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Prevention study for Diffuse Large B Cell Lymphoma
Official title CNS-Relapse Prevention in High-Risk Diffuse Large B-cell Lymphoma With Thiotepa-based Autologous Stem Cell Transplant
ClinicalTrials.gov ID: NCT06687772
What this study is testing
What is Thiotepa?
Thiotepa is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for diffuse large b cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Screening
- Newly diagnosed diffuse large B-cell lymphoma, large B-cell lymphoma transformed from underlying indolent lymphoma, or high-grade B-cell lymphoma...
- 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
You likely can't join if
- (applies at both screening and treatment)
- 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 how well it works assessment of the...
- 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...
See the full eligibility criteria
- Screening
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- (applies at both screening and treatment)
- 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 how well it works assessment of the investigational regimen as determined by the PI. Patients with prior or...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- St Louis, Missouri, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include St Louis, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.