NCT05551936

A Study of Tazemetostat With Rituximab and Abbreviated Bendamustine in the Frontline Treatment of High Tumor Burden Follicular Lymphoma

A Single Arm Phase I/II Study of Tazemetostat With Rituximab and Abbreviated Bendamustine in the Frontline Treatment of High Tumor Burden Follicular Lymphoma Big Ten Cancer Research Consortium BTCRC-LYM20-463

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Vaishalee Kenkre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is planned as a single arm clinical trial of tazemetostat in combination with bendamustine and rituximab with both a phase I and phase II component. All patients will receive tazemetostat twice daily on days 1-28 in combination with bendamustine 90 mg/m2 IV on days 1 and 2 and rituximab 375 mg/m2 IV on day 1 of a 28-day cycle for up to three cycles. Following this, patients will receive tazemetostat twice daily on days 1-28 and rituximab 375 mg/m2 IV on day 1 of a 28-day cycle for up to three cycles.

Conditions

• Follicular Lymphoma

Interventions

Type	Name	Description
DRUG	Bendamustine	90 mg/m\^2 IV Days 1-2, Cycles 1-3
DRUG	Rituximab	375 mg/m\^2 IV Day 1 Cycles 1-6
DRUG	Tazemetostat	RP2D (400, 600, or 800 mg) orally twice daily Cycles 1-6

Timeline

• Start date: 2023-01-26
• Primary completion: 2026-05-01
• Completion: 2027-05-01
• First posted: 2022-09-23
• Last updated: 2026-02-17

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study