Study of Valemetostat Tosylate as a Single Agent in Patients With Relapse/Refractory B-cell Lymphoma
Status:
Recruiting
Trial end date:
2024-06-01
Target enrollment:
Participant gender:
Summary
This is a multicenter, prospective, single arm, non-randomized, open-label, phase 2 clinical
study to evaluate safety and efficacy of valemetostat tosylate (DS-3201b) in patients with
relapsed or refractory B cell lymphoma with 6 cohorts of patients including 2 biology-driven
cohorts. Up to 141 patients will be enrolled in 6 different cohorts (40 patients with
aggressive B-cell lymphoma, 41 with follicular lymphoma (FL), 20 with Mantle Cell Lymphoma
(MCL) and 20 with other indolent lymphomas, and 20 patients with Hodgkin lymphoma (HL)). FL
patients with EZH2 mutant (gain of function mutations) will be enrolled in the cohort 2bis.
At least 8 aggressive B-cell lymphoma patients with EZH2 mutant will be enrolled in the
cohort 1. The primary endpoint is the overall response rate (ORR) determined by investigator
assessment.