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Study of Lenalidomide to Evaluate Safety and Efficacy in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

NCT00963105 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2018-10-31

Study results available
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Summary

The purpose of this study is to determine the safety and effectiveness of different dose regimens of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia (CLL).

Conditions

  • Relapsed or Refractory Chronic Lymphocytic Leukemia

Interventions

DRUG

lenalidomide

Depending on the starting dose, subjects will be allocated in a double-blind fashion to three different regimens and will escalate every 28 days, based on individual subject tolerability, as follows: * Treatment Arm 1: 5 mg →10 mg →15 mg →20 mg →25 mg/daily * Treatment Arm 2: 10 mg →15 mg →20 mg →25 mg/daily * Treatment Arm 3: 15 mg →20 mg →25 mg/daily Subjects will continue treatment until disease progression or unacceptable toxicity

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Jeffery Jones, M.D., MPH · Celgene Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-19
Primary Completion
2017-09-05
Completion
2017-09-05

Countries

  • United States
  • Canada
  • France
  • Germany
  • Italy
  • Spain
  • Sweden
  • United Kingdom

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 NCT00963105 on ClinicalTrials.gov