CompletedPhase 2

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

China31 participantsStarted 2022-02-01

Plain-language 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.

Who can participate

Age range18 Years – 100 Years

SexALL

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Inclusion criteria

✓. Voluntary participation in the clinical study: full understanding of the study, provision of written informed consent, willingness and ability to comply with all study procedures.
✓. Age ≥ 18 years, male or female.
✓. Histopathologically confirmed high-grade B-cell lymphoma, including:
✓. No prior anti-tumor therapy including chemotherapy, radiotherapy, immunotherapy, or other anti-lymphoma treatments.
✓. Intermediate or high risk of central nervous system (CNS) involvement (meeting any one of the following):
✓. Primary breast lymphoma or primary testicular lymphoma;
✓. Involvement of any of the following sites: testis, breast, kidney, adrenal gland, paranasal sinus, epidural space, uterus;
✓. CNS-IPI score ≥ 4;

Exclusion criteria

✕. History of other malignancy within the past 5 years.
✕. Burkitt lymphoma, primary central nervous system lymphoma, or B-cell lymphoma transformed from indolent lymphoma.
✕. Existing brain parenchymal or meningeal lymphoma involvement.
✕. Patients who have received any form of CNS prophylaxis.
✕

What they're measuring

2-year cumulative incidence of SCNS relapse

Timeframe: At 2 years after baseline (total study duration: 2 years)

Trial details

NCT IDNCT07493486

SponsorZhejiang Cancer Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-31

View on ClinicalTrials.gov More Diffuse Large B-Cell Lymphoma (DLBCL) trials