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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to13 years
Awards & highlights
RELEVANCE Trial 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.Check my eligibility
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.See study design
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).
RELEVANCE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have not received any systemic treatment for lymphoma.
Select...
I have a tumor larger than 2 cm that has not been treated with radiation.
Select...
My condition is at stage II, III, or IV.
Select...
My lymphoma is CD20 positive and is grade 1, 2, or 3a.
Select...
I am 18 years or older and have signed an informed consent.
Select...
I can take care of myself but might not be able to do heavy physical work.
RELEVANCE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to13 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to13 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
COMPLETE RESPONSE RATE
Progression Free Survival (PFS)
Secondary outcome measures
Event Free Survival (EFS)
Health related quality of life as measured by the EORTC QLQ-C30
Number of participants with adverse events
+5 moreRELEVANCE 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
Find a Location
Who is running the clinical trial?
The Lymphoma Academic Research OrganisationLead Sponsor
55 Previous Clinical Trials
16,043 Total Patients Enrolled
Celgene CorporationIndustry Sponsor
444 Previous Clinical Trials
57,206 Total Patients Enrolled
Franck Morschhauser, MD, PhDStudy ChairThe Lymphoma Study Association (LYSA)
1 Previous Clinical Trials
255 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lymphoma has changed in its nature or is a specific aggressive type.I have not received any systemic treatment for lymphoma.I need treatment for my condition.I have a tumor larger than 2 cm that has not been treated with radiation.My condition is at stage II, III, or IV.I have been cancer-free from any cancer other than follicular lymphoma for over 10 years.My neuropathy is mild or I don't have it.My lymphoma has affected or previously affected my brain or spinal cord.I am 18 years or older and have signed an informed consent.I can take care of myself but might not be able to do heavy physical work.My blood counts are within normal ranges, not affected by cancer.I am at high risk for blood clots and unwilling to take preventive medication.My bilirubin levels are higher than 2.0 mg/dl, but it's due to Gilbert's Syndrome or liver lymphoma.My lymphoma is CD20 positive and is grade 1, 2, or 3a.I have not had major surgery in the last 28 days.My kidney function is low, with a creatinine clearance under 30 mL/min.I have previously taken lenalidomide.I have been on low-dose steroids, less than 10 mg/day of prednisone, for the last 4 weeks.My liver enzymes are more than three times the normal limit, but I don't have liver or pancreatic cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Lenalidomide + Rituximab
- Group 2: Control
Awards:
This trial has 4 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In how many different medical clinics is this research study being run today?
"12 patients are being enrolled for this trial at locations such as Fraser Valley Cancer Centre in Surrey, CHUM Hopital Notre-Dame in Montreal, and Sunnybrook Health Sciences Centre in Toronto."
Answered by AI
Has the FDA given lenalidomide the green light for use?
"Given that this is a Phase 3 trial with both efficacy and safety data, our team has Lenalidomide rated as a 3 in terms of risk."
Answered by AI
What is the primary purpose of Lenalidomide?
"Lenalidomide is often used to diffuse large b-cell lymphoma (dlbcl) and has been shown to be effective in other cases like at least two prior systemic chemotherapy regimens, b-cell lymphomas, polyangium."
Answered by AI
Can you list some prior research that has been done on Lenalidomide?
"Lenalidomide was first researched in 1993 at the National Institutes of Health Clinical Center. So far, 1174 studies have completed and 668 are ongoing with recruitment happening primarily in Surrey, British Columbia."
Answered by AI
How many test subjects are part of this clinical research?
"This particular clinical trial has completed patient recruitment. The study was initially posted on February 1st, 2012 and was most recently updated on August 18th, 2022. However, there are 1758 other trials actively enrolling participants with lymphoma and 668 trials for Lenalidomide that still need patients."
Answered by AI
Are new participants being sought for this clinical trial?
"This clinical trial is not currently recruiting patients. The original posting date was February 1, 2012, and the most recent edit was on August 18, 2022. However, there are 2426 other studies that are actively recruiting patients."
Answered by AI
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