Vaishali Kenkare
Vaishali Kenkare
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.
Follicular Lymphoma
Bendamustine
Rituximab
Tazemetostat
Phase 1
Phase 2
Study Type : | Interventional |
Estimated Enrollment : | 42 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | 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 |
Actual Study Start Date : | January 26, 2023 |
Estimated Primary Completion Date : | May 2024 |
Estimated Study Completion Date : | May 2025 |
Arm | Intervention/treatment |
---|---|
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) |
Drug: Bendamustine Drug: Rituximab Other: Tazemetostat |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612
Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Recruiting
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53705