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Completed

NCT Number: NCT06115824

New-diagnosed PCNSL Treated With Methotrexate (MTX) and Orelabrutinib-based Regimen

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.

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Key information

Conditions

Primary Central Nervous System Lymphoma

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Hematology, Huashan Hospital, Fudan University

Shanghai, China

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orelabrutinib

Drug

Combination of orelabrutinib on a methotrexate-based chemotherapy regimen with a starting dose of 150 mg/d

Primary outcomes

  1. Objective response rate (ORR)

    Time frame: At the end of induction therapy, Cycle 6-8 (each cycle is 28 days)

    ORR is defined as the proportion of patients with a best response of CR, CRu or PR during induction therapy

Secondary outcomes

  1. PFS

    Time frame: Up to 2 years

    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

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 3, 2023
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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