Primary Central Nervous System Lymphoma (PCNSL)Phase 2NCT07410520
PD-1 Inhibitor Combined With Rituximab, Methotrexate, and Orelabrutinib (PD-1i+RMO) for Newly Diagnosed PCNSL and SCNSL.
A Phase 2 study testing PD -1/PD-L1 monoclonal antibody, Rituximab (R) and Methotrexate in people with Primary Central Nervous System Lymphoma (PCNSL) and Secondary Central Nervous System Lymphoma (SCNSL), run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Central Nervous System Lymphoma (PCNSL), Secondary Central Nervous System Lymphoma (SCNSL)
- What is being tested?
- PD -1/PD-L1 monoclonal antibody, Rituximab (R) and Methotrexate
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 7 Feb 2026to 31 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- [1] Newly diagnosed PCNSL confirmed by histopathology, or independently relapsed SCNSL (diffuse large B-cell lymphoma), diagnosed according to the 2016 WHO diagnostic criteria.
- [2] Signed written informed consent, and ability to comply with protocol-specified visits and related procedures.
- [3] Cranial MRI (non-contrast + contrast) performed within 28 days prior to study enrollment must show at least one measurable lesion in two perpendicular dimensions (according to the 2014 Lugano criteria).
- [4] ECOG performance status of 0-4. [5] Adequate organ and bone marrow function, defined as follows:
- Hematology: Absolute neutrophil count (ANC) ≥ 1.0×10⁹/L, platelet count (PLT) ≥ 50×10⁹/L, hemoglobin (HGB) ≥ 8.0 g/dL; no administration of granulocyte growth factors, platelet transfusion, or red blood cell transfusion within 7 days prior to testing.
- Liver function: Serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN.
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- Renal function: Serum creatinine (Cr) ≤ 1 × ULN or creatinine clearance (CCr) ≥ 90 mL/min.
- Cardiac function: Cardiac function class below Grade III (NYHA criteria); echocardiography shows left ventricular ejection fraction (LVEF) ≥ 50%.
- Coagulation: International normalized ratio (INR) ≤ 1.5 × ULN, activated partial thromboplastin time (APTT) ≤ ULN + 10 s, and prothrombin time (PT) ≤ ULN + 3 s.
- Thyroid function: Baseline thyroid-stimulating hormone (TSH) level within normal range, or abnormal baseline TSH with normal T3/T4 and no associated symptoms.
- [6] Life expectancy > 3 months. [7] Age ≥ 18 years. [8] Female subjects of childbearing potential or male subjects with female partners of childbearing potential must use effective contraception throughout the treatment period and for 90 days after the last dose.
Who cannot join
- Presence of disease involvement outside the central nervous system.
- History of a second primary malignancy (except for adequately treated non-melanoma skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, intramucosal carcinoma of the gastrointestinal tract, or breast carcinoma that has been cured and has shown no recurrence within the past 5 years).
- History of allergic disease, severe drug allergy, or known hypersensitivity to macromolecular protein preparations or any component of the PD-1 monoclonal antibody injection formulation.
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies, or CAR-T cell therapy (or any other antibody targeting T-cell co-stimulation or checkpoint pathways).
- Previous allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Planned to receive other systemic anti-tumor therapies during the study period.
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- Use of anti-cancer vaccines or other immunostimulatory anti-tumor therapy within 3 months before the first dose.
- Severe acute or chronic infection requiring systemic therapy.
- Active, known, or suspected autoimmune disease (refer to Appendix 5), or history of such disease within the past 2 years (patients with vitiligo, psoriasis, alopecia, or Graves' disease not requiring systemic treatment in the past 2 years, hypothyroidism requiring only thyroid hormone replacement, or type 1 diabetes requiring only insulin replacement may be enrolled).
- Use of immunosuppressive drugs within 4 weeks prior to the first study treatment, excluding intranasal, inhaled, or other local glucocorticoids or physiologic doses of systemic glucocorticoids (i.e., no more than 10 mg/day prednisone or equivalent).
- Positive human immunodeficiency virus antibody (HIV-Ab), active hepatitis, or other uncontrolled infectious diseases.
- Current or previous history of idiopathic pulmonary fibrosis or idiopathic pneumonia.
- Known active tuberculosis.
- Previous history of grade ≥3 immune-related adverse events from prior immunotherapy.
- History of definite neurological or psychiatric disorders.
- Administration of any live vaccine against infectious diseases within 4 weeks before the first dose or planned use during the study period (e.g., influenza vaccine, chickenpox vaccine, etc.).
- Clear history of alcohol or drug abuse.
- Pregnancy or lactation.
- Participation in other investigational drug studies with active treatment within 1 month before the first dose.
- Any other condition that, in the investigator's judgment, may affect the evaluation of efficacy or safety in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029
Lei Fan, +8613813976136, fanlei3014@126.com
About this study
Official title: 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)
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).
Read the detailed description
Primary central nervous system lymphoma (PCNSL) is a B-cell non-Hodgkin lymphoma confined to the brain, spinal cord, cerebrospinal fluid, and/or eyes, with no evidence of systemic involvement. Patients with PCNSL have a poor prognosis, with a median survival of only 1-2 years. High-dose methotrexate (HD-MTX, >3 g/m² body surface area) remains the cornerstone of induction therapy and is often combined with other blood-brain barrier-penetrating agents, such as cytarabine or temozolomide. Recently, the addition of Bruton's tyrosine kinase (BTK) inhibitors to induction chemotherapy has been shown to significantly improve both the overall response rate (ORR) and complete response rate (CRR) in newly diagnosed patients.
To further enhance the complete response rate in patients with newly diagnosed PCNSL (ND-PCNSL) and secondary central nervous system lymphoma (SCNSL), sustain long-term remission, and improve progression-free survival (PFS) and overall survival (OS) after consolidation and maintenance therapy, this study will conduct a multicenter, open-label, prospective, single-arm clinical trial entitled: "PD-1 Inhibitor Combined with Rituximab, Methotrexate, and Orelabrutinib (PD-1i+RMO) for Newly Diagnosed PCNSL and SCNSL." The trial aims to evaluate the efficacy and safety of this combination regimen.
The PD-1i+RMO regimen is administered in 3-week cycles. After 4 cycles, disease assessment includes cranial MRI (non-contrast + contrast) and whole-body contrast-enhanced CT or PET/CT. Patients initially diagnosed via ophthalmologic examination will also undergo ophthalmic evaluation. Those with stable disease (SD) or progressive disease (PD) will discontinue the study, whereas patients achieving partial response (PR) or complete response (CR) will receive 4 additional cycles.
After completing all 8 cycles, cranial MRI (non-contrast + contrast) and PET/CT are repeated, with ophthalmologic follow-up if indicated. Patients with PR, SD, or PD after 8 cycles will exit the study. Those achieving CR will be evaluated by the investigators for autologous stem cell transplantation (ASCT) or whole-brain radiotherapy (WBRT), followed by a 2-year maintenance phase consisting of PD-1 inhibitor administered every 2 months in combination with orelabrutinib.
- Conditions
- Primary Central Nervous System Lymphoma (PCNSL), Secondary Central Nervous System Lymphoma (SCNSL)
- Being tested
- PD -1/PD-L1 monoclonal antibody, Rituximab (R), Methotrexate, Orelabrutinib, ASCT/WBRT
- Keywords
- PD-1 Inhibitor, Rituximab, Methotrexate, Orelabrutinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD -1/PD-L1 monoclonal antibodyDrug
Induction Phase: Intravenous infusion, day2, cycle1-8(Cycles: every 3 weeks) Maintenance Phase: continued every 2 months for 2 years.
Rituximab (R)Drug
Induction Phase: 375mg/m2, Intravenous infusion, day0, cycle1-8(Cycles: every 3 weeks)
MethotrexateDrug
Induction Phase: 3.5g/m2, Intravenous infusion, day1, cycle1-8(Cycles: every 3 weeks)
OrelabrutinibDrug
Induction Phase: 150mg qd(after methotrexate levels are cleared to < 0.1 μmol/L.), cycle1-8(Cycles: every 3 weeks) Maintenance Phase: 150mg qd for 2 years.
ASCT/WBRTProcedure or surgery
Patients with PR, SD, or PD after 8 cycles will discontinue the study, while those achieving CR will be evaluated by investigators for autologous stem cell transplantation (ASCT) or whole-brain radiotherapy (WBRT).
| Study group | Role | What they receive |
|---|---|---|
| PD-1 Inhibitor Combined with Rituximab, Methotrexate, and Orelabrutinib (PD-1i+RMO) | Experimental | Not described Receives: Drug: PD -1/PD-L1 monoclonal antibody; Drug: Rituximab (R); Drug: Methotrexate; Drug: Orelabrutinib; Procedure: ASCT/WBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 year Progression free survival (PFS)
PFS is defined as the time from registration to the first occurrence of progression or relapse as assessed by the investigator, or death from any cause. PFS for patients without disease progression, relapse, or death will be censored at the time of the last tumor assessment.
Measured: From date of signing the informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year
Secondary outcomes (3)
1 year overall survival (OS)
Overall survival is defined as the period from the induction registration to death from any cause. Patients who have not died until the time of the analysis will be censored at their last contact date.
Measured: From date of signing the informed consent until the date of death from any cause, whichever came first, assessed up to 1 year
Overall response rate (ORR)
ORR is the proportion of patients who achieve either a complete or partial response.
Measured: At the end of induction therapy
Adverse Events
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start7 Feb 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Central Nervous System Lymphoma (PCNSL)Studies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410520
- Sponsor's protocol ID
- 2025-SR-646
- Status last verified
- Feb 2026
- First submitted
- 8 Feb 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07410520
- Acronym / sponsor ID
- 2025-SR-646
- Conditions
- Primary Central Nervous System Lymphoma (PCNSL), Secondary Central Nervous System Lymphoma (SCNSL)
- Keywords
- PD-1 Inhibitor, Rituximab, Methotrexate, Orelabrutinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 7 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Primary central nervous system lymphoma (PCNSL) is a B-cell non-Hodgkin lymphoma confined to the brain, spinal cord, cerebrospinal fluid, and/or eyes, with no evidence of systemic involvement. Patients with PCNSL have a poor prognosis, with a median survival of only 1-2 years. High-dose methotrexate (HD-MTX, >3 g/m² body surface area) remains the cornerstone of induction therapy and is often combined with other blood-brain barrier-penetrating agents, such as cytarabine or temozolomide. Recently, the addition of Bruton's tyrosine kinase (BTK) inhibitors to induction chemotherapy has been shown to significantly improve both the overall response rate (ORR) and complete response rate (CRR) in newly diagnosed patients.
To further enhance the complete response rate in patients with newly diagnosed PCNSL (ND-PCNSL) and secondary central nervous system lymphoma (SCNSL), sustain long-term remission, and improve progression-free survival (PFS) and overall survival (OS) after consolidation and maintenance therapy, this study will conduct a multicenter, open-label, prospective, single-arm clinical trial entitled: "PD-1 Inhibitor Combined with Rituximab, Methotrexate, and Orelabrutinib (PD-1i+RMO) for Newly Diagnosed PCNSL and SCNSL." The trial aims to evaluate the efficacy and safety of this combination regimen.
The PD-1i+RMO regimen is administered in 3-week cycles. After 4 cycles, disease assessment includes cranial MRI (non-contrast + contrast) and whole-body contrast-enhanced CT or PET/CT. Patients initially diagnosed via ophthalmologic examination will also undergo ophthalmic evaluation. Those with stable disease (SD) or progressive disease (PD) will discontinue the study, whereas patients achieving partial response (PR) or complete response (CR) will receive 4 additional cycles.
After completing all 8 cycles, cranial MRI (non-contrast + contrast) and PET/CT are repeated, with ophthalmologic follow-up if indicated. Patients with PR, SD, or PD after 8 cycles will exit the study. Those achieving CR will be evaluated by the investigators for autologous stem cell transplantation (ASCT) or whole-brain radiotherapy (WBRT), followed by a 2-year maintenance phase consisting of PD-1 inhibitor administered every 2 months in combination with orelabrutinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD-1 Inhibitor Combined with Rituximab, Methotrexate, and Orelabrutinib (PD-1i+RMO) | Experimental | Drug: PD -1/PD-L1 monoclonal antibody, Drug: Rituximab (R), Drug: Methotrexate, Drug: Orelabrutinib, Procedure: ASCT/WBRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- [1] Newly diagnosed PCNSL confirmed by histopathology, or independently relapsed SCNSL (diffuse large B-cell lymphoma), diagnosed according to the 2016 WHO diagnostic criteria.
- [2] Signed written informed consent, and ability to comply with protocol-specified visits and related procedures.
- [3] Cranial MRI (non-contrast + contrast) performed within 28 days prior to study enrollment must show at least one measurable lesion in two perpendicular dimensions (according to the 2014 Lugano criteria).
- [4] ECOG performance status of 0-4. [5] Adequate organ and bone marrow function, defined as follows:
- Hematology: Absolute neutrophil count (ANC) ≥ 1.0×10⁹/L, platelet count (PLT) ≥ 50×10⁹/L, hemoglobin (HGB) ≥ 8.0 g/dL; no administration of granulocyte growth factors, platelet transfusion, or red blood cell transfusion within 7 days prior to testing.
Key exclusion criteria (20 listed)
- Presence of disease involvement outside the central nervous system.
- History of a second primary malignancy (except for adequately treated non-melanoma skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, intramucosal carcinoma of the gastrointestinal tract, or breast carcinoma that has been cured and has shown no recurrence within the past 5 years).
- History of allergic disease, severe drug allergy, or known hypersensitivity to macromolecular protein preparations or any component of the PD-1 monoclonal antibody injection formulation.
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies, or CAR-T cell therapy (or any other antibody targeting T-cell co-stimulation or checkpoint pathways).
- Previous allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PD -1/PD-L1 monoclonal antibodyInduction Phase: Intravenous infusion, day2, cycle1-8(Cycles: every 3 weeks) Maintenance Phase: continued every 2 months for 2 years. | Drug | PD-1 Inhibitor Combined with Rituximab, Methotrexate, and Orelabrutinib (PD-1i+RMO) |
| Rituximab (R)Induction Phase: 375mg/m2, Intravenous infusion, day0, cycle1-8(Cycles: every 3 weeks) | Drug | PD-1 Inhibitor Combined with Rituximab, Methotrexate, and Orelabrutinib (PD-1i+RMO) |
| MethotrexateInduction Phase: 3.5g/m2, Intravenous infusion, day1, cycle1-8(Cycles: every 3 weeks) | Drug | PD-1 Inhibitor Combined with Rituximab, Methotrexate, and Orelabrutinib (PD-1i+RMO) |
| OrelabrutinibInduction Phase: 150mg qd(after methotrexate levels are cleared to < 0.1 μmol/L.), cycle1-8(Cycles: every 3 weeks) Maintenance Phase: 150mg qd for 2 years. | Drug | PD-1 Inhibitor Combined with Rituximab, Methotrexate, and Orelabrutinib (PD-1i+RMO) |
| ASCT/WBRTPatients with PR, SD, or PD after 8 cycles will discontinue the study, while those achieving CR will be evaluated by investigators for autologous stem cell transplantation (ASCT) or whole-brain radiotherapy (WBRT). | Procedure or surgery | PD-1 Inhibitor Combined with Rituximab, Methotrexate, and Orelabrutinib (PD-1i+RMO) |
Primary outcome
1 year Progression free survival (PFS)
Time frame: From date of signing the informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year
PFS is defined as the time from registration to the first occurrence of progression or relapse as assessed by the investigator, or death from any cause. PFS for patients without disease progression, relapse, or death will be censored at the time of the last tumor assessment.
3 secondary outcomes
1 year overall survival (OS)
Time frame: From date of signing the informed consent until the date of death from any cause, whichever came first, assessed up to 1 year
Overall response rate (ORR)
Time frame: At the end of induction therapy
Adverse Events
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PD -1/PD-L1 monoclonal antibody, Rituximab (R) and Methotrexate in people with Primary Central Nervous System Lymphoma (PCNSL) and Secondary Central Nervous System Lymphoma (SCNSL), run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lei Fan (+8613813976136, fanlei3014@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1 year Progression free survival (PFS) (time frame: From date of signing the informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.