drugset / Trial / NCT03123718

High-dose Intravenous Methotrexate Versus Intrathecal Methotrexate for Central Nervous System Prophylaxis in DLBCL

NCT03123718

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

EvaluationDrugModalityDoseRoute
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