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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
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
The progression-free survival of patients
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.
Time frame: 2 Years
Progression Free Survival for patients with high risk histologies
Determine PFS at 2 yrs for patients transplanted in ≥CR/PR2 or for patients with high risk histologies.
Time frame: 2 Years
Toxicities
Determine the toxicities associated with romidepsin following autologous transplantation. Toxicities will be graded on a scale of 0 to 5 as described by the NCI- Common Terminology for Adverse Events (CTCAE), version 4.0
Time frame: 2 years
Probability of OS at 2 years post transplant
Determine the probability of OS at 2 years post transplant for all patients undergoing transplant
Time frame: 2 year post transplant
OS 1 year after Romidespin completion
OS 1 year after Romidespin completion
Time frame: 1 year
PFS 1 year after Romidespin completion
PFS 1 year after Romidespin completion
Time frame: 1 year
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Memorial Sloan Kettering Cancer Center @ Suffolk
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Memorial Sloan Kettering Westchester
Harrison, New York, United States
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Weill Cornell Medical Center
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Memorial Sloan Kettering Nassau
Uniondale, New York, United States
Fred Hutchinson Cancer Research Center (Data Collection Only)
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University of Washington (Data Collection Only)
Seattle, Washington, United States