BENITIONSClinical Trial Intelligence

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 질환Lymphoma
임상 단계2상
스폰서Takeda
상태진행 중(모집 완료)
참여자 수52 명
중재(약물)Brentuximab Vedotin, Cyclophosphamide, Doxorubicin, Prednisone
시작일2023년 2월 10일
완료일2025년 4월 27일
결과 공개일2026년 6월 12일

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 + CHP96.2 percentage of participants

Percentage of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE)

Up to approximately 7 months · percentage of participants

Brentuximab Vedotin + CHP100 percentage of participants

Number of Participants With Abnormal Changes From Baseline in Laboratory Measurements

Up to approximately 7 months · Participants

Brentuximab Vedotin + CHP1 Participants
Brentuximab Vedotin + CHP1 Participants
Brentuximab Vedotin + CHP1 Participants
Brentuximab Vedotin + CHP2 Participants
Brentuximab Vedotin + CHP2 Participants
Brentuximab Vedotin + CHP2 Participants

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