CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 81 enrolled
Drug / intervention
Methylprednisolone +1 moredrug
Likely dose
Methylprednisolone 2 mg/kgfrom 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/NCT00609609
NCT00609609Phase 2Completed
CompareCT.gov

A Randomized Phase II Study for the Evaluation of Extracorporeal Photopheresis (ECP) in Combination With Corticosteroids for the Initial Treatment of Acute Graft-Versus-Host Disease (GVHD)

M.D. Anderson Cancer Center·interventional·Posted Feb 7, 2008·Updated Jun 4, 2018

In Brief

A Phase 2 clinical trial evaluating Photopheresis and Methylprednisolone for Graft Versus Host Disease. Completed, enrolled 81 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to find out whether adding extracorporeal photopheresis (ECP) to standard therapy for acute GVHD with corticosteroids improves response to treatment, length of treatment, and survival.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGraft Versus Host Disease
CountriesUnited States
CollaboratorsMallinckrodt

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 7, 2008
Enrollment StartJan 1, 2008
Primary CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 8 yearsPosted 18.4 years ago

Interventions

Photopheresisprocedure

8-9 photopheresis treatments weekly for days 1-14, 6 treatments weekly from days 15-28, and after that 2 treatments weekly until day 60. After day 60, your doctor will decide whether ECP is worth continuing, and the frequency of treatments.

Methylprednisolonedrug

2 mg/kg daily with a taper to no less than 1 mg/kg/day by day 14, followed by a tapering schedule according to the suggested guidelines.