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Immunomodulatory Agent

Rituximab + Lenalidomide for Follicular Lymphoma (RELEVANCE Trial)

Phase 3

Waitlist Available

Research Sponsored by Celgene

Eligibility Criteria Checklist

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

Must have

Histologically confirmed follicular lymphoma grade 1, 2 or 3a, Stage II-IV

Symptomatic follicular lymphoma requiring treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 2.5 years

Awards & highlights

RELEVANCE Trial Summary

This trial will compare the effectiveness of the standard chemotherapy treatment for Follicular Lymphoma to a new combination treatment of lenalidomide and rituximab.

Who is the study for?

This trial is for adults with symptomatic follicular lymphoma grades 1, 2, or 3a at stages II-IV who haven't had systemic treatment. Participants should be able to perform daily activities (ECOG status 0-2) and agree to pregnancy precautions. Excluded are those allergic to murine products, with CNS lymphoma involvement, high VTE risk unwilling to take prophylaxis, certain lab abnormalities, transformed/Grade 3b lymphoma, recent major surgery or active hepatitis B/C or HIV.Check my eligibility

What is being tested?

The study tests the effectiveness of combining lenalidomide and rituximab in treating Follicular Lymphoma compared to standard chemo combinations like Rituximab-CVP/CHOP/Bendamustine. It aims to control the disease better and extend the period patients remain responsive without signs of progression.See study design

What are the potential side effects?

Potential side effects include reactions related to immune system activation such as infusion reactions from rituximab; blood cell count changes; fatigue; digestive issues from lenalidomide; increased risk of infections and possibly deep vein thrombosis due to heightened clotting tendency.

RELEVANCE Trial Eligibility Criteria

Inclusion Criteria

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

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My lymphoma is confirmed to be of a specific type and stage.

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I have symptoms from follicular lymphoma that need treatment.

Select...

I am 18 years old or older.

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I can take care of myself and am up and about more than half of my waking hours.

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I have not received any systemic treatment for lymphoma.

RELEVANCE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 2.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 2.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2.5 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Progression free survival (PFS)Follicular lymphoma

Secondary outcome measures

Complete Response Rate (CR/CRu) at 120 weeks

Event-Free Survival (EFS)

Health related quality of life as measured by the EORTC QLQ-C30 for Follicular Lymphoma patients

+8 more

RELEVANCE 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 for 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 up to 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 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor

636 Previous Clinical Trials

128,716 Total Patients Enrolled

The Lymphoma Academic Research OrganisationOTHER

55 Previous Clinical Trials

16,818 Total Patients Enrolled

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

1 Previous Clinical Trials

1,030 Total Patients Enrolled

Media Library

Lenalidomide (Immunomodulatory Agent) Clinical Trial Eligibility Overview. Trial Name: NCT01476787 — Phase 3

Follicular Lymphoma Research Study Groups: Lenalidomide + Rituximab, Control

Follicular Lymphoma Clinical Trial 2023: Lenalidomide Highlights & Side Effects. Trial Name: NCT01476787 — Phase 3

Lenalidomide (Immunomodulatory Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01476787 — Phase 3

Frequently Asked Questions

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

What is the FDA's opinion on Lenalidomide?

"Lenalidomide has undergone Phase 3 trials, which is the gold standard for demonstrating a medication's efficacy and safety. Thus, we rate Lenalidomide as having a score of 3 in terms of safety."

Answered by AI

What are the main reasons that doctors prescribe Lenalidomide?

"Lenalidomide is often used to diffuse large b-cell lymphoma (DLBCL), but can also be effective against certain other conditions like B-cell lymphomas and polyangiitis."

Answered by AI

Are people still being recruited for this experiment?

"Unfortunately, this study is not presently enrolling new patients. The trial was initially posted on 12/29/2011 and was last updated on 1/8/2021. However, there are 1758 other trials for lymphoma and 668 involving Lenalidomide that are actively recruiting participants."

Answered by AI

In how many different geographical areas is this trial taking place?

"Presently, potential enrollees can choose from 36 different participating clinical sites. While Boston, Hazard and Omaha are a few of the locations, there are many other options too. If you enroll in this study, it will be most convenient for you if select a location that is near to where you live to limit travel requirements."

Answered by AI

How many people are being signed up for this experiment?

"As of right now, this trial is not recruiting any more participants. The study was first posted on December 29th 2011 and updated January 8th 2021. There are currently 1758 trials actively searching for patients with lymphoma and 668 trials for Lenalidomide that are actively looking for patients."

Answered by AI

What is the scientific community's previous experience with Lenalidomide?

"Lenalidomide was first studied at the National Institutes of Health Clinical Center in 1993. So far, 1174 clinical trials have been completed with 668 live studies currently underway; a significant portion of these are based in Boston, MA."

Answered by AI

Recent research and studies

New England Journal of MedicineJournal

Rituximab Plus Lenalidomide in Advanced Untreated Follicular Lymphoma

Morschhauser, Franck, Nathan H. Fowler, Pierre Feugier, Reda Bouabdallah, Hervé Tilly, M. Lia Palomba, Christophe Fruchart, et al.. 2018. “Rituximab Plus Lenalidomide in Advanced Untreated Follicular Lymphoma”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1805104.

The Lancet OncologyJournal

Safety and Activity of Lenalidomide and Rituximab in Untreated Indolent Lymphoma: An Open-label, Phase 2 Trial

Fowler, Nathan H, R Eric Davis, Seema Rawal, Loretta Nastoupil, Fredrick B Hagemeister, Peter McLaughlin, Larry W Kwak, et al.. 2014. “Safety and Activity of Lenalidomide and Rituximab in Untreated Indolent Lymphoma: An Open-label, Phase 2 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(14)70455-3.

CancerJournal

Combined Lenalidomide, Low-dose Dexamethasone, and Rituximab Achieves Durable Responses in Rituximab-resistant Indolent and Mantle Cell Lymphomas

Ahmadi, Tahamtan, Elise A. Chong, Amanda Gordon, Nicole A. Aqui, Sunita D. Nasta, Jakub Svoboda, Anthony R. Mato, and Stephen J. Schuster. 2013. “Combined Lenalidomide, Low-dose Dexamethasone, and Rituximab Achieves Durable Responses in Rituximab-resistant Indolent and Mantle Cell Lymphomas”. Cancer. Wiley. doi:10.1002/cncr.28405.

Blood AdvancesJournal