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Immunomodulatory Agent

Rituximab + Lenalidomide for Follicular Lymphoma (RELEVANCE Trial)

Phase 3

Waitlist Available

Research Sponsored by The Lymphoma Academic Research Organisation

Eligibility Criteria Checklist

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

Must have

Have no prior systemic treatment for lymphoma

Bi-dimensionally measurable disease with at least one mass lesion > 2 cm that was not previously irradiated

Must not have

Clinical evidence of transformed lymphoma by investigator assessment or Grade 3b follicular lymphoma

Neuropathy > Grade 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 13 years

Awards & highlights

Summary

This trial tests if adding lenalidomide to rituximab helps control disease and increase response length compared to standard rituximab chemotherapy.

Who is the study for?

This trial is for adults with previously untreated CD20+ follicular lymphoma grades 1, 2, or 3a. Participants must have a performance status ≤2 on the ECOG scale, measurable disease over 2 cm, and stage II-IV disease. They should not have other malignancies within the last ten years or conditions that risk their safety in the study.

What is being tested?

The study compares Rituximab combined with Lenalidomide against Rituximab plus standard chemotherapy followed by maintenance Rituximab to see which is more effective at controlling follicular lymphoma and prolonging patient response.

What are the potential side effects?

Possible side effects include allergic reactions to treatment components (especially murine products), blood disorders due to bone marrow involvement, increased risk of infections like hepatitis B/C or HIV if already present, and potential nerve damage (neuropathy).

Eligibility Criteria

Inclusion Criteria

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

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I have not received any systemic treatment for lymphoma.

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I have a tumor larger than 2 cm that has not been treated with radiation.

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My condition is at stage II, III, or IV.

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My lymphoma is CD20 positive and is grade 1, 2, or 3a.

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I am 18 years or older and have signed an informed consent.

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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My lymphoma has changed in its nature or is a specific aggressive type.

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My neuropathy is mild or I don't have it.

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My lymphoma has affected or previously affected my brain or spinal cord.

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I am at high risk for blood clots and unwilling to take preventive medication.

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I have not had major surgery in the last 28 days.

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My kidney function is low, with a creatinine clearance under 30 mL/min.

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I have previously taken lenalidomide.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 13 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 13 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 13 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

COMPLETE RESPONSE RATE

Progression Free Survival (PFS)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Lenalidomide + RituximabExperimental Treatment2 Interventions

* Lenalidomide dose 20-mg on days 2-22 every 28 days x 6 cycles, if CR then 10-mg on days 2-22 every 28 days for 12 cycles. PR after 6 cycles, continue 20 mg for 3\~6 cycles and then 10 mg on days 2-22 every 28-day cycles for upto 18 cycles * Rituximab, 375 mg/m2 on days 1, 8, 15 and 22 of cycle 1, day 1 of cycles 2 to 6; 8 weeks later responding patients continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.

Group II: ControlActive Control3 Interventions

• ONE of the following: Rituximab - CHOP, Rituximab - CVP, Rituximab - Bendamustine. 7 to 8 weeks later responding patients will continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

FDA approved

Lenalidomide

FDA approved

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Lymphoma Academic Research OrganisationLead Sponsor

56 Previous Clinical Trials

16,143 Total Patients Enrolled

Celgene CorporationIndustry Sponsor

444 Previous Clinical Trials

57,207 Total Patients Enrolled

Franck Morschhauser, MD, PhDStudy ChairThe Lymphoma Study Association (LYSA)

1 Previous Clinical Trials

255 Total Patients Enrolled

Media Library

Lenalidomide (Immunomodulatory Agent) Clinical Trial Eligibility Overview. Trial Name: NCT01650701 — Phase 3

Follicular Lymphoma Research Study Groups: Lenalidomide + Rituximab, Control

Follicular Lymphoma Clinical Trial 2023: Lenalidomide Highlights & Side Effects. Trial Name: NCT01650701 — Phase 3

Lenalidomide (Immunomodulatory Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01650701 — Phase 3

~76 spots leftby Sep 2025

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