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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06115824
Other study ID # KY2023-677
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


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
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