Clinical Trial

Study of Valemetostat Tosylate as a Single Agent in Patients With Relapse/Refractory B-cell Lymphoma

Active, Not Recruiting Phase 2
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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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2021-04-09; most recent amendment 2026-02-17.
Status change: Recruiting → Active, Not Recruiting 2024-03-13
Status change: Not Yet Recruiting → Recruiting 2021-06-14
Trial Details
NCT Number NCT04842877
Lead Sponsor The Lymphoma Academic Research Organisation
Collaborators: Daiichi Sankyo
Conditions Lymphoma, B-Cell
Enrollment 141 participants
Start Date 2021-06-11
Primary Completion 2024-12-03 (estimated)
Study Completion 2026-10 (estimated)
Updated on ClinicalTrials.gov 2026-02-19