NCT04762160

SYMPHONY-2, A Trial to Examine Combination of Tazemetostat With Rituximab in Subjects With Relapsed/Refractory Follicular Lymphoma

SYMPHONY-II: A Phase II Open-Label, Multicenter Trial of Oral Tazemetostat in Combination With Rituximab in Subjects With Relapsed/Refractory Follicular Lymphoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Epizyme, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the safety and efficacy of combining the EZH2 inhibitor tazemetostat with rituximab in R/R FL subjects previously treated with at least 2 standard prior systemic treatment regimens where at least 1 anti-CD20-based regimen was used.

Detailed description

This is a phase 2, multicenter, open-label study of oral tazemetostat in combination with rituximab in subjects with relapsed or refractory (R/R) follicular lymphoma (FL). This study is designed to evaluate the safety and efficacy of tazemetostat in combination with rituximab in subjects previously treated with at least 2 standard prior systemic treatment regimens where at least 1 anti-CD20-based regimen was used, and used and features early futility stopping to maintain subject safety.

Conditions

• Follicular Lymphoma

Interventions

Type	Name	Description
DRUG	Tazemetostat	Study Drug
COMBINATION_PRODUCT	Rituximab	Partner Drug

Timeline

• Start date: 2020-12-15
• Primary completion: 2022-03-22
• Completion: 2022-03-22
• First posted: 2021-02-21
• Last updated: 2024-03-25
• Results posted: 2023-11-21

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated drug study