Actively Recruiting
CNS-Relapse Prevention in High-Risk Diffuse Large B-cell Lymphoma With Thiotepa-based Autologous Stem Cell Transplant
Led by Washington University School of Medicine · Updated on 2026-03-31
36
Participants Needed
1
Research Sites
236 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CNS-Relapse Prevention in High-Risk Diffuse Large B-cell Lymphoma With Thiotepa-based Autologous Stem Cell Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed diffuse large B-cell lymphoma, large B-cell lymphoma transformed from indolent lymphoma, or high-grade B-cell lymphoma
- High risk for CNS relapse defined by CNS-IPI ≥ 4 or involvement of kidney, adrenal, testicular, breast, ovarian, uterine, skin, bone marrow, myocardium, CNS adjacent, or secondary CNS
- Double hit lymphoma with MYC and BCL2 and/or BCL6 rearrangements
- Planning to receive full anthracycline-based induction chemotherapy and have received 2 or fewer cycles at screening
- Age between 18 and 75 years
- Ability to understand and sign informed consent or have a legal representative do so
- Currently undergoing anthracycline-based induction chemotherapy
- ECOG performance status of 0, 1, or 2
- PET/CT after cycle 2 to 4 shows no disease progression and eligibility for autologous stem cell transplant
- Signed treatment consent before conditioning with thiotepa/carmustine
- Agree to use contraception during study and for specified periods after treatment
You will not qualify if you...
- Relapsed or refractory diffuse large B-cell lymphoma or high-grade B-cell lymphoma
- Diagnosis of primary CNS lymphoma
- Prior or concurrent malignancy that may interfere with study safety or results
- Receiving other investigational agents
- History of allergic reactions to thiotepa, carmustine, or similar compounds
- Pregnant or breastfeeding
- Women of childbearing potential must have negative pregnancy test within 7 days before starting induction or enrollment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
A
Amanda F Cashen, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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