Actively Recruiting
PD-1 Inhibitor Combined With Rituximab, Methotrexate, and Orelabrutinib (PD-1i+RMO) for Newly Diagnosed PCNSL and SCNSL.
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2026-02-13
50
Participants Needed
1
Research Sites
203 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, open-label, single-arm, prospective clinical study of PD-1 inhibitor combined with rituximab, methotrexate, and orelabrutinib (PD-1i+RMO) in the treatment of newly diagnosed primary central nervous system lymphoma (ND-PCNSL) and secondary central nervous system lymphoma (SCNSL). The primary endpoint is 1-year progression-free survival (PFS).
CONDITIONS
Official Title
PD-1 Inhibitor Combined With Rituximab, Methotrexate, and Orelabrutinib (PD-1i+RMO) for Newly Diagnosed PCNSL and SCNSL.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed primary central nervous system lymphoma confirmed by tissue testing, or independently relapsed secondary central nervous system lymphoma (diffuse large B-cell lymphoma) diagnosed by WHO criteria
- Signed informed consent and ability to follow study visits and procedures
- Cranial MRI within 28 days before enrollment showing at least one measurable lesion
- Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 4
- Adequate organ and bone marrow function including specific blood counts, liver, kidney, heart, coagulation, and thyroid function
- Life expectancy greater than 3 months
- Age 18 years or older
- Use of effective contraception during treatment and for 90 days after last dose for females of childbearing potential and males with female partners of childbearing potential
You will not qualify if you...
- Disease present outside the central nervous system
- History of a second primary cancer except certain treated or cured cancers without recurrence in the past 5 years
- History of severe allergies or known hypersensitivity to PD-1 monoclonal antibody components
- Previous treatment with PD-1, PD-L1, PD-L2, CTLA-4 antibodies, CAR-T, or similar immunotherapies
- Prior allogeneic organ or stem cell transplantation
- Planned to receive other systemic anti-cancer therapies during the study
- Use of anti-cancer vaccines or immunostimulatory therapies within 3 months before first dose
- Severe infections requiring systemic therapy
- Active or suspected autoimmune disease or history within 2 years except certain controlled conditions
- Use of immunosuppressive drugs within 4 weeks before study treatment, excluding certain local or low-dose steroids
- Positive HIV antibody, active hepatitis, or uncontrolled infections
- History of idiopathic pulmonary fibrosis or pneumonia
- Active tuberculosis
- Prior severe immune-related side effects from immunotherapy
- History of neurological or psychiatric disorders
- Use of live vaccines within 4 weeks before first dose or planned during study
- History of alcohol or drug abuse
- Pregnancy or breastfeeding
- Participation in other investigational drug trials with active treatment within 1 month
- Any other condition judged by the investigator to affect safety or study evaluation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Actively Recruiting
Research Team
L
Lei Fan
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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