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

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Trial Profile

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

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 08 Jan 2026

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At a glance

  • Drugs Valemetostat (Primary)
  • Indications Acute myeloid leukaemia; Adult T-cell leukaemia-lymphoma; Anaplastic large cell lymphoma; Cutaneous T-cell lymphoma; Follicular lymphoma; Peripheral T-cell lymphoma; T-cell lymphoma
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms VALENTINE-PTCL01
  • Sponsors Daiichi Sankyo Inc

Most Recent Events

  • 09 Dec 2025 Planned End Date changed from 8 Sep 2025 to 19 Feb 2027.
  • 02 Dec 2024 According to a Daiichi Sankyo Company media release, an exploratory analysis of circulating tumor DNA, a novel biomarker, to potentially predict clinical response to valemetostat from the VALENTINE-PTCL01 phase 2 trial in patients with relapsed or refractory peripheral T-cell lymphoma, was recently presented in The Lancet Oncology.
  • 02 Dec 2024 According to a Daiichi Sankyo Company media release, data from this trial will be presented in a Poster session on Monday, December 9, 6:00 - 8:00 pm at American Society of Hematology (#ASH24) Annual Meeting.

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