It is a single arm, multicenter, phase 2 study to explore the efficacy and safety study of OR-MTX chemotherapy（Orelabrutinib, Rituximab and Methotrexate）as first-line regimens in the treatment of newly diagnosed primary central nervous system lymphoma. Objective response rate is the primary endpoint.
Histologically confirmed Primary Central Nervous System (CNS) lymphoma Age range 18-75 years old.
Eastern Cooperative Oncology Group performance status 0 to 3.
Previously untreated. Patients treated with steroid alone are eligible.
Measurable disease was defined as at least ≥1.0cm in short-diameter by MRI.
Patient with systemic, non-CNS lymphoma metastatic to the CNS.
Patient is concurrently using other approved or investigational antineoplastic agents.
Presence of active hepatitis B virus(HBV) infection (HBsAg positive and HBV-DNA≥ 104), hepatitis C virus(HCV) infection, acquired and congenital immunodeficiency diseases include but not limited to HIV.
Patient is allergic to components of the study drug.
Single group
Orelabrutinib
DrugOrelabrutinib will be given as 150 mg/d orally 72h after MTX infusion or MTX clearance, every 21 days for 6 cycles during induction treatment. Daily Orelabrutinb will be administered as maintenance treatment for up to 1 year or until disease progression, intolerable toxicity, death, informed consent withdrawal or lost of follow up (whichever occurs first).
Rituximab
Drug375mg/m2 intravenous infusion d1, every 3 weeks for 1 cycle, 6 cycles will be prescribed for induction therapy.
Methotrexate
Drug3.5g/m2 intravenous infusion for 4 hours in d1, every 21 days for 1 cycle, 6 cycles will be prescribed.
Objective response rate(ORR)
The objective response rate is defined as the proportion of patients with a response of complete response(CR) or partial response(PR).
Progression free survival
From date of patients sign informed consent until the date of progression or death or the date of last follow-up time, whichever came first, assessed up to 2 years
Treatment-related adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
ctDNA mutation and mean ctDNA concentration in serum and cerebrospinal fluid
Types of ctDNA mutations and frequency are measured by next generation sequencing. The mean ctDNA concentration is the concentration of ctDNA expressed as mean tumor molecules /ml at specific time points.
The levels of cytokine concentration in serum and cerebrospinal fluid
The levels of cytokine will be analyzed by ELISA in all patients recruited. The cytokine profile includes IL-6, IL-10, TNF-α, IFN-γ, IL-2 and IL-4
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