CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 60 enrolled
Drug / intervention
ECP Methoxsalen +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01380535
NCT01380535Early Ph 1Completed
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A Randomized Controlled Study of Extracorporeal Photopheresis (ECP) Therapy With UVADEX for the Treatment of Patients With Moderate to Severe Chronic Graft-versus-Host Disease (cGvHD)

Mallinckrodt·interventional·Posted Jun 27, 2011·Updated Feb 19, 2020

In Brief

A Early Phase 1 clinical trial evaluating ECP Methoxsalen and Standard of Care for Chronic Graft Versus Host Disease. Completed, enrolled 60 participants across 32 sites in 8 countries.

Detailed Summary

Chronic graft-versus-host disease (cGVHD) is a long-lasting complication that can occur after transplants. The transplanted cells seem to fight with the patient's own cells. Extracorporeal photopheresis (ECP) is a fairly new procedure for cGVHD. The participant gets a port to hook up to a machine. The machine removes the white blood cells, mixes them with a light-sensitive drug, shines light on it, and puts all the blood back in. This study will find out if patients respond better if they get ECP with methoxsalen, in addition to the pills normally used to treat cGVHD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Graft Versus Host Disease
CountriesAustria, France, Germany, Hungary, Italy, Spain, United Kingdom, United States
CollaboratorsParexel

Timeline

Early Ph 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 27, 2011
Enrollment StartNov 1, 2011
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 15.0 years ago

Interventions

ECP Methoxsalendrug

Methoxsalen delivered by ECP

Standard of Caredrug

Tapered prednisone with cyclosporine or tacrolimus via oral administration, consistent with local institutional practice (corticosteroids and cyclosporine A/tacrolimus)