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Immunomodulatory Agent

A for Chronic Lymphocytic Leukemia

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
Diagnosis of chronic lymphocytic leukemia with no history of previous treatments with monoclonal antibodies or chemotherapy.
Subjects must have an indication for treatment as defined by the NCI Working Group Guidelines
Timeline
Screening 3 weeks
Treatment Varies
Follow Up clinical response assessment after 3 cycles of therapy and 3 months following completion of all therapy for nci-cll working group response assessment
Awards & highlights

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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~clinical response assessment after 3 cycles of therapy and 3 months following completion of all therapy for nci-cll working group response assessment
This trial's timeline: 3 weeks for screening, Varies for treatment, and clinical response assessment after 3 cycles of therapy and 3 months following completion of all therapy for nci-cll working group response assessment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy to be assessed by clinical response rate following 3 cycles of treatment and the NCI-CLL working group response rate assessed after completion of all treatment.
Secondary outcome measures
Compare the efficacy and tolerability of the combination of Revlimid and rituximab for patients younger than 65 years, and for those 65 and older. •
Evaluate change in hematological parameters including neutropenia, anemia, and thrombocytopenia following treatment with the combination of Revlimid and rituximab.
Evaluate response to lenalidomide in relationship to molecular and genetic prognostic features in CLL; including ZAP-70 status, IgVH gene mutational status, and FISH.
+2 more

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

Find a Location

Who is running the clinical trial?

Celgene CorporationIndustry Sponsor
444 Previous Clinical Trials
58,355 Total Patients Enrolled
Chronic Lymphocytic Leukemia Research ConsortiumLead Sponsor
2 Previous Clinical Trials
181 Total Patients Enrolled
Danelle F James, M.D.Principal InvestigatorCLL Research Consortium and University of California San Diego

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~5 spots leftby Mar 2025