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Brief Title: A Phase III Study to Evaluate the Efficacy and Safety of Penpulimab in the Relapsed and Refractory Classical Hodgkin's Lymphoma
Official Title: A Randomized, Open, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Penpulimab Monotherapy vs. Standard Chemotherapy Selected by Investigator in the Relapsed and Refractory Classical Hodgkin's Lymphoma (R/R cHL)
Study ID: NCT05244642
Brief Summary: This is an open-label, multicenter, randomized, phase 3 trial to evaluate the efficacy of Penpulimab vs. standard chemotherapy selected by investigator in patients with relapsed or refractory classic Hodgkin's lymphoma.
Detailed Description: This is an open-label, multicenter, randomized, phase 3 trial to evaluate the efficacy of Penpulimab in patients with relapsed or refractory classic Hodgkin's lymphoma. Participants will be randomized to receive either Penpulimab monotherapy or chemotherapy of investigators' choice. The primary hypotheses of this study are that treatment with Penpulimab prolongs Progression-free Survival (PFS) in participants with relapsed or refractory Classical Hodgkin Lymphoma compared to treatment with Chemotherapy.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, Guangdong, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Xiangya Hospital Central South University, Changsha, Hunan, China
Qilu Hospital of Shandong University, Jinan, Shandong, China
Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin, China
Beijing Cancer Hospital, Beijing, , China
Name: Yuqin Song, MD
Affiliation: Peking University Cancer Hospital & Institute
Role: PRINCIPAL_INVESTIGATOR