RecruitingPhase 3NCT05244642

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)


Sponsor

Akeso

Enrollment

60 participants

Start Date

Feb 15, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This phase III trial tests penpulimab — an anti-PD-1 immunotherapy drug — in patients with classical Hodgkin's lymphoma that has relapsed (come back) or is refractory (not responding) after prior treatments, including stem cell transplant or multiple chemotherapy regimens. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of classical Hodgkin's lymphoma - Your lymphoma has relapsed or did not respond after autologous stem cell transplant, OR you have had at least 2 prior lines of chemotherapy without transplant - You have at least one measurable lesion on imaging - Your ECOG performance status is 0 or 1 (functional with minimal symptoms) - Your blood counts, liver, and kidney function are within acceptable ranges **You may NOT be eligible if...** - You have active autoimmune disease - You have active or uncontrolled infections - You are pregnant or breastfeeding - You have had prior treatment with an anti-PD-1 or anti-PD-L1 immunotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPenpulimab

A humanized monoclonal immunoglobulin.

DRUGInvestigator'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).


Locations(6)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Beijing Cancer Hospital

Beijing, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

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

View Full Details on ClinicalTrials.gov

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NCT05244642


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