drugset / Trial / NCT07493486
IT-TT as an Effective and Well-Tolerated Strategy for CNS Prop in High-Risk DLBCL: a Prospective Ph II Study
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Thiotepa | Other / unclassified | 10 mg | Intrathecal |
| Background | Dexamethasone | Small molecule | 5 mg | Intrathecal |