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Lenalidomide + Rituximab for Non-Hodgkin's Lymphoma (MAGNIFY 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
Eastern Cooperative Oncology Group (ECOG) Performance status < 2
Age ≥18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
MAGNIFY Trial Summary
This trial is testing the combination of lenalidomide and rituximab to see if it is more effective in treating NHL than lenalidomide alone.
Who is the study for?
Adults with certain types of B-cell Non-Hodgkin's Lymphoma, specifically Follicular, Marginal Zone or Mantle Cell Lymphoma that has returned or didn't respond to treatment. Participants need measurable disease, good performance status (<2), and adequate bone marrow function. They must not have used lymphoma therapy recently and should agree to pregnancy precautions.Check my eligibility
What is being tested?
The trial is testing the effectiveness of Lenalidomide combined with Rituximab (R2) against these lymphomas compared to using Rituximab alone for maintenance. It explores whether R2 can improve outcomes in patients whose disease has relapsed or is refractory.See study design
What are the potential side effects?
Lenalidomide may cause blood clots, fatigue, diarrhea, itching/rash; while Rituximab could lead to infusion reactions like fever/chills, infections risk increase due to low white blood cells count and potential heart issues.
MAGNIFY Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can do all or most of my daily activities without help.
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I am 18 years old or older.
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My cancer has returned or worsened after my last treatment.
Select...
My diagnosis is a specific type of lymphoma.
MAGNIFY Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
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) for Follicular lymphoma (FL), marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL)
Secondary outcome measures
Adverse Events
Complete response rate
Duration of complete response
+6 moreMAGNIFY Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A: Lenalidomide + rituximab followed by lenalidomideExperimental Treatment2 Interventions
Induction Period (12 cycles): Lenalidomide 20mg (10 mg if creatinine clearance ≥ 30 mL/min but < 60mL/min) by mouth (PO) daily (QD) on Days 1 to 21 of every 28-day cycle during cycles 1 through 12 and rituximab 375mg/m^2 intraveneously (IV) every week in Cycle 1 on Days 1, 8, 15, and 22 and on Day 1 of every 28-day cycle during cycles 3, 5, 7, 9, and 11, followed by a Maintenance Period (lasting 18 Cycles) that includes Lenalidomide 10 mg PO QD on Days 1 to 21 of every 28-day cycle during cycles 13 to 30 and rituximab 375 mg/m^2 IV on Day 1 of every 28-day cycle during cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29 followed by an optional Maintenance Period (up to Progressive Disease) receiving Lenalidomide 10mg PO QD on Days 1 through 21 of every 28 day cycle until the disease progresses
Group II: Arm B: Lenalidomide + rituximab followed by rituximabActive Control2 Interventions
Induction Period (12 Cycles): Lenalidomide 20 mg PO QD (10 mg if creatinine clearance ≥ 30 mL/min but < 60 mL/min) on Days 1 to 21 of every 28-day cycle during cycles 1 to 12 and rituximab 375 mg/m^2 IV every week in cycle 1 on Days 1, 8, 15, and 22 and on Day 1 of every 28-day cycle during cycles 3, 5, 7, 9, and 11, followed by a Maintenance Period for 18 Cycles that includes: Rituximab 375 mg/m^2 IV on Day 1 of every 28-day cycle during cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
2005
Completed Phase 3
~1480
Rituximab
1999
Completed Phase 4
~1880
Find a Location
Who is running the clinical trial?
CelgeneLead Sponsor
636 Previous Clinical Trials
128,468 Total Patients Enrolled
Mecide Gharibo, MDStudy DirectorCelgene
2 Previous Clinical Trials
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,506 Previous Clinical Trials
3,369,027 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on long-term steroids for a condition other than lymphoma.My lymphoma is not follicular, marginal zone, or Grade 3b.I can do all or most of my daily activities without help.I have taken less than 20 mg/day of prednisone or equivalent in the last week.I haven't had lymphoma treatment or used antibody agents in the last 4 weeks.My lymphoma has affected or previously affected my brain or spinal cord.I am 18 years old or older.I am at risk for blood clots and refuse to take preventive medication.My cancer has returned or worsened after my last treatment.My bone marrow is working well.My diagnosis is a specific type of lymphoma.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: Lenalidomide + rituximab followed by lenalidomide
- Group 2: Arm B: Lenalidomide + rituximab followed by rituximab
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Is this study still enrolling new participants?
"Data from clinicaltrials.gov suggests that this particular trial is not currently recruiting patients. The study was initially posted on April 1st, 2014 but was last edited on October 25th, 2020. There are 2419 other trials seeking patients at the moment."
Answered by AI
Are there any dangers associated with Rituximab?
"There is some clinical evidence in support of Rituximab's efficacy, as well as multiple rounds of safety data, so it received a score of 3."
Answered by AI
What is the general research consensus on Rituximab's effectiveness?
"Rituximab was first studied in 1993 at National Institutes of Health Clinical Center. So far, there have been 1105 completed studies with 628 trials actively recruiting patients. Many of these locations are based out of Park Ridge, Illinois."
Answered by AI
What are some of Rituximab's primary functions?
"Rituximab is most often used to treat diffuse large b-cell lymphoma (dlbcl), however, it has also been found effective in treating other conditions such as at least two prior systemic chemotherapy regimens, b-cell lymphomas, and polyangium."
Answered by AI
How many individuals are involved in this clinical trial?
"This particular study is no longer looking for volunteers. It was originally posted on April 1st, 2014 but has not been updated since October 25th, 2022. However, there are currently 1791 trials actively recruiting participants with lymphoma and 628 trials involving Rituximab that are still admitting patients."
Answered by AI
Can you tell me how many different hospitals are participating in this clinical trial?
"There are 100 sites participating in this study, including Oncology Specialists, PC in Park Ridge, Sparrow Hospital and Health System in Lansing, Local Institution - 050 in Bolivar, and other locations."
Answered by AI
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