Safety Study of CC-292 and Rituximab in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Conditions

• Leukemia Lymphocytic Chronic B-Cell

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• CC-292 — DRUG
  Cohort 1: 375 mg CC-292 will be administered twice a day on Days 1-28 Cohort 2: 500 mg CC-292 will be administered twice a day on Days 1-28
• Rituximab — DRUG
  Cohort 1: Rituximab once per cycle Cohort 2: Rituximab once per cycle

Study Details

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.

Key Dates

Start date

Dec 31, 2012

Status verified

Apr 2016

Primary completion

Dec 31, 2015

Completion

Dec 31, 2015

Study Design

Enrollment

40 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: CC-292 with Rituximab
  Dose Escalation

Primary Outcome Measure

Adverse Events [ Time Frame: Up to a year ]

Locations (4)

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