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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Vaishalee Kenkre
Study ID
NCT05551936
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 26, 2023
Status verified
Feb 2026
Primary completion
May 31, 2026
Completion
May 31, 2027

Study Design

Enrollment
42 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Investigational Group
    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)

Primary Outcome Measure

Phase I: Evaluate safety and tolerability of tazemetostat with bendamustine and rituximab (BR) [ Time Frame: 6 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611-
University of Illinois Cancer CenterChicagoIllinois60612-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
University of Wisconsin Carbone Cancer CenterMadisonWisconsin53705-

Find similar trials in Chicago, IL

By research site
Northwestern University· Chicago, ILUniversity of Illinois Cancer Center· Chicago, ILRutgers Cancer Institute of New Jersey· New Brunswick, NJOhio State University Comprehensive Cancer Center· Columbus, OHUniversity of Wisconsin Carbone Cancer Center· Madison, WI

Related Studies