drugset / Trial / NCT03123718
High-dose Intravenous Methotrexate Versus Intrathecal Methotrexate for Central Nervous System Prophylaxis in DLBCL
Phase 3
Unknown
205 enrolled
Chonnam National University Hospital
Consortium for Improving Survival of Lymphoma · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
The outcome of patients with central nervous system (CNS) relapse in DLBCL is poor, with median survival times of 2-5 months. This fatal prognosis necessitates CNS prevention in a subgroup of patients with a high risk of CNS relapse. Intrathecal methotrexate (ITMTX) has traditionally been used, although its efficacy for CNS prophylaxis is contradictory. High-dose intravenous methotrexate (IVMTX) has been suggested as an alternative approach. Considering the lack of evidence supporting the role of ITMTX, the investigators propose to compare the efficacy of ITMTX and IVMTX for prophylaxis of CNS relapse in a subgroup of patients with DLBCL at a high risk for CNS relapse.
Timeline
- Start
- 2017-07-01
- Primary completion
- 2021-06-30
- Completion
- 2021-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methotrexate | Small molecule | 15 mg | Intrathecal |
| Subject | Methotrexate | Small molecule | 2000 mg/m2 | Intrathecal |
| Subject | Methotrexate | Small molecule | 3000 mg/m2 | Intrathecal |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Doxorubicin | Other / unclassified | — | — |
| Background | Hydrocortisone | Other / unclassified | 50 mg | Intrathecal |
| Background | Prednisone | Other / unclassified | — | — |
| Background | Rituximab | Monoclonal antibody | — | — |
| Background | Vincristine | Small molecule | — | — |