NCT07493486

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

Intrathecal Thiotepa as an Effective and Well-tolerated Strategy for Central Nervous System (CNS) Prophylaxis in High-risk Diffuse Large B-cell Lymphoma (DLBCL): a Prospective Phase II Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diffuse Large B-Cell Lymphoma (DLBCL)
• Intrathecal Chemotherapy

Interventions

Type	Name	Description
DRUG	(RCHOP or an investigator's choice) plus IT thiotepa and dexamethasone	Patients received standard immunochemotherapy (RCHOP or an investigator's choice) plus IT thiotepa (10 mg) and dexamethasone (5 mg) via LP on day 1 of each cycle for at least four cycles. Following LP, patients remained supine for 4-6 hours. CSF analyses were repeated with each IT administration. Concomitant HD-MTX was permitted for patients enrolled in parallel protocols and was accounted for in sensitivity analyses.

Timeline

• Start date: 2022-02-01
• Primary completion: 2023-08-31
• Completion: 2023-08-31
• First posted: 2026-03-25
• Last updated: 2026-03-25

Locations

1 site across 1 country: China