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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.
The primary aim is to determine a preliminary estimate of the progression-free survival of patients with T NHL who receive maintenance romidepsin at 2 years post-transplant for patients transplanted in CR1 or PR1 with standard risk histologies. Secondary aims include: * Determine PFS at 2 yrs for patients transplanted in ≥CR/PR2 or for patients with high risk histologies. * Determine the toxicities associated with romidepsin following autologous transplantation * Determine the probability of OS at 2 years post transplant for all patients undergoing transplant * Characterize the effect of romidepsin on immune recovery post HDT-ASCT * OS and PFS 1 year after Romidespin completion Patients who receive romidepsin after transplant will be evaluable for the primary endpoint, and will be counted towards the accrual total. Any patient who does not receive romidepsin after transplant, regardless of reason, will be replaced. We will also accrue a second cohort of 8 patients who are transplanted in \>CR/PR2 and for high risk histologies to be analyzed for secondary endpoints only. This cohort will not be part of the primary endpoint and will be analyzed for summary statistics only. Patients who receive romidepsin after transplant will be counted towards the accrual total for Cohort 2. Any patient who does not receive romidepsin after transplant, regardless of reason, will be replaced.
Age
16 - No limit years
Sex
ALL
Healthy Volunteers
No
Moffitt Cancer Center
Tampa, Florida, United States
Memorial Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, United States
Memorial Sloan Kettering Westchester
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Weill Cornell Medical Center
New York, New York, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, United States
Fred Hutchinson Cancer Research Center (Data Collection Only)
Seattle, Washington, United States
University of Washington (Data Collection Only)
Seattle, Washington, United States
Start Date
July 16, 2013
Primary Completion Date
October 3, 2025
Completion Date
October 3, 2025
Last Updated
October 9, 2025
47
ACTUAL participants
High Dose Chemotherapy with Autologous Stem Cell Transplant Followed by Maintenance Therapy with Romidepsin
OTHER
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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