A Retrospective Study of Newly-diagnosed PCNSL Treated With a Methotrexate (MTX) and Orelabrutinib-based Regimen
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
Combination of orelabrutinib on a methotrexate-based chemotherapy regimen with a starting dose of 150 mg/d
|
Outcome Measures
Primary Outcome Measures
- Objective response rate (ORR) [At the end of induction therapy, Cycle 6-8 (each cycle is 28 days)]
ORR is defined as the proportion of patients with a best response of CR, CRu or PR during induction therapy
Secondary Outcome Measures
- PFS [Up to 2 years]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Pathologically confirmed primary central nervous system lymphoma
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Methotrexate-based chemotherapy ± orelabrutinib regimen as first-line treatment for patients
Exclusion Criteria:
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Patients receiving ≤2 cycles of treatment without efficacy evaluation
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Hematology, Huashan Hospital, Fudan University | Shanghai | China |
Sponsors and Collaborators
- Huashan Hospital
Investigators
- Principal Investigator: Tong Chen, Huashan Hospital
- Study Director: Tong Chen, Huashan Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KY2023-677