Clinical trial · Observational
New-diagnosed PCNSL Treated With Methotrexate (MTX) and Orelabrutinib-based Regimen
A Retrospective Case-control Study of Newly-diagnosed Primary Central Nervous System Lymphoma (PCNSL) Treated With Methotrexate (MTX)-Based Chemotherapy in Combination With Orelabrutinib
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Central Nervous System Lymphoma | Primary Central Nervous System Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Orelabrutinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cohort A
- description
- Cohort A was the cohort of patients who received methotrexate-based chemotherapy alone
- label
- Cohort B
- description
- cohort B was the cohort of patients who received methotrexate-based chemotherapy + orelabrutinib.
- interventionNames
- Drug: Orelabrutinib
Primary outcomes (1)
- measure
- Objective response rate (ORR)
- timeFrame
- At the end of induction therapy, Cycle 6-8 (each cycle is 28 days)
- description
- ORR is defined as the proportion of patients with a best response of CR, CRu or PR during induction therapy
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available