This study is conducted to evaluate the safety and efficiency of Penpulimab combined with AVD in patients with newly- diagnosed advanced classic Hodgkin lymphoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Participants 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.
Participants 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.
Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University
Guangzhou, Guangdong, China
RECRUITINGComplete response rate (CRR)
Percentage of participants achieving complete response evaluated by the Independent Review Committee (IRC) at the end of all treatment courses
Time frame: From first injection to 24 weeks (Arm 1) From first injection to 48 weeks (Arm 2)
Complete response rate (CRR)
Percentage of participants achieving complete response evaluated by researchers
Time frame: From first injection to 24 weeks (Arm 1) From first injection to 48 weeks (Arm 2)
Objective response rate(ORR)
Percentage of participants achieve complete response and partial response
Time frame: From first injection to 24 weeks (Arm 1) From first injection to 48 weeks (Arm 2)
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
Time frame: Up to 5 years
Overall survival (OS)
From randomization to the time of death from any cause.
Time frame: Up to 5 years
Safety indicators
The incedence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Time frame: Up to 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.