Clinical trial · Interventional
Orelabrutinib,Rituximab and Methotrexate in Newly-diagnosed Primary Central Nervous System Lymphoma(PCNSL)
a Single Arm,Multi-center,Phase II Clinical Trial of Combined Therapy for Orelabrutinib,Rituximab and Methotrexate(RMO)in Newly-diagnosed Primary Center Nervous System Lymphoma(PCNSL)
- 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 is a prospective single arm,multi-center,phase 2 study,and this study is to evaluate the efficacy and safety of Orelabrutinib,Rituximab combined with high-dose Methotrexate(RMO) as first line regimens in the treatments of newly diagnosed primary central nervous system lymphoma(PCNSL).Objective response and complete response are the primary endpoint.
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,Rituximab and Methotrexate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Orelabrutinib,Rituximab and Methotrexate
- description
- Rituximab 375 mg/m2 d1; MTX 3.5mg/m2,d2; Orelabrutinib 150g/day; every three week/cycle.
- interventionNames
- Drug: Orelabrutinib,Rituximab and Methotrexate
Primary outcomes (1)
- measure
- primary endpoint
- timeFrame
- Enrollment is expected to last for two year, followed up for five years
- description
- Objective response rate(ORR) is the primary endpoint
Secondary outcomes (1)
- measure
- secondary endpoints
- timeFrame
- Enrollment is expected to last for two year, followed up for five years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * primary central nervous system diffuse large B-cell lymphoma histologically confirmed by brain biopsy; * Aged 18-70 years * Signature of informed consent; * At least one measurable lesion; * Neutropile≥1.5X109/L,Hemoglobin≥80g/L,Platelets≥75X109/L,Billrubin\<2XULN,ALT\<4XULN,AST4XULN * The expected survival time is at least 3 months Exclusion Criteria: * Those who have contraindications to any of the components in the Orelabrutinib,Rituximab and HD-MTX * History of other malignancies that may affect the compliance of the research protocol or the analysis of the results * Severe cardiac insufficiency * Other antitumor treatments were used * Human immunodeficiency virus(HIV)antibody is positive * Pregnant or lactating women * Researchers consider if anyone not suitable for enrollment.
References
Publications (0)
Data not yet available