Actively Recruiting
Sintilimab Plus Rituximab Followed by R-CHOP Regimen in Untreated PMBL
Led by Sun Yat-sen University · Updated on 2025-06-05
30
Participants Needed
2
Research Sites
267 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Sintilimab Plus Rituximab Followed by R-CHOP Regimen in Untreated PMBL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Aged between 18 and 75 years at consent
- No prior anti-lymphoma treatment
- Histopathologically confirmed primary mediastinal diffuse large B-cell lymphoma
- Clinical stage I to IV according to Lugano criteria
- International Prognostic Score (IPI) between 0 and 5
- Available tumor tissue samples from prior or fresh biopsy
- ECOG performance status of 0 to 2
- Expected survival longer than 12 months
- At least one measurable lesion per LYRIC 2016 criteria
- Adequate organ and bone marrow function without severe dysfunction
- Resting pulse oximetry above 92%
- Women of childbearing potential must have negative pregnancy test within 7 days before first dose
- Agreement to use effective contraception from consent until 6 months after last study drug dose
You will not qualify if you...
- Primary central nervous system lymphoma or CNS involvement
- Previous treatment with immune checkpoint inhibitors (e.g., PD-1, PD-L1, CTLA-4)
- History of severe allergic reactions to humanized or murine monoclonal antibodies
- Active autoimmune diseases requiring systemic treatment in past 2 years
- Use of systemic glucocorticoids or immunosuppressants within 14 days before study
- Other malignancies within 5 years except certain treated skin and in situ cancers
- Systemic anti-tumor therapy within 28 days before study
- Major surgery within 28 days or radiation therapy within 90 days before study
- Use of anti-cancer Chinese herbal or patent medicines within 7 days before study
- Live vaccines (except attenuated influenza) within 28 days before study
- Known HIV infection or AIDS
- Active chronic hepatitis B or C with viral load above specified limits
- Active infection needing systemic anti-infective therapy within 14 days before study
- Pregnant or lactating women
- Uncontrolled concomitant diseases
- History of mental illness or limited behavioral ability
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350014
Active, Not Recruiting
2
Sun yat-sen university cancer cencer
Guangzhou, Guangdong, China, 51006
Actively Recruiting
Research Team
Y
Yan Gao Doctor, Professior
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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