drugset
drugset / Trial / NCT02889523

Study of Tazemetostat in Newly Diagnosed Diffuse Large B Cell and Follicular Lymphoma Patients Treated by Chemiotherapy

NCT02889523 ↗

Phase 1/2 Active not recruiting 214 enrolled The Lymphoma Academic Research Organisation Epizyme, Inc. · collab
Non-randomizedParallel-groupOpen-labelTreatment

Summary

Phase I of the study is designed to determine the recommended phase II dose (RP2D) for tazemetostat in patients treated with 8 cycles of R-CHOP 21. Phase II of the study is designed to determine the safety and the efficacy of tazemetostat in DLBCL and FL patients : DLBCL : tazemetostat with 6 cycles of R-CHOP 21 + 2 cycles of Rituximab FL : tazemetostat with 6 cycles of R-CHOP 21 + 2 cycles of Rituximab then maintenance with 6 months of tazemetostat and 24 months of Rituximab

Timeline

Start
2016-10
Primary completion
2023-01-31
Completion
2026-04

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Tazemetostat Small molecule 200 mg Oral
Subject Tazemetostat Small molecule 400 mg Oral
Subject Tazemetostat Small molecule 600 mg Oral
Subject Tazemetostat Small molecule 800 mg Oral
Background Cyclophosphamide Other / unclassified 750 mg/m2 Intravenous
Background Doxorubicin Other / unclassified 50 mg/m2 Intravenous
Background Prednisolone Other / unclassified 40 mg/m2 Oral
Background Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Background Vincristine Small molecule 1.4 mg/m2 Intravenous

Indications

diffuse large B-cell lymphoma follicular lymphoma