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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT06687772
Phase
PHASE2
Status
Recruiting
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Conditions

  • Diffuse Large B Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Thiotepa — DRUG
    Thiotepa will be given intravenously twice daily on Days -5 and -4 over 120 minutes at a dose of 5 mg/kg.
  • Carmustine — DRUG
    Carmustine will be given intravenously on Day -6 over 120 minutes at a dose of 400 mg/m\^2.
  • Autologous Stem Cell Transplant — PROCEDURE
    Infusion of autologous peripheral blood stem cells on Day 0.
  • Anthracycline-based induction chemotherapy — DRUG
    Standard of care, not dictated by protocol.

Study Details

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.

Key Dates

Start date
Jan 16, 2025
Status verified
Mar 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2029

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Anthracycline-based induction chemotherapy + ASCT + Thiotepa + Carmustine
    * Patients should receive induction treatment with anthracycline-based chemotherapy regimen per standard of care. Between the end of induction Cycle #2 and the end of induction Cycle #4, a PET/CT scan should be performed to assess response. If there are no signs of progressive disease and the treating physician recommends patient is eligible for ASCT, patients should be consented with the treatment consent. Treatment with thiotepa and carmustine may not take place prior to this second patient consent. Within 3 weeks after the end of the final cycle of induction, a PET-/CT scan should be performed to assessconfirm treatment response and eligibility for ASCT. * After signing the treatment consent and confirming complete response (CR) following induction therapy, patients will begin conditioning with thiotepa (days -5 and -4) and carmustine (day -6), followed by ASCT on day 0.

Primary Outcome Measure

Feasibility of treatment [ Time Frame: Through completion of treatment (estimated to be 6 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Amanda F Cashen, M.D.
[email protected]
314-454-8306
Amanda F Cashen, M.D. (PRINCIPAL_INVESTIGATOR)
Nancy L Bartlett, M.D. (SUB_INVESTIGATOR)
Hunter Cassidy Cochran, M.D. (SUB_INVESTIGATOR)
Todd Fehniger, M.D., Ph.D. (SUB_INVESTIGATOR)
Brad Kahl, M.D. (SUB_INVESTIGATOR)
Neha Mehta-Shah, M.D. (SUB_INVESTIGATOR)
David Russler-Germain, M.D., Ph.D. (SUB_INVESTIGATOR)
Dilan Patel, M.D. (SUB_INVESTIGATOR)
Feng Gao, M.D., Ph.D. (SUB_INVESTIGATOR)

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Washington University School of Medicine· St Louis, MO

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