Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)
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Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
155actual
Sites
60
Countries
Australia, Canada, France +9
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-06-03 | actual | When the study began enrolling |
| Primary completion | 2023-05-10 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-08-31 | estimated | The whole study's end, after follow-up |
| First posted | 2021-01-11 | actual | When this record first appeared on the registry |
| Results posted | 2024-07-22 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-07-20 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Relapsed/Refractory Peripheral T-Cell Lymphoma
- Adult T Cell Leukemia/Lymphoma
Intervention
- Drug: Valemetostat Tosylate — also filed as DS-3201b
Primary outcomes
what the primary-completion date above is the date OFPercentage of Participants With Objective Response As Assessed by Blinded Independent Central Review After Administration of Valemetostat Tosylate Monotherapy (Cohort 1)
measured From baseline until disease progression or death (whichever occurs first), up to approximately 23 months
Number of Participants With Treatment-emergent Adverse Events After Administration of Valemetostat Tosylate Monotherapy (Cohort 2)
measured From the time the informed consent form is signed up to 30 days after last dose, up to 23 months
Posted documents
hosted by the registry — we link, never re-serveStudy Protocol and Statistical Analysis Planposted 2022-09-09 · 5.6 MB · Prot_SAP_000.pdf
Publications
- PMID 39486433 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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