Tests sintilimab with rituximab and R-CHOP in untreated mediastinal lymphoma

Trial details

Who runs it

Sun Yat-sen University

Trial code

NCT06742502

Record updated

5 June 2025

Original description

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:Read full original descriptionShow less

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

Inclusion: 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.

Exclusion: previous treatment with immune checkpoint inhibitors (PD-1, PD-L1, CTLA-4, etc.); 3 History of severe allergic or allergic reactions to humanized or murine monoclonal antibodies; Subjects requiring systemic glucocorticoid therapy or other immunosuppressive therapy for a condition within 14 days prior to starting study treatment [subjects are allowed to be treated with topical, ocular, intra-articular, intranasal, and inhaled glucocorticoids (with minimal systemic absorption); short-term (≤ 7 days) glucocorticoid prophylaxis (e.g., contrast agent allergy) or for the treatment of non-autoimmune diseases (e.g., delayed hypersensitivity due to contact allergens) is allowed]. Low dose steroid debulking therapy for large tumor burden may be excluded (prednisone 30 mg bid × 5 days or equivalent doses of other steroids are allowed); Systemic anti-tumor therapy within 28 days before starting study treatment, including chemotherapy, immunotherapy, biological therapy (tumor vaccine, cytokines, or growth factors to control cancer), etc; Major surgery within 28 days or radiation therapy within 90 days prior to starting study treatment; Anti-cancer Chinese herbal medicine or Chinese patent medicine within 7 days prior to starting study treatment; Administration of live vaccines (except attenuated influenza vaccines) within 28 days prior to starting study treatment; Any active infection requiring systemic anti-infective therapy within 14 days prior to starting study treatment; Pregnant or lactating women. 15. Have uncontrolled concomitant disease. 19. Patients with a previous history of mental illness; those who are incapacitated or have limited behavioral ability; Patients with active autoimmune diseases that require systemic treatment within the past two years; patients with autoimmune diseases that do not require systemic treatment within the past two years may be enrolled; Other malignancies within the past 5 years, except for radically treated cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, breast carcinoma in situ, and cervical carcinoma in situ; Patients with known history of human immunodeficiency virus infection and/or acquired immunodeficiency syndrome; Patients with active chronic hepatitis B or active hepatitis C. Patients who are positive for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at screening must be further tested for hepatitis B virus (HBV) DNA titer (not more than 2500 copies/mL or 1000 IU/mL) and HCV RNA (not more than the lower limit of detection of the assay); Primary central nervous system lymphoma or secondary central nervous system involvement.

ClinicalTrials.gov NCT06742502