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Thiotepa-based Transplant for High-Risk DLBCL

This study is looking at a treatment approach for people with high-risk diffuse large B-cell lymphoma (DLBCL), a type of blood cancer. About 5% of people with DLBCL can have the cancer spread to their brain or spinal cord (central nervous system or CNS), which is very serious. This study aims to see if a specific treatment can help prevent this from happening. You would receive standard chemotherapy, followed by high-dose chemotherapy with Carmustine and Thiotepa, and then an autologous stem cell transplant (using your own stem cells). Researchers want to see if this treatment is practical and safe. You may be eligible if you are 18 to 75 years old and have newly diagnosed DLBCL or high-grade B-cell lymphoma. The study is currently unclear on its recruitment status and plans to enroll 36 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 36 participants, but the phase and specific design (like randomized or single-arm) are not specified.
What's involved
You would receive standard induction chemotherapy, followed by Carmustine and Thiotepa, and then an autologous stem cell transplant. The feasibility of this treatment will be measured for approximately 6 months.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, feasibility of treatment, will be measured through the completion of treatment, estimated to be 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06687772

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

Recruiting
PHASE2Ages 18–75InterventionalTreatment
Washington University School of Medicine
~36 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:ThiotepaCarmustineAutologous Stem Cell TransplantAnthracycline-based induction chemotherapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of treatment
Measured over Through completion of treatment (estimated to be 6 months)

Conditions

Diffuse Large B Cell Lymphoma

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Diffuse Large B-Cell LymphomaHigh Grade B-Cell LymphomaBCL2 GeneBCL6 GeneMYC Gene

Where it's being run

1 sites across 1 states
Missouri1

Study leadership

  • Amanda F Cashen, M.D. · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

Who to contact

Amanda F Cashen, M.D.
[email protected]
314-454-8306
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Newly diagnosed diffuse large B-cell lymphoma, large B-cell lymphoma transformed from underlying indolent lymphoma, or high-grade B-cell lymphoma. Patients with secondary CNS lymphoma are eligible. Patients with Richter's transformation are NOT eligible.
At high risk for CNS relapse prior to start of induction as defined by at least one of the criteria below:
CNS-IPI ≥ 4
Kidney or adrenal involvement
Testicular involvement
Breast involvement
Ovarian involvement
Uterine involvement
Skin involvement
Double hit lymphoma as defined by containing translocations of MYC gene together with rearrangement of BCL2 and/or BCL6.
Bone marrow involvement
Myocardium involvement
CNS adjacent
Secondary CNS involvement
Intend to receive a full course of curative-intent anthracycline-based induction treatment and has not yet received more than 2 cycles at the time of screening. Can receive induction chemotherapy outside of Siteman if still compliant with study eligibility, laboratory studies, lumbar punctures, imaging, and other events.
Ages 18 to 75.
Ability to understand and willingness to sign an IRB-approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants if patient is otherwise unable to sign for themselves or unable to understand consent document.
Currently undergoing anthracycline-based induction treatment. Dose modifications and/or delays during induction therapy may be made at the discretion of the treating physician and will not affect eligibility for continuation in the study.
ECOG performance status ≤ 2.
PET/CT assessment performed between the end of induction Cycle #2 and end of induction Cycle #4 demonstrates no evidence of progressive disease, and patient is eligible for autologous stem cell transplant as determined by the treating physician.
Has signed treatment consent form following mid-induction PET/CT and prior to conditioning treatment with thiotepa/carmustine.
Thiotepa and carmustine can cause fetal harm when administered to a pregnant person. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study treatment, and for 6 months following receipt of thiotepa and/or carmustine (for women) and 12 months following receipt of thiotepa and/or carmustine (or 3 months following receipt of carmustine if discontinuing before thiotepa) (for men). Should a woman become pregnant or suspect she is pregnant during treatment or within 6 months of the last dose of either thiotepa or carmustine or should a man suspect he has fathered a child, s/he must inform the treating physician immediately.

Exclusion

Relapsed or refractory diffuse large B-cell lymphoma or high-grade B-cell lymphoma. Prior treatment for underlying indolent lymphoma is permitted.
Diagnosis of primary CNS lymphoma.
Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen as determined by the PI. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial.
Currently receiving any other investigational agents.
A history of allergic reactions attributed to compounds of similar chemical or biologic composition to thiotepa, carmustine, or other agents used in the study.
Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 7 days prior to start of induction (for people enrolling prior to induction) or within 7 days of enrollment (for people enrolling after the start of induction).

What this trial measures

  • Feasibility of treatmentThrough completion of treatment (estimated to be 6 months)

    \- The treatment (thiotepa/carmustine conditioning and ASCT) will be considered feasible if \> 50% of enrolled patients meet the following criteria: * Achieve CR at the end of induction chemotherapy * Remain eligible for ASCT * Collect sufficient stem cells for ASCT (CD34+ cell goal ≥2 x 10\^6/kg) * Complete thiotepa/carmustine chemotherapy and undergo ASCT