This study is conducted to evaluate the safety and efficiency of Penpulimab combined with AVD in patients with newly- diagnosed advanced classic Hodgkin lymphoma.
Age: ≥18 years old (when signing the informed consent form); ECOG score: 0 or 1 point; The expected survival period exceeds 3 months;
classic Hodgkin lymphoma (cHL) confirmed by histopathology;
The subject must be advanced patient, specifically defined as Ann Arbor stage III-IV or IIB with any of the following high-risk factors: ① maximum diameter of mediastinal mass/maximum diameter of thoracic cavity>0.33; ② There are large masses with a diameter of>10cm;
Have not received systemic anti classic Hodgkin lymphoma treatment;
Nodular lymphocyte dominated Hodgkin lymphoma or gray area lymphoma;
Classic Hodgkin lymphoma involves the central nervous system;
Subjects who have or are suspected to have active autoimmune diseases within the past 2 years, or have previously suffered from autoimmune diseases and are currently at high risk of recurrence and require systemic treatment；
Subjects who need to use glucocorticoid (>10mg/day prednisone Equivalent dose) or other immunosuppressive drugs for systemic treatment within 14 days before the first administration.
Parallel
Concurrent penpulimab and AVD
DrugParticipants will receive Penpulimab and AVD injection at the same time for a total of 6 cycles. Cycle length = 28 days, Penpulimab and AVD will be administered on D1 and D15 of each cycle.
Sequential penpulimab and AVD
DrugParticipants will receive penpulimab for 3 cycles; follewed by 6 cycles of AVD; finally, penpulimab for 3 cycles. Cycle length = 28 days, Penpulimab and AVD will be administered on D1 and D15 of each cycle.
Complete response rate （CRR）
Percentage of participants achieving complete response evaluated by the Independent Review Committee (IRC) at the end of all treatment courses
Complete response rate （CRR）
Percentage of participants achieving complete response evaluated by researchers
Objective response rate（ORR）
Percentage of participants achieve complete response and partial response
Progression-free Survival (PFS)
From randomization to the first occurrence of disease progression as determined by the investigator, or death due to any cause, whichever occurs first
Modified progression-free survival (mPFS)
the time to progression, death, or noncomplete response and use of subsequent anticancer therapy.
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