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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)
Sponsor: Takeda
Summary
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.
Official title: A Phase 2, Single-Arm, Open-Label, Multicenter Study of Brentuximab Vedotin in Combination With Cyclophosphamide, Doxorubicin (Hydroxydaunorubicin), Prednisone (CHP) in the Frontline Treatment of Chinese Patients With CD30-Positive (CD30+) Peripheral T-Cell Lymphomas (PTCL)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
52
Start Date
2023-02-10
Completion Date
2027-12-31
Last Updated
2025-07-14
Healthy Volunteers
No
Conditions
Interventions
Brentuximab Vedotin
Brentuximab vedotin IV infusion
Cyclophosphamide
Cyclophosphamide IV infusion
Doxorubicin
Doxorubicin IV infusion
Prednisone
Prednisone tablets
Locations (16)
Beijing Cancer Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
The First Hospital of Jilin University
Changchun, China
West China Hospital, Sichuan University
Chengdu, China
Chongqing University Cancer Hospital
Chongqing, China
Fujian Medical University Union Hospital
Fuzhou, China
Guangdong Provincial Peoples Hospital
Guangzhou, China
The First Affiliated Hospital of Zhejiang University school of medicine
Hangzhou, China
Anhui Provincial Cancer Hospital
Hefei, China
Shandong Cancer Hospital
Jinan, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
Fudan University Shanghai Cancer Center
Shanghai, China
Shengjing Hospital of China Medical University
Shenyang, China
The First Affiliated Hospital of Soochow University
Suzhou, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
Henan Cancer Hospital
Zhengzhou, China