Spots Global Cancer Trial Database for 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)
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Trial Identification
Brief Title: 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)
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)
Study ID: NCT05673785
Conditions
Study Description
Brief 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.
Detailed Description: The drug being tested in this study is called brentuximab vedotin. Brentuximab vedotin is being tested to treat CD30+ PTCL in Chinese participants. This study will look at the efficacy, safety, and pharmacokinetics (PK) of A+CHP as frontline treatment for newly diagnosed CD30+ PTCL. The study will enroll approximately 52 participants. Participants will be enrolled in a single group to receive: • Brentuximab vedotin 1.8 milligrams per kilogram (mg/kg) + Cyclophosphamide 750 milligrams per square meter (mg/m\^2), Doxorubicin 50 mg/m\^2 and Prednisone 100 mg This multi-center trial will be conducted in China. The overall time to participate in this study is approximately 36 months.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Study Director
Affiliation: Takeda
Role: STUDY_DIRECTOR
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