Pianzumab Combined With AVD Regimen in the Treatment of Newly-diagnosed Advanced Classic Hodgkin Lymphoma
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Concurrent penpulimab and AVD Participants will receive Penpulimab and AVD injection at the same time for a total of 6 cycles. Cycle length = 28 days, Penpulimab and AVD will be administered on D1 and D15 of each cycle. |
Drug: Concurrent penpulimab and AVD
Participants will receive Penpulimab and AVD injection at the same time for a total of 6 cycles. Cycle length = 28 days, Penpulimab and AVD will be administered on D1 and D15 of each cycle.
|
| Experimental: Sequential penpulimab and AVD Participants will receive penpulimab for 3 cycles; follewed by 6 cycles of AVD; finally, penpulimab for 3 cycles. Cycle length = 28 days, Penpulimab and AVD will be administered on D1 and D15 of each cycle. |
Drug: Sequential penpulimab and AVD
Participants will receive penpulimab for 3 cycles; follewed by 6 cycles of AVD; finally, penpulimab for 3 cycles. Cycle length = 28 days, Penpulimab and AVD will be administered on D1 and D15 of each cycle.
|
Outcome Measures
Primary Outcome Measures
- Complete response rate （CRR） [From first injection to 24 weeks (Arm 1) From first injection to 48 weeks (Arm 2)]
Percentage of participants achieving complete response evaluated by the Independent Review Committee (IRC) at the end of all treatment courses
Secondary Outcome Measures
- Complete response rate （CRR） [From first injection to 24 weeks (Arm 1) From first injection to 48 weeks (Arm 2)]
Percentage of participants achieving complete response evaluated by researchers
- Objective response rate（ORR） [From first injection to 24 weeks (Arm 1) From first injection to 48 weeks (Arm 2)]
Percentage of participants achieve complete response and partial response
- Progression-free Survival (PFS) [Up to 5 years]
From randomization to the first occurrence of disease progression as determined by the investigator, or death due to any cause, whichever occurs first
- Overall survival (OS) [Up to 5 years]
From randomization to the time of death from any cause.
- Safety indicators [Up to 5 years]
The incedence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age: 18-70 years old (when signing the informed consent form); ECOG score: 0 or 1 point; The expected survival period exceeds 3 months;
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classic Hodgkin lymphoma (cHL) confirmed by histopathology;
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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;
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Have not received systemic anti classic Hodgkin lymphoma treatment;
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Measurable disease ;
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Adequate main organs function
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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:
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Nodular lymphocyte dominated Hodgkin lymphoma or gray area lymphoma;
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Classic Hodgkin lymphoma involves the central nervous system;
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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；
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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.
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Inoculate or expect to receive live or attenuated live vaccines or mRNA vaccines within 4 weeks before the first administration;
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Received allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
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Known to have active pulmonary tuberculosis;
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Having a history of immunodeficiency, including HIV positive or suffering from other acquired or congenital immunodeficiency diseases;
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Subjects with a known history of interstitial pneumonia, a history of non-infectious pneumonia, or highly suspected cases of interstitial pneumonia;
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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;
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Concomitant diseases and medical history:
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Has experienced or currently suffers from other malignant tumors within 3 years.
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Multiple factors affecting oral medicine (such as inability to swallow, chronic diarrhea and Bowel obstruction);
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Patients with a history of abuse of psychotropic substances who are unable to quit or have mental disorders;
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Subjects with any severe and/or uncontrollable disease.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Sun Yat-sen University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- B2023-092