A Phase II, Multicenter Clinical Study of Sintilimab Combined With Rituximab Followed by R-CHOP Regimen in Patients With Previously Untreated Primary Mediastinal Diffuse Large B-Cell Lymphoma
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
• Voluntary participation in clinical study and fully understand, informed consent and sign informed consent form (ICF);
• Age ≥ 18 years and ≤ 75 years at the time of signing the ICF.
• treatment-naïve, no anti-lymphoma therapy.
• Primary mediastinal DLBCL was confirmed histopathologically at the study site.
• Lugano clinical stage I-IV.
• International Prognostic Score (IPI) 0-5.
• Available tumor tissue samples obtained by previous or fresh core needle aspiration or resection.
• ECOG score of 0-2.
• Expected survival greater than 12 months.
⁃ Must have at least 1 evaluable or measurable lesion that meets the LYRIC 2016 response evaluation criteria for malignant lymphoma.
⁃ Adequate organ and bone marrow function, no severe hematopoietic dysfunction and heart, lung, liver, kidney, thyroid dysfunction and immunodeficiency.
⁃ Pulse oximetry values \> 92% at rest.
⁃ Women of childbearing potential (WOBCP) must have a negative serum pregnancy test within 7 days before the first dose; WOBCP or men and their WOBCP partners should agree to use effective contraception from signing the ICF until 6 months after the last dose of study drug.