Leukemia Lymphocytic Chronic B-Cell Clinical Trial
Official title:
A Phase 1b, Multi-center, Open Label, Study to Determine the Safety and Activity of CC-292 in Combination With Rituximab in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma.
This is a dose finding study using a 3 + 3 dose escalation and expansion design to determine a Not Tolerated Dose (NTD), Optimal Biological Effect Dose (OBE) and / or Maximum Tolerated Dose (MTD). These data will be used to establish a Recommended Phase 2 Dose (RP2D) for the combination of CC-292 and Rituximab in subjects with CLL.
This dose finding study uses a 3 + 3 dose escalation and expansion design to establish the
recommended Phase 2 dose (RP2D). Treatment will consist 28 day treatment cycles with a
single Rituximab infusion per cycle for 6 cycles and twice daily (days 1-28) administration
of CC-292 with a starting dose cohort of 375mg twice a day. Following safety review of the
data from the initial cohort and confirmation that the initial dose is tolerable, the next
dose level will be enrolled with a once per cycle Rituximab infusion for 6 cycles and twice
daily CC-292 at 500 mg.
Determination of the maximum tolerated dose and/or optimal biologic effect will be used to
establish a dose for evaluation in an expansion cohort of 24 subjects. Evaluation of the
data for subjects in the expansion cohorts will result in establishment of a RP2D.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01732861 -
Safety Study of CC-292 and Lenalidomide in Subjects With Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma
|
Phase 1 |