Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)
Phase 2
Active, not recruiting
NCT04703192
| Condition | Relapsed/Refractory Peripheral T-Cell Lymphoma, Adult T Cell Leukemia/Lymphoma |
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| Phase | Phase 2 |
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| Sponsor | Daiichi Sankyo |
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| Status | Active, not recruiting |
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| Enrollment | 155 participants |
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| Interventions | Valemetostat Tosylate |
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| Start date | Jun 3, 2021 |
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| Completion date | May 10, 2023 |
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| Results posted | Jul 22, 2024 |
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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.
Percentage of Participants With Objective Response As Assessed by Blinded Independent Central Review After Administration of Valemetostat Tosylate Monotherapy (Cohort 1)
From baseline until disease progression or death (whichever occurs first), up to approximately 23 months · percentage of participants
| Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL) | 43.7 percentage of participants |
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Number of Participants With Treatment-emergent Adverse Events After Administration of Valemetostat Tosylate Monotherapy (Cohort 2)
From the time the informed consent form is signed up to 30 days after last dose, up to 23 months · Participants
| Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma | 22 Participants |
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Open in BENITIONS
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