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Immunomodulatory agent

Tazemetostat + Lenalidomide + Rituximab for Follicular Lymphoma (SYMPHONY-1 Trial)

Phase 3
Recruiting
Research Sponsored by Epizyme, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males or females are ≥18 years of age (≥20 years for Taiwan) at the time of providing voluntary written informed consent.
Adequate renal function defined as calculated creatinine clearance ≥30 mL/minute per the Cockcroft and Gault formula
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 72 months
Awards & highlights

SYMPHONY-1 Trial Summary

This trial is testing a new combination drug to treat people with a certain type of lymphoma who have not responded to other treatments. The trial will use biomarkers to select patients most likely to benefit from the new drug.

Who is the study for?
Adults with relapsed/refractory follicular lymphoma who've had prior treatments can join. They need good liver and kidney function, no major illnesses or brain metastases, not pregnant or breastfeeding, and must use effective contraception. Excluded are those with certain viral infections, recent major surgery, severe allergies to trial drugs, or taking specific medications.Check my eligibility
What is being tested?
The study tests Tazemetostat's effectiveness combined with Lenalidomide and Rituximab versus a placebo combination in improving survival without disease progression. Stage 1 focuses on safety and dosage; stages 2 and 3 compare the drug's efficacy against a placebo.See study design
What are the potential side effects?
Possible side effects include liver issues due to medication interactions, digestive problems that could affect drug absorption, blood disorders like anemia or clotting issues from bone marrow suppression, allergic reactions to the drugs used in treatment.

SYMPHONY-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am at least 18 years old, or 20 if I'm from Taiwan, and can give consent.
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My kidneys work well enough, with a creatinine clearance rate of at least 30 mL/min.
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I have had at least one treatment with chemotherapy, immunotherapy, or both.
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I have waited the required time after my last cancer treatment before starting tazemetostat.
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My cancer returned or didn't respond well to treatment.
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All my previous cancer treatment side effects are mild or stable now.
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I am using two reliable birth control methods or practicing abstinence.
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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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My lymphoma is confirmed to be Follicular Lymphoma, Grades 1 to 3A.

SYMPHONY-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 72 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 72 months 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)
Recommended Phase 3 Dose (RP3D) of tazemetostat in combination with rituximab and lenalidomide (R2)
Secondary outcome measures
Average Dose Intensity of Study Drug
Disease control rate (DCR)
Duration of Study Drug Exposure
+22 more

SYMPHONY-1 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Tazemetostat + R2 armExperimental Treatment3 Interventions
Stage 1 (Phase 1b): Tazemetostat will be escalated from a starting dose of 400 mg PO twice daily to 600 mg PO twice daily to 800 mg PO twice daily in 28-day cycles. Rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of cycle 1; then on day 1 of cycles 2 to 5. Lenalidomide 20 mg or 10 mg (if creatinine clearance ≥60 mL/minute or <60 mL/minute), administred PO QD on days 1 to 21 for 12 cycles. Stage 2 and Optional Stage 3 (Phase 3): Tazemetostat 800 mg administered PO twice daily in continuous 28-day cycles. Rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of cycle 1; then on day 1 of cycles 2 to 5. Lenalidomide 20 mg or 10 mg (if creatinine clearance ≥60 mL/minute or <60 mL/minute), PO QD on days 1 to 21 for 12 cycles. Maintenance Therapy (Stage 1, 2, and Optional Stage 3): Tazemetostat will be administered as monotherapy at an 800 mg twice daily dose for up to 2 years after the initial 12 months of combination therapy.
Group II: Placebo + R2 ArmPlacebo Group3 Interventions
Stage 2 and Optional Stage 3 (Phase 3): Placebo administered PO twice daily in continuous 28-day cycles. Rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of cycle 1; then on day 1 of cycles 2 to 5. Lenalidomide 20 mg or 10 mg (if creatinine clearance ≥60 mL/minute or <60 mL/minute), administered PO QD on days 1 to 21 for 12 cycles. Maintenance Therapy (Stage 1, 2, and Optional Stage 3): Placebo will be administered as monotherapy twice daily dose for up to 2 years after the initial 12 months of combination therapy. During maintenance, placebo will be continued until disease progression or unacceptable toxicity, or participant withdraws consent.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tazemetostat
2016
Completed Phase 2
~780
Lenalidomide
2005
Completed Phase 3
~1480
Rituximab
1999
Completed Phase 4
~1880

Find a Location

Who is running the clinical trial?

Epizyme, Inc.Lead Sponsor
33 Previous Clinical Trials
2,314 Total Patients Enrolled
Ipsen Medical DirectorStudy DirectorIpsen
257 Previous Clinical Trials
54,605 Total Patients Enrolled

Media Library

Lenalidomide (Immunomodulatory agent) Clinical Trial Eligibility Overview. Trial Name: NCT04224493 — Phase 3
Follicular Lymphoma Research Study Groups: Tazemetostat + R2 arm, Placebo + R2 Arm
Follicular Lymphoma Clinical Trial 2023: Lenalidomide Highlights & Side Effects. Trial Name: NCT04224493 — Phase 3
Lenalidomide (Immunomodulatory agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04224493 — Phase 3

Frequently Asked Questions

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

How many patients will be taking part in this clinical trial at most?

"In order to run this clinical trial, we need 540 willing and eligible patients. If you meet the specified inclusion criteria, you can participate in this trial from UCSF Fresno in Clovis, California or Centre Hospitalier de l'Universite de Montreal (CHUM) in Montréal, Quebec."

Answered by AI

Could you please provide an overview of the safety profile for Tazemetostat + R2 Arm?

"Tazemetostat + R2 Arm is considered safe because it has passed multiple rounds of testing with positive results."

Answered by AI

Are we still able to enroll people in this research project?

"The clinical trial, which was first advertised on December 19th 2019, is still recruiting patients according to the latest update from November 14th 2022 on clinicaltrials.gov"

Answered by AI

What do Tazemetostat + R2 Arm generally treat?

"Tazemetostat + R2 Arm has shown to be an effective treatment for chronic lymphocytic leukemia, diffuse large b-cell lymphoma (dlbcl), and patients that have undergone at least two prior systemic chemotherapy regimens."

Answered by AI

Are there numerous research centers located throughout Canada conducting this trial?

"To make things more convenient for test subjects, the 74 sites conducting this trial are located in or near Clovis, Montréal, East Brunswick and other cities."

Answered by AI

Could you please list any other times Tazemetostat has been studied in medical trials?

"Tazemetostat + R2 Arm was first studied in the year 1993 at National Institutes of Health Clinical Center, 9000 Rockville Pike. Since then there are 1177 completed studies. There are presently 645 actively recruiting trials, with many of these studies being performed out of Clovis, California."

Answered by AI

What are the goals of this clinical trial?

"The purpose of this research, which will take some time to complete, is to study Progression-free Survival (PFS). Additionally, the team hopes to understand disease control rate (DCR), overall survival (OS), and duration of complete response (DOCR)."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
65+
What site did they apply to?
UCLA Clinical Research Unit Hematology/Oncology
Assistant professor of medicine - Oncology
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Study of Tazemetostat Versus Placebo When Given in Combination With Lenalidomide and Rituximab in Participants With Relapsed/Refractory Follicular Lymphoma
2019. "Study of Tazemetostat Versus Placebo When Given in Combination With Lenalidomide and Rituximab in Participants With Relapsed/Refractory Follicular Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04224493.
All > Follicular Lymphoma
~161 spots leftby Mar 2026
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