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

NCT07493486 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2026-03-25

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Zhejiang Cancer Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07493486 on ClinicalTrials.gov