RecruitingPhase 2NCT06687772

CNS-Relapse Prevention in High-Risk Diffuse Large B-cell Lymphoma With Thiotepa-based Autologous Stem Cell Transplant

Safety and Feasibility Study for CNS-Relapse Prevention in High-Risk Diffuse Large B-cell Lymphoma With Thiotepa-based Autologous Stem Cell Transplant (CNS-PHLAT)


Sponsor

Washington University School of Medicine

Enrollment

36 participants

Start Date

Jan 16, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

A serious consequence of systemic diffuse large B-cell lymphoma (DLBCL) is secondary central nervous system (CNS) relapse, which occurs in approximately 5% of all patients. Many CNS relapses occur within the first year after completion of frontline treatment and are associated with significantly increased mortality; thus, it is important to tailor frontline treatment to provide prophylaxis against CNS relapse in those patients who are determined to be high-risk. Autologous stem cell transplantation (ASCT) is standard of care for patients with DLBCL who relapse one year or more after first remission, and it has been shown to improve progression-free survival for patients with primary CNS lymphoma. The four-drug BEAM regimen (carmustine, etoposide, cytarabine, and melphalan) is the preferred conditioning regimen for DLBCL patients undergoing ASCT; however, patients with primary CNS lymphoma receive thiotepa plus carmustine as their conditioning regimen due to its better CNS penetration. This study tests the hypothesis that consolidation thiotepa/carmustine ASCT in first complete remission will reduce the risk of CNS relapse in transplant-eligible patients with DLBCL with no prior CNS disease at high risk of secondary CNS recurrence.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a high-dose chemotherapy regimen containing thiotepa — delivered as part of a stem cell transplant — can prevent the cancer from spreading to the brain and spinal cord in people with newly diagnosed high-risk Diffuse Large B-cell Lymphoma (DLBCL). **You may be eligible if...** - You have been newly diagnosed with Diffuse Large B-cell Lymphoma (DLBCL) or related aggressive B-cell lymphoma - You have at least one risk factor for cancer spreading to the brain (such as a high CNS-IPI score, or involvement of the kidneys, testes, breast, or other high-risk sites) - You are 18–75 years old - You plan to receive standard first-line treatment (chemotherapy) - You are a candidate for a stem cell transplant **You may NOT be eligible if...** - Your lymphoma has already relapsed or not responded to treatment - You have primary CNS lymphoma (cancer that started in the brain) - You are pregnant or breastfeeding - You have a known allergy to thiotepa, carmustine, or related drugs - You are currently in another interventional clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGThiotepa

Thiotepa will be given intravenously twice daily on Days -5 and -4 over 120 minutes at a dose of 5 mg/kg.

DRUGCarmustine

Carmustine will be given intravenously on Day -6 over 120 minutes at a dose of 400 mg/m\^2.

PROCEDUREAutologous Stem Cell Transplant

Infusion of autologous peripheral blood stem cells on Day 0.

DRUGAnthracycline-based induction chemotherapy

Standard of care, not dictated by protocol.


Locations(1)

Washington University School of Medicine

St Louis, Missouri, United States

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NCT06687772


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