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

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.

NCT Number	NCT07493486
Lead Sponsor	Zhejiang Cancer Hospital
Conditions	Diffuse Large B-Cell Lymphoma (DLBCL), Intrathecal Chemotherapy
Enrollment	31 participants
Start Date	2022-02-01
Primary Completion	2023-08-31 (estimated)
Study Completion	2023-08-31 (estimated)
Updated on ClinicalTrials.gov	2026-03-25