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

NCT05551936 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-02-17

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Epizyme, Inc.

    collaborator INDUSTRY

  • University of Wisconsin, Madison

    collaborator OTHER

  • Vaishalee Kenkre

    lead OTHER

Principal Investigators

  • Vaishalee Kenkre, MD · University of Wisconsin, Madison

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-26
Primary Completion
2026-05-31
Completion
2027-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05551936 on ClinicalTrials.gov