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

Fudan University

Status

Completed

Conditions

Primary Central Nervous System Lymphoma

Treatments

Drug: Orelabrutinib

Study type

Observational

Funder types

Other

Identifiers

NCT06115824

KY2023-677

Details and patient eligibility

About

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.

Full description

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.

Enrollment

136 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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