Preventing CNS Relapse in High-Risk Diffuse Large B-cell Lymphoma with Thiotepa-based Stem Cell Transplant

Sponsor: Washington University School of Medicine

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06687772

Provider View

This study is exploring whether a specific stem cell transplant approach can help prevent cancer from returning in the brain or spinal cord for patients with high-risk diffuse large B-cell lymphoma (DLBCL).

Patient Parameters

Program Overview

Diffuse large B-cell lymphoma (DLBCL) is a type of cancer that can sometimes spread to the brain or spinal cord, known as a CNS relapse. This happens in about 5% of patients and often occurs within the first year after initial treatment, leading to a higher risk of death. To prevent this, the study is testing a stem cell transplant method using thiotepa and carmustine, which are drugs that can reach the brain better. This approach is being tested in patients who are at high risk of CNS relapse but have not yet had cancer spread to the CNS.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with diffuse large B-cell lymphoma, transformed large B-cell lymphoma, or high-grade B-cell lymphoma.
  • Considered high risk for CNS relapse based on specific criteria, such as:
    • High CNS-IPI score (≥ 4)
    • Cancer involving the kidneys, adrenal glands, or testicles
    • Double hit lymphoma with specific genetic changes
  • Must be receiving a full course of chemotherapy aimed at curing the cancer and have not completed more than 2 cycles at the time of joining the study.
  • Eligible for a stem cell transplant as determined by the doctor.
  • Aged between 18 and 75 years.
  • In good general health with an ECOG performance status of 0 to 2.
  • Women and men must agree to use effective birth control during the study and for a period after the study ends to prevent harm to a potential pregnancy.
  • Must be able to understand and agree to the study by signing a consent form. If unable, a legal representative can sign on their behalf.

Exclusion Criteria

  • Have relapsed or treatment-resistant diffuse large B-cell lymphoma or high-grade B-cell lymphoma.
  • Have primary CNS lymphoma or cancer that has already spread to the CNS.
  • Have another cancer that could affect the study's safety or results.
  • Currently taking other experimental treatments.
  • Have allergies to thiotepa, carmustine, or similar drugs.
  • Pregnant or breastfeeding women. Women of childbearing potential must have a negative pregnancy test before joining the study.

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