Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)

Relapsed/Refractory Peripheral T-Cell Lymphoma Clinical Trial

Official title: Single-arm, Phase 2 Study of Valemetostat Tosylate Monotherapy in Subjects With Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)

Status Active, not recruiting

Clinical Trial Summary

This study will characterize the safety and clinical benefit of valemetostat tosylate in participants with relapsed/refractory peripheral T-cell lymphoma, including relapsed/refractory adult T-cell leukemia/lymphoma.

Clinical Trial Description

This study was designed to evaluate the efficacy and safety of valemetostat tosylate monotherapy. The primary objective will evaluate objective response rate of valemetostat tosylate monotherapy as measured by blinded independent central review (BICR) in relapsed/refractory peripheral T-cell lymphoma. ;

Related Conditions & MeSH terms

• Adult T Cell Leukemia/Lymphoma
• Leukemia, T-Cell
• Leukemia-Lymphoma, Adult T-Cell
• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Relapsed/Refractory Peripheral T-Cell Lymphoma

• NCT number: NCT04703192
• Study type: Interventional
• Source: Daiichi Sankyo
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 3, 2021
• Completion date: September 8, 2025