Clinical trial

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

Name

KY2023-677

Description

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.

Trial arms

Trial start

2023-08-10

Estimated PCD

2024-01-30

Trial end

2024-09-30

Status

Active (not recruiting)

Treatment

Orelabrutinib

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

Arms:

Cohort B

Size

Primary endpoint

Objective response rate (ORR)

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

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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}

Updated at

2023-11-03

1 organization

1 drug

1 indication

Organization

Huashan Hospital

Drug

Orelabrutinib

Indication

Primary Central Nervous System Lymphoma