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)
2상
진행 중(모집 완료)
NCT05673785
| 대상 질환 | Lymphoma |
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| 임상 단계 | 2상 |
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| 스폰서 | Takeda |
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| 상태 | 진행 중(모집 완료) |
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| 참여자 수 | 52 명 |
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| 중재(약물) | Brentuximab Vedotin, Cyclophosphamide, Doxorubicin, Prednisone |
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| 시작일 | 2023년 2월 10일 |
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| 완료일 | 2025년 4월 27일 |
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| 결과 공개일 | 2026년 6월 12일 |
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요약
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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