Clinical trialNCT00628238UnknownPhase 2Interventional

Multi-center Trial of Revlimid® and Rituximab, for First-Line Treatment of Chronic Lymphocytic Leukemia (CLL)

SponsorChronic Lymphocytic Leukemia Research ConsortiumEnrollment80CLLChronic Lymphocytic LeukemiaFirst-LineFront-lineInitial TherapyUntreated

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The study is a two-arm, multi-center trial of Revlimid® and Rituximab, for the frontline treatment of patients with Chronic Lymphocytic Leukemia (CLL) designed and conducted by the CLL Research Consortium (CRC). The purpose of this study is to determine the response rate of the combination of Revlimid® and Rituximab in previously untreated CLL patients in two arms- those aged 65 years and above and those younger than 65. Secondary objectives will evaluate the safety of the combination of Revlimid® and Rituximab, response duration, improvement in hematologic parameters, and the significance of the tumor flare reaction. All patients will have assessment of known prognostic factors for CLL as well as novel prognostic factors will be evaluated for predicting response to treatment. Biologic corollary studies are designed to evaluate the mechanism of Revlimid® in CLL and the combination of Revlimid® and Rituximab.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Danelle F James, M.D.
CLL Research Consortium and University of California San Diego
Principal Investigator
clinicaltrials.gov ↗
Thomas J Kipps, M.D., Ph.D
Director of the CLL Research Consortium and University of California San Diego
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

5 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of California San Diego
La Jolla, California, United States
Danelle F James, M.D.Thomas J Kipps, M.D., Ph.D.
Recruiting
Dana-Farber/harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States
Jennifer R Brown, M.D.,Ph.D
Recruiting
Long Island Jewish Medical Center
New Hyde Park, New York, United States
Kanti Rai, M.D.
Recruiting
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States
John Byrd, M.D.Michael Grever, M.D.Thomas Lin, M.D.
Not, yet, recruiting
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
Michael J Keating, M.D., B.S.William G Wierda, M.D., Ph.D.
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Lenalidomide and Rituximab

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 29 Feb 2008
Primary completion: 28 Feb 2011
Completion: 31 Jul 2011
Last update posted: 10 Sept 2010
Registered enrollment: 80
Registry id: NCT00628238

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.