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

NCT06115824 | Completed

• 1 other identifier: KY2023-677
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Central Nervous System Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• PFS

  Up to 2 years

Study Arms (2)

Cohort A

Cohort A was the cohort of patients who received methotrexate-based chemotherapy alone

Cohort B

cohort B was the cohort of patients who received methotrexate-based chemotherapy + orelabrutinib.

Drug: Orelabrutinib

Interventions

Orelabrutinib DRUG

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

Cohort B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Pathologically confirmed primary central nervous system lymphoma
• Methotrexate-based chemotherapy ± orelabrutinib regimen as first-line treatment for patients

You may not qualify if:

• 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

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Department of Hematology, Huashan Hospital, Fudan University

Shanghai, China

Location

MeSH Terms

Interventions

orelabrutinib

Study Officials

• Tong Chen

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

• Tong Chen

  Huashan Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 3, 2023
• Study Start: August 10, 2023
• Primary Completion: January 30, 2024
• Study Completion: July 30, 2024
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)