Status and phase
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About
This study is conducted to evaluate the safety and efficiency of Penpulimab combined with AVD in patients with newly- diagnosed advanced classic Hodgkin lymphoma.
Enrollment
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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 treatment;
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:
Primary purpose
Allocation
Interventional model
Masking
108 participants in 2 patient groups
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Central trial contact
Qingqing Cai, MD. PhD.
Data sourced from clinicaltrials.gov
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