RecruitingPhase 2

Pianzumab Combined With AVD Regimen in the Treatment of Newly-diagnosed Advanced Classic Hodgkin Lymphoma

China108 participantsStarted 2023-10-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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;
✓. 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.

Exclusion criteria

✕. 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.
✕. Inoculate or expect to receive live or attenuated live vaccines or mRNA vaccines within 4 weeks before the first administration;
✕. Received allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
✕. Known to have active pulmonary tuberculosis;
✕. Having a history of immunodeficiency, including HIV positive or suffering from other acquired or congenital immunodeficiency diseases;

What they're measuring

Complete response rate （CRR）

Timeframe: From first injection to 24 weeks (Arm 1) From first injection to 48 weeks (Arm 2)

Trial details

NCT IDNCT05949931

SponsorSun Yat-sen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-30

Contact for this trial

Qingqing Cai, MD. PhD.

0086-20-87342823 caiqq@sysucc.org.cn

View on ClinicalTrials.gov More Classic Hodgkin Lymphoma trials