CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 317 enrolled
Drug / intervention
Lenalidomide +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00774345
NCT00774345Phase 3Completed

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Lenalidomide (Revlimid®) as Maintenance Therapy for Patients With B-Cell Chronic Lymphocytic Leukemia Following Second-Line Therapy (The Continuum Trial)

Celgene·interventional·Posted Oct 17, 2008·Updated Dec 2, 2021

In Brief

A Phase 3 clinical trial evaluating Lenalidomide and Placebo for B-cell Chronic Lymphocytic Leukemia. Completed, enrolled 317 participants across 241 sites in 25 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, 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, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 17, 2008
Enrollment StartJan 27, 2009
Primary CompletionOct 27, 2020
TodayJul 2, 2026
Enrollment to primary: 11.8 yearsPosted 17.7 years ago

Interventions

Lenalidomidedrug

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

Placebodrug

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