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Brief Title: A Study of Tislelizumab as Monotherapy in Relapsed or Refractory Classical Hodgkin Lymphoma
Official Title: A Single Arm, Multicenter, Phase 2 Study of BGB-A317 as Monotherapy in Relapsed or Refractory Classical Hodgkin Lymphoma
Study ID: NCT03209973
Brief Summary: The primary objective of this study was to evaluate the efficacy of tislelizumab assessed by Independent Review Committee (IRC) in participants with relapsed or refractory classical Hodgkin lymphoma (cHL), as measured by Overall Response Rate (ORR) per the Lugano Classification
Detailed Description: This was an open-label, single-arm, multi-center Phase 2 study. Response was to be assessed by PET(positron emission tomography) and computed tomography (CT) scan per the Lugano Classification. CT scan with contrast and Positron emission tomography (PET)/CT was used as required by protocol, until progressive disease (PD), new anti-cancer therapy, withdrawal of consent, death, lost to follow-up, or end of study (EOS), whichever occurred first. Total body magnetic resonance imaging (MRI) was allowed if CT with contrast is contraindicated. During treatment with immune checkpoint inhibitor such as with tislelizumab, pseudo-progression may occur due to immune cell infiltration and other mechanisms as manifested by apparent increase of existing tumor masses or appearance of new tumor lesions. Participants were allowed to continue study treatment if there is suspicion of pseudo-progression, provided they are asymptomatic and have radiographic progression only, until a second consecutive CT scan demonstrates PD at which time study treatment was discontinued permanently. Participants were evaluated for Adverse Events (AEs) (all Grades per National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.03 \[NCI CTCAE v. 4.03\]), serious AEs (SAEs), and any AEs requiring study drug interruption or discontinuation.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Beijing Cancer Hospital, Beijing, Beijing, China
Chinese PLA General Hospital, Beijing, Beijing, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Tongji Hospital, Tongji Medical College Huazhong University of Science and Technology, Wuhan, Hubei, China
Jiangsu Province Hospital, Nanjing, Jiangsu, China
The First Affilliated Hospital of Jilin University, Changchun, Jilin, China
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
West China Hospital of Sichuan University, Chengdu, Sichuan, China
Institute of Hematology and Blood disease hospital,Chinese Academy of Medical Science, Tianjin, Tianjin, China
Tianjin Medical Universtity Cancer Institute and Hospital, Tianjin, Tianjin, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Name: Study Director
Affiliation: BeiGene
Role: PRINCIPAL_INVESTIGATOR