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A Study to Evaluate the Efficacy and Safety of Lenalidomide as Maintenance Therapy for Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Following Second Line Therapy

NCT00774345 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 317

Last updated 2021-12-02

Study results available
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Summary

The purpose of this study is to determine if lenalidomide (Revlimid®) is safe and effective as a maintenance therapy at improving further the quality of the response you achieved with your last therapy and at prolonging the duration of your response. This study will compare the effects (good and bad) of lenalidomide with the dummy drug.

Conditions

  • B-cell Chronic Lymphocytic Leukemia

Interventions

DRUG

Lenalidomide

Lenalidomide capsules given orally on days 1-28 of a 28 day cycle

DRUG

Placebo

Placebo capsules given orally on days 1 - 28 of a 28 day cycle

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Richard Delarue, MD · 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
2009-01-27
Primary Completion
2020-10-27
Completion
2020-10-27

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Colombia
  • Czechia
  • Denmark
  • France
  • Germany
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Mexico
  • Netherlands
  • New Zealand
  • Poland
  • Portugal
  • Romania
  • Russia
  • South Africa
  • 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 NCT00774345 on ClinicalTrials.gov