Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Follicular

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Follicular Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Bendamustine Hydrochloride

Rituximab

Antineoplastic Agents, Immunological

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Phase 1:

90 mg/m\^2 of bendamustine by IV on Day 1 and 2 of a 28 day cycle (up to 3 Cycles)

375 mg/m\^2 of rituximab by IV on Day 1 of a 28 day cycle (up to 3 Cycles)

Participants enrolled in this phase will be given one of 3 different dose levels of tazemetostat along with the drugs above (for up to 3 Cycles). 3 patients will be assigned to the lowest dose level and if the dose is tolerated, 3 more patients will be enrolled one dose level higher. Up to 18 participants being enrolled.

Dose Level 1: 400 mg of tazemetostat orally twice daily

Dose Level 2: 600 mg of tazemetostat orally twice daily

Dose Level 3: 800 mg of tazemetostat orally twice daily

Phase 2:

6 patients from Phase 1 who were treated at the recommended Phase 2 dose will be added to 21 additional patients.

375 mg/m\^2 of rituximab through IV on Day 1 of a 28 day cycle (Cycles 1-6)

Tazemetostat orally twice daily of a 28 day cycle (Cycles 1-6)

Bendamustine

RP2D (400, 600, or 800 mg) orally twice daily Cycles 1-6

Tazemetostat

Vaishalee Kenkre, MD

Kimberly Cameron

Reem Karmali, MD

Kimberly Saulsberry

Carlos Galvez, MD

Kellie Harper

Andrew Evens, DO

Misty Fleming

Naren Epperla, MD

Jennifer Burken, MS

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.

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

Toxicity will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 5.0).

CMR will include complete metabolic response as defined by the Lugano classification.

Estimate the ORR after 3 cycles of BR plus tazemetostat. ORR (defined as CMR + PMR) as determined by the Lugano classification.

Estimate the CMR rate after 3 cycles of BR plus tazemetostat. CMR rate will include complete metabolic response as defined by the Lugano classification.

Evaluate DOR. DOR defined as the interval from response initiation (when either CMR or PMR is first determined) to progression or death, whichever occurs first. Metabolic response is defined by the Lugano classification.

Epizyme, Inc.

University of Wisconsin, Madison

Vaishalee Kenkre

Sponsor Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Tazemetostat With Rituximab and Abbreviated Bendamustine in the Frontline Treatment of High Tumor Burden Follicular Lymphoma	NCT05551936	Follicular Lymp...	Bendamustine Rituximab Tazemetostat	18 Years -	Big Ten Cancer Research Consortium
A Study of Tazemetostat With Rituximab and Abbreviated Bendamustine in the Frontline Treatment of High Tumor Burden Follicular Lymphoma	NCT05551936	Follicular Lymp...	Bendamustine Rituximab Tazemetostat	18 Years -	Big Ten Cancer Research Consortium

Spots Global Cancer Trial Database for high tumor burden