Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)
2期
进行中（已停止招募）
NCT04703192
| 适应症 | Relapsed/Refractory Peripheral T-Cell Lymphoma, Adult T Cell Leukemia/Lymphoma |
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| 分期 | 2期 |
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| 申办方 | Daiichi Sankyo |
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| 状态 | 进行中（已停止招募） |
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| 受试者人数 | 155 人 |
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| 干预（药物） | Valemetostat Tosylate |
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| 开始日期 | 2021年6月3日 |
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| 完成日期 | 2023年5月10日 |
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| 结果公布日 | 2024年7月22日 |
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摘要
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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