NCT06133192

Steroids Versus ECP and Steroids as First-line Treatment of Grade II Acute GVHD

A Multi-center Randomized Phase II Study Comparing Corticosteroids Alone Versus Corticosteroids and Extracorporeal Photopheresis as First-line Treatment of Grade II Acute Graft-versus-host Disease With Skin Involvement Occuring After Allogeneic Stem Cell Transplantation

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Central Hospital, Nancy, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare as a first line of grade II skin acute GVHD sconventional treatment with steroids alone to a combination of steroids and extracoporeal photopheresis (ECP) The primary end point will compare Freedom from treatment failure at 6 months from randomization as defined by meeting all the following 4 conditions: * to be alive * without relapse of the hematological disease * without having required a new line of treatment for acute GVHD * without initiating a systemic treatment for chronic GVHD.

Detailed description

A multi-center randomized phase II study comparing corticosteroids alone (standard of care) versus corticosteroids and extracorporeal photopheresis as first-line treatment of Grade II acute graft-versus-host disease with skin +/- upper gastrointestinal involvement occurring after allogeneic stem cell transplantation Corticosteroids will be started at 2 mg/kg in both arms and will be tapered once acute GVHD achieves complete remission according to strict protocol guidelines (-20% of the daily dose per week until 1 mg/kg and then 10 mg twice a day in order to stop steroids within 2 to 3 months from randomization). Extracorporeal Photopheresis (ECP) will be performed in the experimental arm : 2 sessions/week during 4 weeks then 1 session/week during 8 weeks), i.e. a total of 16 ECP sessions in 12 weeks.

Conditions

• Graft Vs Host Disease

Interventions

Type	Name	Description
DRUG	Uvadex	Uvadex use for ECP
DRUG	Steroids	steroids 2 mg/kg/d

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-09-01
• Completion: 2026-01-01
• First posted: 2023-11-15
• Last updated: 2023-11-15

Locations

1 site across 1 country: France