RecruitingPhase 2NCT05600660

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


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

28 participants

Start Date

Aug 1, 2022

Study Type

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a three-drug combination — orelabrutinib, rituximab, and methotrexate — for newly diagnosed primary central nervous system (CNS) lymphoma, a rare type of lymphoma (blood cancer) that occurs in the brain or spinal cord. Researchers want to see if this combination is effective and safe. **You may be eligible if...** - You are age 18 to 75 - You have been diagnosed with primary CNS lymphoma confirmed by biopsy - You have not previously received chemotherapy or radiation for this condition (steroids alone are acceptable) - Your tumor can be measured on an MRI scan - Your overall health and organ function are adequate **You may NOT be eligible if...** - You have received prior chemotherapy or radiation for CNS lymphoma - You have serious heart, kidney, or liver problems - You have an active infection (including HIV or hepatitis B/C) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

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

DRUGOrelabrutinib

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).

DRUGRituximab

375mg/m2 intravenous infusion d1, every 3 weeks for 1 cycle, 6 cycles will be prescribed for induction therapy.

DRUGMethotrexate

3.5g/m2 intravenous infusion for 4 hours in d1, every 21 days for 1 cycle, 6 cycles will be prescribed.


Locations(1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hanzhou, Zhejiang, China

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NCT05600660


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