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

Primary Central Nervous System Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06115824
• Other study ID #: KY2023-677
• Status: Active, not recruiting
• Start date: August 10, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: October 2023
• Source: Huashan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: September 30, 2024
• Est. primary completion date: January 30, 2024
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Primary Central Nervous System Lymphoma

Intervention

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

Locations

Country	Name	City	State
China	Department of Hematology, Huashan Hospital, Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR)	ORR is defined as the proportion of patients with a best response of CR, CRu or PR during induction therapy	At the end of induction therapy, Cycle 6-8 (each cycle is 28 days)
Secondary	PFS	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	Up to 2 years