drugset / Trial / NCT07493486

IT-TT as an Effective and Well-Tolerated Strategy for CNS Prop in High-Risk DLBCL: a Prospective Ph II Study

NCT07493486

Phase 2 Completed 31 enrolled Zhejiang Cancer Hospital
NaSingle-groupOpen-labelPrevention

Summary

This is a prospective, single-arm clinical study to evaluate the efficacy and safety of intrathecal thiotepa for the prevention of central nervous system (CNS) involvement in patients with high-aggressive B-cell lymphoma. A total of 32 subjects will be enrolled, and the study is planned to last for 2 years. Outcomes including CNS recurrence rate, time to CNS involvement, progression-free survival (PFS), overall survival (OS), and safety parameters will be assessed during the study.

Timeline

Start
2022-02-01
Primary completion
2023-08-31
Completion
2023-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Thiotepa Other / unclassified 10 mg Intrathecal
Background Dexamethasone Small molecule 5 mg Intrathecal