Sintilimab Plus Rituximab Followed by R-CHOP Regimen in Untreated PMBL
Trial Parameters
Brief Summary
The goal of this clinical study is to evaluate the efficacy and safety of sintilimab combined with rituximab followed by R-CHOP regimen in treatment-naïve patients with primary mediastinal diffuse large B-cell lymphoma. The main questions it aims to answer are: 1. Objective response rate of sintilimab combined with rituximab 2. Objective response rate after R-CHOP regimen
Eligibility Criteria
Inclusion Criteria: 1. Voluntary participation in clinical study and fully understand, informed consent and sign informed consent form (ICF); 2. Age ≥ 18 years and ≤ 75 years at the time of signing the ICF. 3. treatment-naïve, no anti-lymphoma therapy. 4. Primary mediastinal DLBCL was confirmed histopathologically at the study site. 5. Lugano clinical stage I-IV. 6. International Prognostic Score (IPI) 0-5. 7. Available tumor tissue samples obtained by previous or fresh core needle aspiration or resection. 8. ECOG score of 0-2. 9. Expected survival greater than 12 months. 10. Must have at least 1 evaluable or measurable lesion that meets the LYRIC 2016 response evaluation criteria for malignant lymphoma. 11. Adequate organ and bone marrow function, no severe hematopoietic dysfunction and heart, lung, liver, kidney, thyroid dysfunction and immunodeficiency. 12. Pulse oximetry values \> 92% at rest. 13. Women of childbearing potential (WOBCP) must have a negative serum pregnancy test wit