28 day cycle for up to 6 to 8 cycles.
Subjects receiving the doublet combination , SAR245409 plus rituximab will receive weekly
rituximab for 4 - 8 weeks. Monthly Rituximab may be continued beyond 8 weeks.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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