A Retrospective Study of Newly-diagnosed PCNSL Treated With a Methotrexate (MTX) and Orelabrutinib-based Regimen

Study Overview
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Brief Summary
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This study was a single-centre, retrospective study that retrospectively collected first-line PCNSL patients receiving methotrexate-based chemotherapy ± orelabrutinib at Huashan Hospital of Fudan University. The study was divided into two retrospective cohorts, Cohort A was a cohort of patients receiving methotrexate-based chemotherapy alone, and Cohort B was a cohort of patients receiving methotrexate-based chemotherapy + orelabrutinib.

Detailed Description
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The study was divided into two retrospective cohorts of approximately 35-40 patients each. Cohort A was the cohort of patients who received methotrexate-based chemotherapy alone, and cohort B was the cohort of patients who received methotrexate-based chemotherapy + orelabrutinib. Statistical analyses such as propensity score analysis (PSM) and inverse probability weighted (IPTW) analysis were performed, focusing on comparing and analysing the short-term efficacy data (ORR, CR) and long-term efficacy data (PFS, OS) of the two cohorts.

Official Title
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A Retrospective Case-control Study of Newly-diagnosed Primary Central Nervous System Lymphoma (PCNSL) Treated With Methotrexate (MTX)-Based Chemotherapy in Combination With Orelabrutinib

Conditions
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Primary Central Nervous System Lymphoma

Intervention / Treatment
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* Drug: Orelabrutinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically confirmed primary central nervous system lymphoma Methotrexate-based chemotherapy ± orelabrutinib regimen as first-line treatment for patients Exclusion Criteria: Patients receiving ≤2 cycles of treatment without efficacy evaluation Those with uncontrolled or significant cardiovascular disease, including: uncontrolled diabetes mellitus, severe cardiac, pulmonary, hepatic, renal insufficiency) and haematological, endocrine system lesions, history of other uncontrollable malignancies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort A<br>Cohort A was the cohort of patients who received methotrexate-based chemotherapy alone | |
| Cohort B<br>cohort B was the cohort of patients who received methotrexate-based chemotherapy + orelabrutinib. | Drug: Orelabrutinib<br>* Combination of orelabrutinib on a methotrexate-based chemotherapy regimen with a starting dose of 150 mg/d<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | ORR is defined as the proportion of patients with a best response of CR, CRu or PR during induction therapy | At the end of induction therapy, Cycle 6-8 (each cycle is 28 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression-free survival is calculated from the date of start of therapy until the date of first documented progress or death due to any cause | Up to 2 years |