Orelabrutinib,Rituximab and Methotrexate in Newly Diagnosed Primary Central Nervous System Lymphoma
Orelabrutinib, Rituximab and Methotrexate (OR-MTX) in Newly Diagnosed Primary Central Nervous System Lymphoma: a Single Arm, Multicenter, Phase 2 Study
Second Affiliated Hospital, School of Medicine, Zhejiang University
28 participants
Aug 1, 2022
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Orelabrutinib 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).
375mg/m2 intravenous infusion d1, every 3 weeks for 1 cycle, 6 cycles will be prescribed for induction therapy.
3.5g/m2 intravenous infusion for 4 hours in d1, every 21 days for 1 cycle, 6 cycles will be prescribed.
Locations(1)
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NCT05600660