Actively Recruiting
A Multicenter Two-Cohort Study of Methotrexate, Rituximab, Sintilimab and Pirtobrutinib for Treatment-Naive PCNSL vs. Real-World Investigator-Selected Treatment (Observational Cohort)
Led by Tongji Hospital · Updated on 2026-03-09
110
Participants Needed
3
Research Sites
183 weeks
Total Duration
On this page
Sponsors
T
Tongji Hospital
Lead Sponsor
S
Shanxi Provincial People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate a new combination therapy for patients with newly diagnosed Primary Central Nervous System Lymphoma (PCNSL). The main questions it aims to answer are: (1) Does the combination of Methotrexate, Rituximab, Sintilimab, and Pirtobrutinib improve the Complete Remission Rate (CRR)? (2) Is this regimen safe and tolerable for patients? Researchers will compare this interventional group to a real-world observational group (receiving standard investigator-selected treatments) to see if the new combination improves treatment response and survival.
CONDITIONS
Official Title
A Multicenter Two-Cohort Study of Methotrexate, Rituximab, Sintilimab and Pirtobrutinib for Treatment-Naive PCNSL vs. Real-World Investigator-Selected Treatment (Observational Cohort)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Voluntarily signed informed consent
- ECOG Performance Status between 0 and 3
- Expected survival longer than 3 months
- Histopathologically confirmed Diffuse Large B-Cell Lymphoma limited to CNS or eyes (PCNSL)
- Measurable lesion on contrast-enhanced MRI larger than 10x10 mm or positive CSF cytology for leptomeningeal disease
- No previous systemic treatment for lymphoma except corticosteroids
- Adequate bone marrow and organ function (ANC >=1.5x10^9/L, PLT >=80x10^9/L, Hb >=80 g/L; bilirubin <=1.5 times upper limit normal, AST/ALT <=2.5 times upper limit normal; creatinine <=1.5 times upper limit normal or creatinine clearance >=60 mL/min)
- Stable controlled comorbidities allowed (e.g., controlled hypertension, type 2 diabetes with HbA1c <=8%, mild coronary heart disease without recent heart attack)
- Ability to communicate and complete patient-reported outcome questionnaires
- For reproductive-aged participants: no plans for pregnancy during the study and 3 months after; use of effective contraception; males prohibited from sperm donation during treatment and 3 months after
- For Observational Cohort (Palliative Care Subgroup only): confirmed DLBCL limited to CNS or eyes and available follow-up for efficacy assessment
You will not qualify if you...
- Prior treatment with PD-1/PD-L1 inhibitors or CTLA4 monoclonal antibodies
- Uncontrolled active infection
- Significant cardiovascular diseases including congestive heart failure (NYHA class III/IV), recent myocardial infarction or unstable angina within 6 months, arrhythmias requiring treatment, reduced heart function (LVEF <50%), primary cardiomyopathy, serious QTc prolongation or heart block
- Atrial fibrillation of grade EHRA 2b or higher
- Refractory hypertension
- Active hepatitis B or C infection or syphilis (exceptions for controlled infections)
- HIV infection
- Prior organ transplantation or allogeneic stem cell transplantation
- Pregnant or breastfeeding women
- Pulmonary diseases such as pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, or radiation pneumonitis unsuited for study
- Autoimmune diseases requiring systemic treatment within 2 years
- For Observational Cohort (Palliative Care Subgroup only): incomplete clinical data or inability to perform required assessments
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
The First Affiliated Hospital of Fujian Medical University
Xiamen, Fujian, China
Actively Recruiting
2
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
3
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, China, 030012
Not Yet Recruiting
Research Team
J
Jia Wei, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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