NCT02151539

Prospective Outcomes of Second-Line Therapy in Acute Graft-Versus-Host Study Including ECP (POSTAGE)

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 19 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research trial studies medical chart review in determining outcomes of second-line therapy in patients with acute graft-versus-host disease previously treated with extracorporeal photopheresis or other systemic therapies. Gathering information about second-line therapy in patients with acute graft-versus-host disease may help doctors learn more about the disease and find better treatment.

Detailed description

PRIMARY OBJECTIVES: I. To determine 6-month freedom from treatment failure for second-line therapy for acute graft versus host disease (aGVHD). II. To show that extracorporeal photopheresis (ECP) is associated with a superior 6 month (m) freedom from treatment failure (FFTF) as compared to other treatment modalities for second line therapy for aGVHD. III. To describe health care burden in patients receiving second line therapy for acute GVHD. IV. Quality of life measurement using Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) in patients receiving second line therapy for aGVHD. OUTLINE: Study data are collected and managed using Research Electronic Data Capture (REDCap) tools at baseline and on days 5, 28, and 56. After completion of study, patients are followed up at 6 months, and 1 and 2 years.

Conditions

• Graft Versus Host Disease

Interventions

Type	Name	Description
OTHER	medical chart review	Ancillary studies
OTHER	quality-of-life assessment	Ancillary studies

Timeline

• Start date: 2014-08-29
• Primary completion: 2018-10-11
• Completion: 2018-10-11
• First posted: 2014-05-30
• Last updated: 2019-10-17

Locations

7 sites across 4 countries: United States, Austria, Germany, United Kingdom