A Study Comparing Corticosteroids Alone Versus Corticosteroids and Extracorporal Photopheresis (ECP) as First-line Treatment of Standard II Acute Graft-versus-host Disease — PCE-aGVHD  

Acute-graft-versus-host Disease Clinical Trial

Official title: A Multi-center Randomized Phase II Study Comparing Corticosteroids Alone Versus Corticosteroids and Extracorporal Photopheresis (ECP) as First-line Treatment of Standard Risk Grade II Acute Graft-versus-host Disease After Allogeneic Stem Cell Transplantation

Status Not yet recruiting

Clinical Trial Summary

Acute graft versus host-disease remains a major cause of morbidity and mortality after allogeneic hematopoietic stem cell transplantation. The incidence of grade II to IV acute GVHD ranges from 30 to 50% of the patients transplanted. Steroids remain the standard first line treatment for acute GVHD.

Prolonged exposure to steroids is associated to increased risk of infections and of osteoporosis, osteonecrosis and alteration of growth in children. Thus, reducing steroid exposure in order to reduce treatment-related morbidity is another important goal in the management of standard risk aGVHD.

Extracoporeal photopheresis (ECP) is active in controlling steroid refractory or dependent acute GVHD.

Hypothesis:

In this study, the team hypothesizes that addition of ECP to first line treatment with 2 mg/kg steroids of standard risk grade II aGVHD can reduce steroid exposure by increasing the probability of 6 month FFTF including absence of systemic steroids for chronic GVHD.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Acute-graft-versus-host Disease
• Graft vs Host Disease

• NCT number: NCT03605940
• Study type: Interventional
• Source: Central Hospital, Nancy, France
• Contact: Marie-Thérèse RUBIO, PU-PH
• Phone: 0383153282
• Email: m.rubio@chru-nancy.fr
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 1, 2018
• Completion date: April 1, 2022