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Immunomodulatory Agent

Lenalidomide + Rituximab for Lymphoma

Phase 2
Waitlist Available
Led By Joseph M. Tuscano, MD
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Relapsed or refractory disease
Evidence of disease progression during or after last treatment
Must not have
CNS metastases
Development of erythema nodosum characterized by a desquamating rash while taking thalidomide or similar drugs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to two years
Awards & highlights

Summary

This trial is studying lenalidomide and rituximab to see how well they work compared with rituximab in treating patients with follicular or small lymphocytic lymphoma.

Who is the study for?
This trial is for patients with specific types of non-Hodgkin lymphoma that have relapsed or didn't respond to treatment. Participants should be relatively healthy, not pregnant, and without serious recent cancers or neuropathy. They must have at least one measurable lesion and no CNS metastases, a decent performance status (ECOG 0-2), acceptable blood counts, organ function, and agree to use effective contraception.
What is being tested?
The study tests the combination of lenalidomide (a drug that may stimulate the immune system) with rituximab (an antibody that blocks cancer growth) in treating lymphoma. It's a phase II trial aimed at seeing how well this combo works against follicular or small lymphocytic non-Hodgkin lymphoma after other treatments failed.
What are the potential side effects?
Lenalidomide can cause side effects like fatigue, diarrhea, rash or itching; it might also affect blood cell counts leading to higher infection risk. Rituximab could cause infusion reactions such as fever and chills, body aches, tiredness; rarely severe skin reactions or heart problems may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition has returned or didn't respond to treatment.
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My condition worsened during or after my last treatment.
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I can take daily aspirin or low molecular weight heparin.
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I do not have severe nerve pain or numbness.
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I haven't had skin reactions from thalidomide or similar medications.
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I do not have active hepatitis A, B, or C.
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I can swallow lenalidomide pills.
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I can take care of myself and am up and about more than half of the day.
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My condition is a specific type of non-Hodgkin lymphoma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has spread to my brain.
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I developed a peeling rash from thalidomide or similar drugs.
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I am not currently receiving any cancer treatments like radiotherapy or thalidomide.
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I am currently receiving sargramostim treatment.
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I do not have any serious health issues that would stop me from joining the study.
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I have previously taken lenalidomide.
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I am currently receiving treatment for lymphoma, including steroids for allergic reactions.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Response, as defined by complete response (CR), near CR, partial response, or stable disease at 4 months
Secondary study objectives
Duration of response
Overall survival
Time to disease progression

Side effects data

From 2016 Phase 2 & 3 trial • 86 Patients • NCT03002038
4%
Gastrointestinal intolerance
2%
Impaired liver function test
100%
80%
60%
40%
20%
0%
Study treatment Arm
Azathioprine
Rituximab

Trial Design

1Treatment groups
Experimental Treatment
Group I: Lenalidomide and RituximabExperimental Treatment2 Interventions
Rituximab 375 mg/m2/wk x 4 weeks, to begin Cycle 1, Day 15. Lenalidomide 20 mg daily, days 1-21 of a 28 day cycle, to begin Day 1 of cycle 1 and continue until disease progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~2200
Lenalidomide
2005
Completed Phase 3
~1340

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor
928 Previous Clinical Trials
4,720,988 Total Patients Enrolled
9 Trials studying Lymphoma
735 Patients Enrolled for Lymphoma
CelgeneIndustry Sponsor
645 Previous Clinical Trials
130,519 Total Patients Enrolled
88 Trials studying Lymphoma
9,841 Patients Enrolled for Lymphoma
Joseph M. Tuscano, MDPrincipal InvestigatorUniversity of California, Davis

Media Library

Lenalidomide (Immunomodulatory Agent) Clinical Trial Eligibility Overview. Trial Name: NCT00848328 — Phase 2
Lymphoma Research Study Groups: Lenalidomide and Rituximab
Lymphoma Clinical Trial 2023: Lenalidomide Highlights & Side Effects. Trial Name: NCT00848328 — Phase 2
Lenalidomide (Immunomodulatory Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00848328 — Phase 2
~2 spots leftby Sep 2025
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