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 Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma, Mantle Cell Lymphoma or Chronic Lymphocytic Leukemia
All subjects will take SAR245409 twice daily. All subjects will receive SAR245409 as long as
there is clinical benefit.
Combination therapy with SAR245409 and either bendamustine or rituximab as doublet therapy,
or with bendamustine and rituximab as triplet therapy, will be administered over a 28 day
Subjects receiving the doublet containing rituximab will receive rituximab for 4 - 8 weeks.
Subjects with iNHL or MCL receiving bendamustine as a triplet therapy will receive a maximum
of 8 cycles of therapy. Subjects CLL receiving bendamustine as a triplet therapy will
receive a maximum of 6 cycles of therapy.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Identification Of Dose-Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD)
4 weeks to 8 weeks
Clinical Sciences & Operations
United States: Food and Drug Administration
|Investigational Site Number 840006||Augusta, Georgia 30912|
|Investigational Site Number 840004||Aurora, Colorado 80045|
|Investigational Site Number 840001||New Brunswick, New Jersey 08903|
|Investigational Site Number 840002||Charleston, South Carolina 29406|
|Investigational Site Number 840003||Dallas, Texas 75230|