Rituximab, Methotrexate, and Tepadina Induction Followed by Etoposide and Cytarabine Consolidation in Primary Central Nervous System Lymphoma
Summary
High-dose methotrexate (HD-MTX) remains the foundation of treatment for primary central nervous system lymphoma (PCNSL), but outcomes are suboptimal. The addition of rituximab has shown mixed results, partly due to limited blood-brain barrier penetration. The MATRix regimen (rituximab, HD-MTX, cytarabine, thiotepa) has improved survival but is associated with significant toxicity. Consolidation therapy is recommended after induction, but there is no standard approach. Preliminary data suggest that etoposide and cytarabine (EA) consolidation after rituximab-HD-MTX induction may offer improved tolerability, though relapse rates remain high. This study evaluates the safety, efficacy, and tolerability of a novel RMT-EA regimen-rituximab, methotrexate, and thiotepa (RMT) induction followed by etoposide and cytarabine (EA) consolidation-in newly diagnosed, untreated PCNSL patients. The aim is to improve remission depth and prolong disease-free survival, especially in younger patients.
Timeline
- Start
- 2022-12-02
- Primary completion
- 2027-12-01
- Completion
- 2029-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cytarabine | Small molecule | 2 g | Intravenous |
| Subject | Etoposide | Small molecule | 5 mg/kg | Intravenous |
| Subject | Methotrexate | Small molecule | 3.5 g/kg | Intravenous |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Subject | Thiotepa | Other / unclassified | 30 mg/m2 | Intravenous |