Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Clovis, California and other locations
Dates
study started
completion around

Description

Summary

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 will study 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 will 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.

Official Title

Symphony-1: A Phase 1b/3 Double-Blind, Randomized, Active-Controlled, 3-Stage, Biomarker Adaptive Study Of Tazemetostat Or Placebo In Combination With Lenalidomide Plus Rituximab In Subjects With Relapsed/Refractory Follicular Lymphoma

Details

Stage 1 is a safety run-in phase, was designed to evaluate the safety of the combination of tazemetostat and R2, as well as to establish the RP3D for Stage 2, which is now completed.

Stage 2 is an efficacy and safety phase for an assessment of the FL population with the enhancer of zeste homolog 2 (EZH2) gain-of-function (GOF) mutation (EZH2 mutant-type [MT]) and without the EZH2 GOF mutation (EZH2 wild-type [WT]). In Stage 2, EZH2 WT and EZH2 MT patients will be randomly assigned in a 1:1 ratio to tazemetostat + R2 or placebo + R2. There will be 1 futility interim analysis (IA) and 1 efficacy IA for WT population and 1 efficacy IA for MT population.

Stage 3 is a long-term follow-up of patients for assessment of response and overall survival. All patients will be followed for survival until 5 years post last patient enrolled in the study.

Keywords

Relapsed/Refractory Follicular Lymphoma, Follicular Lymphoma, Refractory Follicular Lymphoma, Epizyme, Tazverik, Tazemetostat (EPZ-6438), Lenalidomide, Revlimid, Rituximab, Rituxan, EZH2, Lymphoma, Tazemetostat

Eligibility

Locations

  • UCSF Fresno accepting new patients
    Clovis California 93611 United States
  • UCLA Clinical Research Unit Hematology/Oncology accepting new patients
    Santa Monica California 90404 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Epizyme, Inc.
ID
NCT04224493
Phase
Phase 3 Lymphoma Research Study
Study Type
Interventional
Participants
Expecting 612 study participants
Last Updated