NCT04842877

A Phase II Open-label Study Evaluating Valemetostat Tosylate as a Single Agent in Patients With Relapse/Refractory B-cell Lymphoma

Active, enrolled Phase 2 Last updated 17 February 2026

What this trial tests

Phase 2 trial testing Valemetostat tosylate in Lymphoma, B-Cell in 141 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

11 June 2021

Primary endpoint
3 December 2024

1 October 2026

Quick facts

Lead sponsor	The Lymphoma Academic Research Organisation
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	141
Start date	11 June 2021
Primary completion	3 December 2024
Estimated completion	1 October 2026
Sites	22 locations across Belgium, France

Drugs / interventions tested

• Valemetostat tosylate — full drug profile →

Conditions studied

• Lymphoma, B-Cell — all drugs for Lymphoma, B-Cell →

Sponsor

The Lymphoma Academic Research Organisation — full company profile →

Who can join

18 and older, any sex, with Lymphoma, B-Cell. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Overall Response Rate (ORR)
  Time frame: when mature response rate data have been observed, estimated as no later than 12 months after the last patient in each cohort has received the first dose of study drug
  ORR according to Lugano Response Criteria (2014)

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The roles of EZH2 in cancer and its inhibitors.
   Liu Y, Yang Q. · · 2023 · cited 100× · PMID 37148376 · DOI 10.1007/s12032-023-02025-6
2. Epigenetic regulation in cancer.
   Gu M, Ren B, Fang Y, Ren J, et al · · 2024 · cited 54× · PMID 38374872 · DOI 10.1002/mco2.495
3. Valemetostat Tosilate: First Approval.
   Keam SJ. · · 2022 · cited 42× · PMID 36380144 · DOI 10.1007/s40265-022-01800-5
4. Pharmacological targeting of the cancer epigenome.
   Mabe NW, Perry JA, Malone CF, Stegmaier K. · · 2024 · cited 36× · PMID 38937652 · DOI 10.1038/s43018-024-00777-2
5. Relapsed/Refractory Diffuse Large B-Cell Lymphoma: A Look at the Approved and Emerging Therapies.
   Sawalha Y. · · 2021 · cited 25× · PMID 34945817 · DOI 10.3390/jpm11121345
6. H3K4 trimethylation regulates cancer immunity: a promising therapeutic target in combination with immunotherapy.
   Xiao C, Fan T, Zheng Y, Tian H, et al · · 2023 · cited 21× · PMID 37553181 · DOI 10.1136/jitc-2022-005693
7. The progress of novel strategies on immune-based therapy in relapsed or refractory diffuse large B-cell lymphoma.
   Lu T, Zhang J, Xu-Monette ZY, Young KH. · · 2023 · cited 19× · PMID 37580826 · DOI 10.1186/s40164-023-00432-z
8. Epigenetic, Metabolic, and Immune Crosstalk in Germinal-Center-Derived B-Cell Lymphomas: Unveiling New Vulnerabilities for Rational Combination Therapies.
   Serganova I, Chakraborty S, Yamshon S, Isshiki Y, et al · · 2021 · cited 19× · PMID 35071240 · DOI 10.3389/fcell.2021.805195