This phase II trial studies the effect of thiotepa and carmustine in combination with an autologous stem cell transplant in preventing the return of cancer in the central nervous system (CNS relapse) for patients with newly-diagnosed high-risk diffuse large B-cell lymphoma (DLBCL). An autologous stem cell transplant (ASCT) is a procedure involving the removal of healthy stem cells from the body, followed by treatment to kill the residual cancer cells, and then re-infusion of the previously removed healthy stem cells. ASCT is a standard treatment for people with DLBCL whose disease has come back after treatment in their central nervous system, but it is not typically given to prevent this from occurring. Thiotepa and carmustine are in a class of medications called alkylating agents. They work by slowing or stopping the growth of cancer cells in the body. Giving thiotepa and carmustine with an ASCT may be effective in preventing CNS relapse in patients with newly-diagnosed high-risk DLBCL.
Additional locations may be listed on ClinicalTrials.gov for NCT06687772.
Locations matching your search criteria
United States
Missouri
Saint Louis
Siteman Cancer Center at Washington UniversityStatus: Active
Contact: Amanda Fishback Cashen
Phone: 314-454-8306
PRIMARY OBJECTIVE:
I. To test the feasibility of receiving thiotepa/carmustine conditioning and ASCT in first complete remission in high-risk CNS relapse DLBCL patients.
SECONDARY OBJECTIVES:
I. To evaluate the safety of thiotepa/carmustine conditioning and ASCT in first complete remission in CNS high-risk DLBCL patients.
II. To evaluate the efficacy of thiotepa/carmustine conditioning and ASCT in first complete remission in CNS high-risk DLBCL patients.
TERTIARY/EXPLORATORY OBJECTIVE:
I. To determine whether presence/clearance of circulating tumor DNA in the CSF and plasma of patients receiving thiotepa/carmustine conditioning and ASCT correlates with relapse outcomes.
OUTLINE:
INDUCTION CHEMOTHERAPY: Patients receive standard of care (SOC) anthracycline-based chemotherapy on study. Patients then undergo positron emission tomography/computed tomography (PET/CT) scan between the end of the 2nd and 4th cycles of chemotherapy and 0-3 weeks after completion of chemotherapy. Patients with a complete response (CR) on PET/CT after induction chemotherapy proceed to consolidation.
CONSOLIDATION: Patients undergo SOC leukapheresis for ASCT on study. Patients then receive carmustine intravenously (IV) on day -6 and thiotepa IV over 2 hours twice daily (BID) on days -5 and -4 in the absence of disease progression or unacceptable toxicity.
TRANSPLANT: Patients undergo SOC ASCT on day 0.
All patients also undergo blood sample collection and lumbar puncture throughout the study. In addition, patients undergo PET/CT or CT scans during follow up.
After completion of study treatment, patients are followed every 3 months for 2 years.
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorAmanda Fishback Cashen
