Clinical trial NCT06115824: A Retrospective Study of Newly-diagnosed PCNSL Treated With a Methotrexate (MTX) and Orelabrutinib-based Regimen
Official 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Primary Central Nervous System Lymphoma
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief 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.

Eligibility 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

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: At the end of induction therapy, Cycle 6-8 (each cycle is 28 days)
Secondary outcomes:
measure: PFS
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Hematology, Huashan Hospital, Fudan University
Study officials:
affiliation: Huashan Hospital
name: Tong Chen
role: PRINCIPAL_INVESTIGATOR
affiliation: Huashan Hospital
name: Tong Chen
role: STUDY_DIRECTOR
References: