Etude comparant l’association corticoïdes et photophérèse extracorporelle au traitement conventionnel par corticoïdes dans le traitement de première ligne de la réaction aiguë du greffon contre l’hôte de grade II

Phase 1

• Conditions: Standard II acute graft-versus-host disease following allogeneic stem cell transplantation; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2017-005162-22-FR
• Lead Sponsor: CHRU de Nancy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-28
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

-Age = 18 years ;
- Having received an allogeneic stem cell transplantation for any malignant or non-malignant hemopathy and whatever the type of donor and graft.
-with grade II acute GVHD with skin involvement (stage 1-3 skin +/- stage 1 gastro intestinal) in the 3 months following the allogeneic stem cell transplantation;
- acute GVHD in the first line treatment
-validation of the presence of peripheral or central venous access allowing to perform 2 ECP per week during 3 months;
- Leucocytes > 1.5 G/L
- Platelets > 30 G/L, Haematocrite > 27% (allowed transfusions)
-Patient affiliated to a French Sécurité Social regimen
-information consent form signed.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 62
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

Exclusion Criteria

- acute GVHD of grade I
- acute GVHD of grade > II (Gastro intestinal stage > 1 or hepatic involvement) ;
- progressive hematologic disease at inclusion
-uncontrolled ongoing infection at time of inclusion: bacterial or fungal infections, increasing CMV viral load.
-HIV positivity or replicative HBV or HCV infection ;
- Contraindications for UVADEX / photopheresis / stéroids
-Pregnancy ;
- Women of child bearing potentiel not using contaception

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified