RecruitingPhase 2NCT05390749

Sequential Treatment With RO-MTX After Pomalidomide, Orelabrutinib, Rituximab (POR) in Newly-diagnosed PCNSL

Sequential Treatment Regimens With RO-MTX After Pomalidomide, Orelabrutinib, Rituximab (POR) as Frontline Therapy for Primary Central Nervous System Lymphoma: a Multicenter Prospective Single Arm Trial


Sponsor

Peking Union Medical College Hospital

Enrollment

50 participants

Start Date

Apr 11, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multicenter prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of sequential treatment regimens with RO-MTX after pomalidomide, orelabrutinib, rituximab (POR) in newly-diagnosed primary central nervous system lymphoma, and explore the feasibility of chemo-free treatment in PCNSL. The primary objective was the overall response rate (ORR; defined as partial response \[PR\] or better) after 4 cycles of POR.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a sequential treatment approach for people newly diagnosed with primary CNS lymphoma — a rare lymphoma that grows in the brain or spinal cord. After initial treatment with pomalidomide and orelabrutinib, patients receive a consolidation regimen using methotrexate (RO-MTX) to build on the response achieved. **You may be eligible if...** - You are between 18 and 70 years old - You have been newly diagnosed with primary CNS lymphoma confirmed as B-cell type - Your bone marrow blood production is within acceptable range - Your lymphoma is limited to the central nervous system and has not spread from another site in the body **You may NOT be eligible if...** - Your lymphoma is T-cell type (not B-cell) - Your lymphoma originated outside the brain and spread to it - You have an active serious infection - You have had a recent heart attack or unstable heart disease - 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 150mg orally d1-d21 for 6 cycles,every 21 days for 1 cycle.

DRUGPomalidomide

Pomalidomide will be given as 4mg d1-d14 for 4 cycles,every 21 days for 1 cycle.

DRUGRituximab

Rituximab 375mg/m2 intravenous infusion d1, every 21 days for 1 cycle. 6 cycles will be prescribed as protocol

DRUGMethotrexate

methotrexate 3.5g/m2 civ d1/cycle5-6


Locations(3)

Beijing TianTan Hospital

Beijing, Beijing Municipality, China

Sanbo Brain Hospital Capital Medical University

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

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NCT05390749


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