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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to two years

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

Gastrointestinal intolerance

Impaired liver function test

100%

80%

60%

40%

20%

Study treatment Arm

Azathioprine

Rituximab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2990

Lenalidomide

2005

Completed Phase 3

~2240