Combining Pianzumab with AVD for treating advanced Hodgkin Lymphoma
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)
This study is testing if a new treatment combining penpulimab with the AVD regimen can help people with newly diagnosed advanced Hodgkin lymphoma feel better compared to standard treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | prednisone, Penpulimab |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05949931 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with newly diagnosed advanced classic Hodgkin lymphoma and specific high-risk factors.
Not a fit: Patients who have previously received systemic treatment for classic Hodgkin lymphoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a more effective option for patients with advanced classic Hodgkin lymphoma.
How similar studies have performed: Other studies have explored similar combinations in Hodgkin lymphoma, showing promising results, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Guangzhou, Guangdong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.