NCT02203578

Romidepsin in Treating Patients With Steroid-Refractory Graft-versus-Host Disease

A Pilot Study of Romidepsin for Therapy of Graft-versus-Host Disease

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot clinical trial studies romidepsin in treating patients with graft-versus-host disease (GVHD) that has not responded to treatment with steroids. Romidepsin may be an effective treatment for graft-versus-host disease caused by a bone marrow or stem cell transplant.

Detailed description

PRIMARY OBJECTIVES: I. To determine if romidepsin should be developed as a therapy for patients with steroid-refractory GVHD. OUTLINE: Patients receive romidepsin intravenously (IV) over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 3 and 6 months.

Conditions

• Graft Versus Host Disease

Interventions

Type	Name	Description
DRUG	romidepsin	Given IV
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-06-14
• Completion: 2016-06-14
• First posted: 2014-07-30
• Last updated: 2017-03-30
• Results posted: 2017-03-30

Locations

1 site across 1 country: United States