NCT05244642

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

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)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hodgkin Disease Lymphoma

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2022-02-15
• Primary completion: 2025-12-30
• Completion: 2026-03-30
• First posted: 2022-02-17
• Last updated: 2022-02-17

Locations

6 sites across 1 country: China