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A Phase 2, Single-Arm, Open-label Study of Brentuximab Vedotin in Chinese Patients With Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL) or Systemic Anaplastic Large Cell Lymphoma (sALCL)
The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics (PK) of brentuximab vedotin as a single agent in Chinese participants with relapsed/refractory CD30+ Hodgkin Lymphoma (HL) or Systemic Anaplastic Large Cell Lymphoma (sALCL).
The drug being tested in this study is called brentuximab vedotin. This study will look at efficacy, safety and PK of brentuximab vedotin in Chinese participants with relapsed/refractory CD30+ HL or sALCL. The study will enroll approximately 30 patients. Participants will receive: • Brentuximab vedotin 1.8 mg/kg All participants will be administered IV infusion on Day 1 each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles. This multi-center trial will be conducted in China only. The overall time to participate in this study is 3.5 years. Participants will make multiple visits to the clinic, and will be followed for overall survival (OS) every 12 weeks until death, withdrawal of consent, 18 months after end of treatment (EOT) or study closure, whichever occurs first.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Sun Yat-san University Cancer Center
Guangzhou, Guangdong, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Jiangsu Province People's Hospital
Nanjing, Jiangsu, China
The First Hospital of Jilin University
Changchun, Jilin, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Start Date
November 7, 2016
Primary Completion Date
August 2, 2018
Completion Date
February 3, 2020
Last Updated
February 24, 2021
39
ACTUAL participants
Brentuximab Vedotin
DRUG
Lead Sponsor
Takeda
NCT07209059
NCT02287311
Data Source & Attribution
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