A Study of Brentuximab Vedotin in Combination With Cyclophosphamide, Doxorubicin (Hydroxydaunorubicin), Prednisone (CHP) in Chinese Participants With CD30-Positive (CD30+) Peripheral T-Cell Lymphomas (PTCL)
2期
进行中(已停止招募)
NCT05673785
| 适应症 | Lymphoma |
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| 分期 | 2期 |
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| 申办方 | Takeda |
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| 状态 | 进行中(已停止招募) |
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| 受试者人数 | 52 人 |
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| 干预(药物) | Brentuximab Vedotin, Cyclophosphamide, Doxorubicin, Prednisone |
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| 开始日期 | 2023年2月10日 |
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| 完成日期 | 2025年4月27日 |
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| 结果公布日 | 2026年6月12日 |
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摘要
This study will use a combination of Brentuximab vedotin with CHP to treat adult Chinese participants with CD30+ PTCL. The main aims of the study are to evaluate: * Side effect from the A+CHP * Check how much A+CHP stays in their blood over time. This will help Takeda to work out the best dose to give people in the future. * If A+CHP improves outcome of newly diagnosed CD30+ PTCL Brentuximab vedotin will be given through vein on Day 1 of each 21-day cycle. Cyclophosphamide and doxorubicin will be given through vein. Prednisone will be given orally daily on Days 1 through 5.
Overall Response Rate (ORR) by Independent Review Facility (IRF) Assessment Per Revised Response Criteria for Malignant Lymphoma
Up to approximately 7 months · percentage of participants
| Brentuximab Vedotin + CHP | 96.2 percentage of participants |
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Percentage of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE)
Up to approximately 7 months · percentage of participants
| Brentuximab Vedotin + CHP | 100 percentage of participants |
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Number of Participants With Abnormal Changes From Baseline in Laboratory Measurements
Up to approximately 7 months · Participants
| Brentuximab Vedotin + CHP | 1 Participants |
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| Brentuximab Vedotin + CHP | 1 Participants |
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| Brentuximab Vedotin + CHP | 1 Participants |
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| Brentuximab Vedotin + CHP | 2 Participants |
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| Brentuximab Vedotin + CHP | 2 Participants |
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| Brentuximab Vedotin + CHP | 2 Participants |
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