Chemotherapy + Stem Cell Transplant + Romidepsin for T-Cell Lymphoma
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you stop taking medications that cause significant QT prolongation (a heart rhythm issue) and CYP3A4 inhibitors (a type of drug that affects how your body processes certain medications).
What data supports the effectiveness of the treatment Autologous Stem Cell Transplant, High Dose Chemotherapy, and Romidepsin for T-Cell Lymphoma?
Research shows that high-dose chemotherapy followed by autologous stem cell transplantation (ASCT) is effective for aggressive lymphomas, with studies indicating improved survival rates compared to conventional chemotherapy. Specifically, ASCT has shown a complete response rate of 59% in T-cell lymphoma patients, suggesting its potential effectiveness in treating this condition.12345
Is the combination of chemotherapy, stem cell transplant, and Romidepsin safe for humans?
High-dose chemotherapy with autologous stem cell transplantation (ASCT) has been used safely in various lymphoma treatments, with no toxic deaths reported in some studies. However, there can be short-term complications, and in some cases, treatment-related deaths have occurred. Romidepsin, also known as Istodax, is not specifically mentioned in the safety data provided, so its safety in combination with ASCT is not detailed here.15678
How is the treatment of Chemotherapy + Stem Cell Transplant + Romidepsin for T-Cell Lymphoma different from other treatments?
This treatment is unique because it combines high-dose chemotherapy and autologous stem cell transplant (ASCT) with romidepsin, a drug that has shown effectiveness in treating T-cell lymphoma, especially in cases where other treatments have failed. Romidepsin works as a histone deacetylase inhibitor, which can help control cancer cell growth, and its combination with ASCT may offer a new approach for patients with relapsed or refractory T-cell lymphoma.124910
What is the purpose of this trial?
The purpose of this study is to test the benefit of a chemotherapy drug called romidepsin in patients with T Cell Non-Hodgkin Lymphoma (T NHL) who have undergone autologous transplantation.
Research Team
Steven Horowitz, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Eligibility Criteria
This trial is for patients over 16 with T Cell Non-Hodgkin Lymphoma who are eligible for a stem cell transplant. They must have collected enough stem cells, be in remission after chemotherapy, and have normal liver function tests. Excluded are those with progressive disease, previous transplants, active severe infections including HIV, inadequate organ function or performance status, pregnancy or breastfeeding without contraception use, prior romidepsin therapy, CNS involvement by cancer, certain heart conditions or arrhythmias.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
High Dose Chemotherapy and Autologous Stem Cell Transplant
Participants receive high dose chemotherapy followed by autologous stem cell transplant
Maintenance Therapy
Participants receive maintenance therapy with Romidepsin
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Autologous Stem Cell Transplant
- High Dose Chemotherapy
- Romidepsin
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?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
University of Washington
Collaborator
H. Lee Moffitt Cancer Center and Research Institute
Collaborator
Weill Medical College of Cornell University
Collaborator