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Immunomodulatory Agent

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

Phase 2
Waitlist Available
Led By Danelle F James, M.D.
Research Sponsored by Chronic Lymphocytic Leukemia Research Consortium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Approved for 20 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

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.

Eligible Conditions
  • First-line Therapy
  • Frontline
  • First-Line Treatment
  • Chronic Lymphocytic Leukemia
  • Untreated

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: AActive Control1 Intervention
Subjects younger than 65 years old.
Group II: BActive Control1 Intervention
Subjects aged 65 years and older

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Who is running the clinical trial?

Celgene CorporationIndustry Sponsor
445 Previous Clinical Trials
58,566 Total Patients Enrolled
Chronic Lymphocytic Leukemia Research ConsortiumLead Sponsor
2 Previous Clinical Trials
181 Total Patients Enrolled
Thomas J Kipps, M.D., Ph.DStudy DirectorDirector of the CLL Research Consortium and University of California San Diego
Danelle F James, M.D.Principal InvestigatorCLL Research Consortium and University of California San Diego
~4 spots leftby Jan 2026
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