drugset / Trial / NCT05551936
A Study of Tazemetostat With Rituximab and Abbreviated Bendamustine in the Frontline Treatment of High Tumor Burden Follicular Lymphoma
Phase 1/2
Active not recruiting
42 enrolled
Vaishalee Kenkre
Epizyme, Inc. · collabUniversity of Wisconsin, Madison · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2023-01-26
- Primary completion
- 2026-05
- Completion
- 2027-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bendamustine | Small molecule | 90 mg/m2 | Intravenous |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Subject | Tazemetostat | Small molecule | 400 mg | Oral |
| Subject | Tazemetostat | Small molecule | 600 mg | Oral |
| Subject | Tazemetostat | Small molecule | 800 mg | Oral |