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

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

NCT ID: NCT06115824

Condition: Primary Central Nervous System Lymphoma

Conditions: Official terms:
Lymphoma

Study type: Observational

Overall status: Active, not recruiting

Study design:

Time perspective: Retrospective

Intervention:

Intervention type: Drug
Intervention name: Orelabrutinib
Description: Combination of orelabrutinib on a methotrexate-based chemotherapy regimen with a starting dose of 150 mg/d
Arm group label: Cohort B

Summary: 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: 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.

Criteria for eligibility:

Study pop:
PCNSL is a rare and highly aggressive subtype of primary extranodal non-Hodgkin's lymphoma with a distinctive clinical presentation, and more than 95% of the pathological types are diffuse large B-cell lymphomas.The current National Comprehensive Cancer Network (NCCN) guidelines recommend first-line induction therapy with high-dose methotrexate (HD-MTX) in combination with rituximab, but long-term efficacy is still unsatisfactory, with 50% of patients relapsing at around 2 years

Sampling method: Non-Probability Sample
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Locations:

Facility:
Name: Department of Hematology, Huashan Hospital, Fudan University

Address:
City: Shanghai
Country: China

Start date: August 10, 2023

Completion date: September 30, 2024

Lead sponsor:
Agency: Huashan Hospital
Agency class: Other

Source: Huashan Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06115824