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This study is conducted to evaluate the safety and efficiency of Penpulimab combined with AVD in patients with newly- diagnosed advanced classic Hodgkin lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concurrent penpulimab and AVD | Experimental | 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. |
|
| Sequential penpulimab and AVD | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Concurrent penpulimab and AVD | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate (CRR) | Percentage of participants achieving complete response evaluated by the Independent Review Committee (IRC) at the end of all treatment courses | From first injection to 24 weeks (Arm 1) From first injection to 48 weeks (Arm 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate (CRR) | Percentage of participants achieving complete response evaluated by researchers | From first injection to 24 weeks (Arm 1) From first injection to 48 weeks (Arm 2) |
| Objective response rate(ORR) |
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Inclusion Criteria:
Exclusion Criteria:
Nodular lymphocyte dominated Hodgkin lymphoma or gray area lymphoma;
Classic Hodgkin lymphoma involves the central nervous system;
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 treatmentï¼›
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.
Inoculate or expect to receive live or attenuated live vaccines or mRNA vaccines within 4 weeks before the first administration;
Received allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
Known to have active pulmonary tuberculosis;
Having a history of immunodeficiency, including HIV positive or suffering from other acquired or congenital immunodeficiency diseases;
Subjects with a known history of interstitial pneumonia, a history of non-infectious pneumonia, or highly suspected cases of interstitial pneumonia;
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;
Concomitant diseases and medical history:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingqing Cai, MD. PhD. | Contact | 0086-20-87342823 | caiqq@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| Sequential penpulimab and AVD | Drug | 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. |
|
Percentage of participants achieve complete response and partial response
| From first injection to 24 weeks (Arm 1) From first injection to 48 weeks (Arm 2) |
| Progression-free Survival (PFS) | From randomization to the first occurrence of disease progression as determined by the investigator, or death due to any cause, whichever occurs first | Up to 5 years |
| Modified progression-free survival (mPFS) | the time to progression, death, or noncomplete response and use of subsequent anticancer therapy. | Up to 5 years |
| Overall survival (OS) | From randomization to the time of death from any cause. | Up to 5 years |
| Safety indicators | The incedence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs). | Up to 5 years |