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NCT04224493 · ClinicalTrials.gov record · last posted 2026-08-10

A Study to Assess the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Tazemetostat in Combination With Lenalidomide Plus Rituximab Versus Placebo in Combination With Lenalidomide Plus Rituximab in Adult Patients at Least 18 Years of Age With Relapsed/Refractory Follicular Lymphoma.

Study acronym: SYMPHONY-1
StatusActive, Not Recruiting
PhasePhase 3
Started2020-06-11
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from the ClinicalTrials.gov record
The participants of this study would have relapsed/refractory follicular lymphoma. Follicular lymphoma is a type of blood cancer. It is referred to as 'relapsed' when the disease has come back after a period of improvement after that follows a treatment regimen and 'refractory' when treatment no longer works. Stage 1 of this trial studied the safety and the level that adverse effects of each of the study drug combinations can be tolerated (known as tolerability). It is also designed to establish a recommended study drug dosage for stage 2 and 3. Stage 1 of the study is completed. Stages 2 and 3 were designed to evaluate and compare how long participants live without their disease getting worse when receiving the study drug in combination with other drug treatment versus the placebo (dummy drug) in combination with other drug treatment. However, following an urgent safety measure, treatment with tazemetostat and placebo was discontinued, enrollment was stopped, and the study was unblinded. As a result, post-urgent safety measure analyses are descriptive in nature.

Protocol amendment history 4 changes detected by DataLookout

2026-08-11
Primary endpoint(s) modified
WasPFS in the Intent-to-treat mutant-type (ITT-MT) population, Progression-Free Survival (PFS) in the Intent-to-treat wild-type (ITT-WT) population, Recommended Phase 3 Dose (RP3D) of tazemetostat in combination with rituximab and lenalidomide (R2)
NowPhase 1b: Recommended Phase 3 Dose (RP3D) of tazemetostat in combination with rituximab and lenalidomide (R2), Phase 3: PFS in the Intent-to-treat mutant-type (ITT-MT) population, Phase 3: PFS in the R/R FL population regardless of mutation status by Investigator assessment, Phase 3: Progression-Free Survival (PFS) in the Intent-to-treat wild-type (ITT-WT) populations, Phase 3: Progression-Free Survival (PFS) in the all comer (ITT-All) populations.
2026-04-21
Trial status changed: Recruiting → Active, Not Recruiting
2026-04-21
Trial sites reduced: 229 → 204 locations
2026-04-21
Primary completion pushed: 2026-03-01 → 2027-02-13
Trial Details
NCT Number NCT04224493
Lead Sponsor Epizyme, Inc.
Conditions Relapsed/Refractory Follicular Lymphoma, Follicular Lymphoma, Refractory Follicular Lymphoma
Enrollment 599 participants
Start Date 2020-06-11
Primary Completion 2027-02-13 (estimated)
Study Completion 2029-03-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-10