Pianzumab Combined With AVD Regimen in the Treatment of Newly-diagnosed Advanced Classic Hodgkin Lymphoma
- Conditions
- Classic Hodgkin Lymphoma
- Registration Number
- NCT05949931
- Lead Sponsor
- Sun Yat-sen University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> 1. Age: 18-70 years old (when signing the informed consent form); ECOG score: 0 or 1<br> point; The expected survival period exceeds 3 months;<br><br> 2. classic Hodgkin lymphoma (cHL) confirmed by histopathology;<br><br> 3. The subject must be advanced patient, specifically defined as Ann Arbor stage III-IV<br> or IIB with any of the following high-risk factors: ? maximum diameter of<br> mediastinal mass/maximum diameter of thoracic cavity>0.33; ? There are large masses<br> with a diameter of>10cm;<br><br> 4. Have not received systemic anti classic Hodgkin lymphoma treatment;<br><br> 5. Measurable disease ;<br><br> 6. Adequate main organs function<br><br> 7. Female subjects of childbearing age should agree to use contraceptives (such as<br> Intrauterine device, contraceptives or condoms) during the study period and within 6<br> months after the end of the study; The serum or urine Pregnancy test was negative<br> within 7 days before the study was included, and must be non-lactating subjects;<br> Male participants should agree to use contraception during the study period and<br> within 6 months after the end of the study period.<br><br>Exclusion Criteria:<br><br> 1. Nodular lymphocyte dominated Hodgkin lymphoma or gray area lymphoma;<br><br> 2. Classic Hodgkin lymphoma involves the central nervous system;<br><br> 3. Subjects who have or are suspected to have active autoimmune diseases within the<br> past 2 years, or have previously suffered from autoimmune diseases and are currently<br> at high risk of recurrence and require systemic treatment;<br><br> 4. Subjects who need to use glucocorticoid (>10mg/day prednisone Equivalent dose) or<br> other immunosuppressive drugs for systemic treatment within 14 days before the first<br> administration.<br><br> 5. Inoculate or expect to receive live or attenuated live vaccines or mRNA vaccines<br> within 4 weeks before the first administration;<br><br> 6. Received allogeneic organ transplantation or allogeneic hematopoietic stem cell<br> transplantation;<br><br> 7. Known to have active pulmonary tuberculosis;<br><br> 8. Having a history of immunodeficiency, including HIV positive or suffering from other<br> acquired or congenital immunodeficiency diseases;<br><br> 9. Subjects with a known history of interstitial pneumonia, a history of non-infectious<br> pneumonia, or highly suspected cases of interstitial pneumonia;<br><br> 10. Patients with evidence of bleeding constitution or medical history; Within 4 weeks<br> before the first medication, any = CTC AE level 3 bleeding events (such as digestive<br> tract bleeding, perforation, etc.) occur;<br><br> 11. Concomitant diseases and medical history:<br><br> 1. Has experienced or currently suffers from other malignant tumors within 3<br> years.<br><br> 2. Multiple factors affecting oral medicine (such as inability to swallow, chronic<br> diarrhea and Bowel obstruction);<br><br> 3. Patients with a history of abuse of psychotropic substances who are unable to<br> quit or have mental disorders;<br><br> 4. Subjects with any severe and/or uncontrollable disease.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete response rate (CRR)
- Secondary Outcome Measures
Name Time Method Complete response rate (CRR);Objective response rate(ORR);Progression-free Survival (PFS);Overall survival (OS);Safety indicators