A Phase III Study to Evaluate the Efficacy and Safety of Penpulimab in the Relapsed and Refractory Classical Hodgkin's Lymphoma

PHASE3RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

February 15, 2022

Primary Completion Date

December 30, 2025

Study Completion Date

March 30, 2026

Conditions
Hodgkin Disease Lymphoma
Interventions
DRUG

Penpulimab

A humanized monoclonal immunoglobulin.

DRUG

Investigator's choice of Chemotherapy

Participants will receive one of the following chemotherapies, including but not limited to DHAP (cisplatin 100mg/m2 D1, high dose cytarabine 2 mg/m2 q12h D2, dexamethasone 40mg D1-4, Q3W); ESHAP (etoposide 40 mg/m2 D1-4, cisplatin 25 mg/m2 D1-4, high dose cytarabine 2 mg/m2 D5, methylprednisolone 500mg D1-4, Q3W); DICE (dexamethasone 10mg/m2 D1-4, ifosfamide 1.0g/m2 D1-4, cisplatin 25mg/m2 D1-4, etoposide 60 mg/m2 D1-4, Q3W); ICE (ifosfamide 5 mg/m2 D2, carboplatin AUC 5 D2, etoposide 100 mg/m2 D1-3, Q3W); IGEV (ifosfamide 2 mg/m2 D1-4, gemcitabine 800 mg/m2 D1, D4, vinorelbine 20mg/m2 D1, prednisone 100 mg D1-4, Q3W); GVD (gemcitabine 1g/m2 D1, D8, vinorelbine 20 mg/m2 D1, D8, liposome doxorubicin 15 mg/m2 D1, D8, Q3W); MINE (etoposide 65mg/m2 D1-3, ifosfamide 1.33g/m2 D1-3, mitoxantrone 8mg/m2 d1, Q3W); GemOx (gemcitabine 800mg/m2 D1, D8, oxaliplatin 85mg/m2 D1, Q3W); GemOx (gemcitabine 1000mg/m2 D1, oxaliplatin 100mg/m2d1, Q2W).

Trial Locations (6)

100142

RECRUITING

Beijing Cancer Hospital, Beijing

250012

NOT_YET_RECRUITING

Qilu Hospital of Shandong University, Jinan

300060

NOT_YET_RECRUITING

Tianjin Medical University Cancer Institute and Hospital, Tianjin

410008

NOT_YET_RECRUITING

Xiangya Hospital Central South University, Changsha

450003

NOT_YET_RECRUITING

Henan Cancer Hospital, Zhengzhou

510095

NOT_YET_RECRUITING

Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Peking University Cancer Hospital & Institute

OTHER

lead

Akeso

INDUSTRY

NCT05244642 - A Phase III Study to Evaluate the Efficacy and Safety of Penpulimab in the Relapsed and Refractory Classical Hodgkin's Lymphoma | Biotech Hunter | Biotech Hunter