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

NCT01732861 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-12-20

No results posted yet for this study

Summary

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 lenalidomide in subjects with Chronic Lymphocytic Leukemia (CLL).

Conditions

  • Leukemia Lymphocytic Chronic B-Cell

Interventions

DRUG

CC-292

CC-292-will be given twice daily on Days 8-28 of Cycle 1 and on Days 1-28 of the remaining 28-day cycles.

DRUG

Lenalidomide

Lenalidomde will be given once daily on Days 1-28 of 28-day cycles.

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • David Liu, MD · Celgene

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-28
Primary Completion
2019-01-23
Completion
2019-01-23

Countries

  • United States
  • Austria

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01732861 on ClinicalTrials.gov