NCT01908777

A Phase 2 Multicenter Study of High Dose Chemotherapy With Autologous Stem Cell Transplant Followed by Maintenance Therapy With Romidepsin for the Treatment of T Cell Non-Hodgkin Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• T Cell Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
OTHER	High Dose Chemotherapy with Autologous Stem Cell Transplant Followed by Maintenance Therapy with Romidepsin

Timeline

• Start date: 2013-07-16
• Primary completion: 2025-10-03
• Completion: 2025-10-03
• First posted: 2013-07-26
• Last updated: 2025-10-09

Locations

10 sites across 1 country: United States