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PD-1 Inhibitor Combined With Rituximab, Methotrexate, and Orelabrutinib (PD-1i+RMO) for Newly Diagnosed PCNSL and SCNSL.

ConditionsPrimary Central Nervous System Lymphoma (PCNSL)Secondary Central Nervous System Lymphoma (SCNSL)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

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%.

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • PD -1/PD-L1 monoclonal antibody

    Drug

    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)

  • Methotrexate

    Drug

    Induction Phase: 3.5g/m2, Intravenous infusion, day1, cycle1-8(Cycles: every 3 weeks)

  • Orelabrutinib

    Drug

    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/WBRT

    Procedure/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).

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: PD-1 Inhibitor Combined with Rituximab, Methotrexate, and Orelabrutinib (PD-1i+RMO)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

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.

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

Secondary outcomes

1

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.

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
2

Overall response rate (ORR)

ORR is the proportion of patients who achieve either a complete or partial response.

Time frame
At the end of induction therapy
3

Adverse Events

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital with Nanjing Medical University

Lead sponsor

Source ClinicalTrials.gov
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