A Randomized, Open, Multicenter Phase II Clinical Trial of Pianzumab Combined With AVD Regimen in the Treatment of Newly-diagnosed Advanced Classic Hodgkin Lymphoma (PENAHL Study)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study is conducted to evaluate the safety and efficiency of Penpulimab combined with AVD in patients with newly- diagnosed advanced classic Hodgkin lymphoma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age: 18-70 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;

• Measurable disease ;

• Adequate main organs function

• Female subjects of childbearing age should agree to use contraceptives (such as Intrauterine device, contraceptives or condoms) during the study period and within 6 months after the end of the study; The serum or urine Pregnancy test was negative within 7 days before the study was included, and must be non-lactating subjects; Male participants should agree to use contraception during the study period and within 6 months after the end of the study period.

Locations
Other Locations
China
Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University
RECRUITING
Guangzhou
Contact Information
Primary
Qingqing Cai, MD. PhD.
caiqq@sysucc.org.cn
0086-20-87342823
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2027-12
Participants
Target number of participants: 108
Treatments
Experimental: Concurrent penpulimab and AVD
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.
Experimental: Sequential penpulimab and AVD
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.
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov