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Immunomodulatory Agent

Revlimid for Chronic Lymphocytic Leukemia

Phase 2

Waitlist Available

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

Study Summary

This trial is for patients with CLL who have relapsed or are refractory to treatment. The primary objective is to determine the overall response rate of the combination of Revlimid and rituximab.

Eligible Conditions

Chronic Lymphocytic Leukemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Response Rate (ORR)

Secondary outcome measures

Adverse Events to Study Treatment

Conversion of MRD-positive Complete Response or Partial Response (PR) to a MRD-negative Complete Response (CR) or Complete Response (CR) Respectively Following an Additional 6 Cycles of Revlimid Consolidation

Overall Survival

+2 more

Side effects data

From 2014 Phase 3 trial • 42 Patients • NCT01621672

68%

Grade 1 Hypoalbuminemia

52%

Grade 1 Thrombocytopenia

36%

Grade 2 Leukopenia

32%

Grade 1 Anemia

28%

Grade 1 Creatinine increase

24%

Grade 1 SGPT (ALT) increase

20%

Grade 1 Hyperglycemia

20%

Grade 2 Sensory/Neuropathy

20%

Grade 1 Hypokalemia

20%

Grade 1 SGOT (AST) increase

16%

Grade 1 Bilirubin increase

12%

Grade 2 Hypocalcemia

12%

Grade 4 Leukopenia

12%

Grade 1 Cough

12%

Grade 1 Diarrhea

12%

Grade 1 Alkaline phosphatase increase

Grade 2 Hypophosphatemia

Grade 1 Hyponatremia

Grade 2 Diarrhea

Grade 1 Joint

Grade 2 Hypothyroidism

Grade 3 Gait/ walking

Grade 3 Anemia

Grade 1 Sensory/Neuropathy

Grade 2 Upper Back

Grade 2 Creatinine increase

Grade 4 Thrombocyopenia

Grade 2 Hypoalbuminemia

Grade 1 Rhinitis

Grade 1 Fatigue

Grade 3 Dysphagia

Grade 3 Skin Rash/desquamation

Grade 3 Hypophosphatemia

Grade 4 Hypocalcemia

Grade 3 Hypokalemia

Grade 3 CNS Ischemia

Grade 3 Mood alteration

Grade 3 Sensory/Neuropathy

Grade 3 Extremity/limb

Grade 4 Neutropenia/granulocytopenia

Grade 3 Allergic reaction/Hypersensitivity

100%

80%

60%

40%

20%

Study treatment Arm

Revlimid

Observation

Trial Design

1Treatment groups

Experimental Treatment

Group I: Revlimid + RituximabExperimental Treatment2 Interventions

A: Lenalidomide starting at a low dose 2.5 or 5 mg, 21 days/cycle escalated based on patient tolerability. Rituximab at 375mg/m2 administered following the first 21 days of lenalidomide monotherapy, continued weekly throughout cycle 2, and then every 4 weeks for subsequent cycles (3-7). Each patient may receive up to 7 cycles of treatment with the combination lenalidomide/rituximab if no progressive disease or significant toxicity. Patients with residual disease can elect to receive 6 additional cycles of single agent Revlimid as consolidation. Each patient may receive up to a maximum of 13 cycles of treatment if no progressive disease or significant toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lenalidomide

FDA approved

Rituximab

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Celgene CorporationIndustry Sponsor

444 Previous Clinical Trials

58,206 Total Patients Enrolled

University of California, San DiegoLead Sponsor

1,119 Previous Clinical Trials

1,521,475 Total Patients Enrolled

Thomas J Kipps, MD, PhDStudy DirectorDirector of the CLL Research Consortium and University of California San Diego

1 Previous Clinical Trials

21 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of participants enrolled in this experiment?

"Unfortunately, no more applications are being accepted for this trial. It was initially posted on August 1st 2010 and the last edits were done on September 2nd 2021. Fortunately, there are presently 1522 experimental trials with leukemia as their focus actively recruiting participants and 609 clinical studies requiring Revlimid that are currently accepting candidates."

Answered by AI

What preventative measures are in place to ensure the security of Revlimid users?

"Revlimid has not yet passed Phase 3 clinical trials, so its safety is rated as a 2 because there are indications of efficacy but no evidence to support it."

Answered by AI

Is this trial still actively enrolling participants?

"As indicated by clinical trials.gov, this medical trial is no longer looking for applicants. It was initially posted on August 1st 2010 and last updated on September 2nd 2021; however there are still over 2000 studies actively recruiting volunteers at the moment."

Answered by AI

What primary illnesses is Revlimid employed to ameliorate?

"Revlimid is an approved therapeutic for DLBCL, B-cell lymphomas, and those who have previously received at least two systemic chemotherapy regimens."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase II Trial of Revlimid® and Rituximab for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

Thomas Kipps 2010. "Phase II Trial of Revlimid® and Rituximab for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01199575.