Thiotepa + Stem Cell Transplant for Lymphoma
(CNS-PHLAT Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What data supports the effectiveness of the treatment Thiotepa + Stem Cell Transplant for Lymphoma?
Research shows that thiotepa-based conditioning regimens, when used in autologous stem cell transplants for lymphoma, have similar effectiveness and safety compared to traditional regimens like BEAM. This suggests that thiotepa can be a valuable alternative, especially for older patients or those with more prior treatments.12345
Is the combination of Thiotepa and Stem Cell Transplant generally safe for humans?
Research shows that using thiotepa in combination with stem cell transplants for lymphoma has a safety profile similar to other common regimens, with no significant differences in survival or complications. However, some studies noted serious side effects like respiratory issues and infections, especially at higher doses or in heavily pretreated patients.14567
What makes the Thiotepa + Stem Cell Transplant treatment unique for lymphoma?
The Thiotepa + Stem Cell Transplant treatment is unique because it uses thiotepa, a drug that can penetrate the central nervous system, making it potentially more effective for lymphomas that affect this area. This treatment is an alternative to the conventional BEAM regimen and has shown comparable efficacy and safety, with a possible advantage for older patients.12458
What is the purpose of this trial?
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.
Research Team
Amanda Cashen, MD
Principal Investigator
Washington University School of Medicine
Eligibility Criteria
This trial is for high-risk patients with Diffuse Large B-cell Lymphoma (DLBCL) who are in their first complete remission and eligible for a stem cell transplant. It's not suitable for those with prior central nervous system disease or other conditions that would exclude them from safely receiving the treatments being tested.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Induction Chemotherapy
Participants receive anthracycline-based induction chemotherapy regimen per standard of care for 6 cycles
Conditioning and Transplantation
Participants undergo conditioning with thiotepa and carmustine followed by autologous stem cell transplantation (ASCT)
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Autologous Stem Cell Transplant
- Carmustine
- Thiotepa
Autologous Stem Cell Transplant is already approved in United States, European Union, Canada for the following indications:
- Multiple Myeloma
- Non-Hodgkin Lymphoma
- Hodgkin Lymphoma
- Leukemia
- Multiple Myeloma
- Non-Hodgkin Lymphoma
- Hodgkin Lymphoma
- Leukemia
- Multiple Myeloma
- Non-Hodgkin Lymphoma
- Hodgkin Lymphoma
- Leukemia
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor