Combining Pianzumab with AVD for treating advanced Hodgkin Lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and efficacy of penpulimab when combined with the AVD regimen in patients who have been newly diagnosed with advanced classic Hodgkin lymphoma. Participants will receive either concurrent or sequential treatment with penpulimab and AVD. The study aims to determine how well this combination works compared to standard treatments. It focuses on patients with specific high-risk factors associated with advanced stages of the disease.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age: ≥18 years old (when signing the informed consent form); ECOG score: 0 or 1 point; The expected survival period exceeds 3 months;
2. classic Hodgkin lymphoma (cHL) confirmed by histopathology;
3. 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;
4. Have not received systemic anti classic Hodgkin lymphoma treatment;
5. Measurable disease ;
6. Adequate main organs function
7. 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:

1. Nodular lymphocyte dominated Hodgkin lymphoma or gray area lymphoma;
2. Classic Hodgkin lymphoma involves the central nervous system;
3. 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；
4. 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.
5. Inoculate or expect to receive live or attenuated live vaccines or mRNA vaccines within 4 weeks before the first administration;
6. Received allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
7. Known to have active pulmonary tuberculosis;
8. Having a history of immunodeficiency, including HIV positive or suffering from other acquired or congenital immunodeficiency diseases;
9. Subjects with a known history of interstitial pneumonia, a history of non-infectious pneumonia, or highly suspected cases of interstitial pneumonia;
10. Patients with evidence of bleeding constitution or medical history; Within 4 weeks before the first medication, any ≥ CTC AE level 3 bleeding events (such as digestive tract bleeding, perforation, etc.) occur;
11. Concomitant diseases and medical history:

    1. Has experienced or currently suffers from other malignant tumors within 3 years.
    2. Multiple factors affecting oral medicine (such as inability to swallow, chronic diarrhea and Bowel obstruction);
    3. Patients with a history of abuse of psychotropic substances who are unable to quit or have mental disorders;
    4. Subjects with any severe and/or uncontrollable disease.

Where it's running

• Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Qingqing Cai, MD. PhD.
• Email: caiqq@sysucc.org.cn
• Phone: 0086-20-87342823

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Bone density changes with anti-PD-1 immunotherapy

  This pilot will test if anti-PD-1 immunotherapy changes bone density in adults starting approved anti-PD-1 treatment for certain early-stage cancers.

  Recruiting Vanderbilt-Ingram Cancer Center · Nashville, Tennessee · NCT07555210

• Pembrolizumab plus chemotherapy for frail adults with classical Hodgkin lymphoma who can't get standard treatment

  This phase II trial tests whether adding pembrolizumab to gemcitabine-based chemotherapy (with possible brentuximab vedotin and dacarbazine) helps frail adults newly diagnosed with classical Hodgkin lymphoma who are ineligible for standard anthracycline-based therapy.

  Recruiting Phase 2 City of Hope Medical Center · Duarte, California · NCT07275216

• ctDNA-guided therapy for relapsed or refractory Hodgkin lymphoma using pembrolizumab with GVD

  This study tests a pembrolizumab-based regimen plus chemotherapy in adults with relapsed or refractory classic Hodgkin lymphoma to see if ctDNA can guide treatment response and consolidation choices.

  Recruiting Phase 2 University of California, San Francisco · Davis, California and 5 other locations · NCT07021989

• Personalized chemotherapy reduction for advanced Hodgkin lymphoma

  This study is testing if people with advanced Hodgkin lymphoma can safely get fewer rounds of personalized chemotherapy based on their tumor DNA levels while still effectively treating their cancer.

  Recruiting at 6 sites Phase 2 University of Washington · Irvine, California and 5 other locations · NCT06745076

• Evaluating AK129 with or without AK117 for patients with resistant Classic Hodgkin Lymphoma

  This study is testing if a new treatment called AK129, alone or with another drug AK117, can help adults with tough-to-treat classic Hodgkin lymphoma feel better after other treatments have failed.

  Recruiting Phase 1/2 Akeso · Beijing · NCT06642792

• Combination of Pembrolizumab and BEAM for treating relapsed Hodgkin Lymphoma

  This study is testing if giving Pembrolizumab before and after a stem cell transplant can help people with relapsed Hodgkin Lymphoma feel better and have better outcomes.

  Recruiting Phase 2 Masonic Cancer Center, University of Minnesota · Minneapolis, Minnesota · NCT06377540

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.