This phase II trial studies how well chemotherapy, stem cell transplant, and romidepsin work in treating patients with T-cell non-Hodgkin lymphoma. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. The patient’s stem cells that were previously collected are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Drugs used in chemotherapy, such as romidepsin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving romidepsin following stem cell transplant may be an effective treatment for T-cell non-Hodgkin lymphoma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01908777.
PRIMARY OBJECTIVE:
I. To determine a preliminary estimate of the progression-free survival of patients with T non-Hodgkin lymphoma (NHL) who receive maintenance romidepsin at 2 years post-transplant for patients transplanted in first complete remission (CR1) or first partial remission (PR1) with standard risk histologies.
SECONDARY OBJECTIVES:
I. Determine progression-free survival (PFS) at 2 years for patients transplanted in >= complete remission (CR)/second partial remission (PR2) or for patients with high risk histologies.
II. Determine the toxicities associated with romidepsin following autologous transplantation.
III. Determine the probability of overall survival (OS) at 2 years post-transplant for all patients undergoing transplant.
IV. Characterize the effect of romidepsin on immune recovery post high dose chemotherapy with autologous stem cell transplant (HDT-ASCT).
V. OS and PFS 1 year after romidepsin completion.
OUTLINE:
BEAM CHEMOTHERAPY: Patients receive carmustine intravenously (IV) over 2 hours on day -6, etoposide IV over 1 hour every 12 hours on days -5 to -2, cytarabine IV every 12 hours on days -5 to -2, and melphalan IV on day -1.
TRANSPLANT: Patients undergo autologous stem cell transplant on day 0.
MAINTENANCE: Beginning 42-80 days after transplant, patients receive romidepsin IV once every other week for 6 months, once every 3 weeks between 6 months and 1 year, and every 4 weeks between 1 and 2 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 1 year.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorSteven Michael Horwitz