Actively Recruiting
A Randomized, Open, Multicenter Phase II Trial of Penpulimab Combined With AVD in Newly Diagnosed Advanced Classic Hodgkin Lymphoma
Led by Sun Yat-sen University · Updated on 2026-05-01
108
Participants Needed
1
Research Sites
61 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Penpulimab combined with AVD chemotherapy in patients newly diagnosed with advanced classic Hodgkin lymphoma. This is a randomized, open-label, multicenter phase II clinical trial focused on improving treatment outcomes for this condition. The study is sponsored by Sun Yat-sen University and aims to measure how well patients respond to these treatments over time. Participants are assigned to one of two treatment groups. One group receives Penpulimab and AVD injections together for six 28-day cycles, with doses on days 1 and 15 of each cycle. The other group receives Penpulimab alone for three cycles, followed by six cycles of AVD, and then Penpulimab again for three cycles, each cycle lasting 28 days with administration on days 1 and 15. These approaches are being compared to assess different schedules of this combination therapy. During the study, participants will undergo evaluations to measure their response to treatment, including the complete response rate from the first injection up to 24 or 48 weeks depending on the group. Researchers will also monitor progression-free survival, overall survival, and safety indicators for up to five years. The study includes regular assessments to track disease status and side effects, ensuring careful monitoring throughout the trial period.
CONDITIONS
Brief Title
Pianzumab Combined With AVD Regimen in the Treatment of Newly-diagnosed Advanced Classic Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at informed consent
- ECOG performance score of 0 or 1
- Expected survival longer than 3 months
- Confirmed diagnosis of classic Hodgkin lymphoma by histopathology
- Advanced stage disease: Ann Arbor stage III-IV or IIB with high-risk factors such as mediastinal mass ratio >0.33 or mass diameter >10 cm
- No prior systemic treatment for classic Hodgkin lymphoma
- Measurable disease present
- Adequate function of main organs
- Female participants of childbearing potential agree to use contraception during the study and for 6 months after, with negative pregnancy test before enrollment
- Male participants agree to use contraception during the study and for 6 months after
You will not qualify if you...
- Nodular lymphocyte predominant Hodgkin lymphoma or gray zone lymphoma
- Involvement of the central nervous system by classic Hodgkin lymphoma
- Active or suspected autoimmune disease within the past 2 years requiring systemic treatment
- Use of glucocorticoids (>10 mg/day prednisone equivalent) or other immunosuppressive drugs within 14 days before starting treatment
- Receipt or planned receipt of live, attenuated, or mRNA vaccines within 4 weeks before starting treatment
- Previous allogeneic organ or hematopoietic stem cell transplantation
- Active pulmonary tuberculosis
- History of immunodeficiency including HIV or other acquired/congenital immunodeficiency
- Known history or suspicion of interstitial pneumonia or non-infectious pneumonia
- History or evidence of significant bleeding disorders or recent severe bleeding events
- Other malignancies within the past 3 years
- Conditions affecting ability to take oral medications
- History of psychotropic substance abuse or uncontrolled mental disorders
- Any severe or uncontrollable disease or medical condition
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks for concurrent regimen or 48 weeks for sequential regimen
Participants receive Penpulimab and AVD injections in one of two schedules: either concurrently for 6 cycles or sequentially with 3 cycles of Penpulimab, followed by 6 cycles of AVD, then 3 more cycles of Penpulimab. Each cycle lasts 28 days with treatments on Day 1 and Day 15.
2 visits per 28-day cycle (Day 1 and Day 15) for the duration of treatment
Duration - Up to 5 years
Participants are monitored for safety, progression-free survival, and overall survival for up to 5 years after treatment completion.
Periodic visits for assessments during follow-up
Trial Site Locations
Total: 1 location
1
Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
Q
Qingqing Cai, MD. PhD.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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