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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
CHRU de Nancy
Vandœuvre-lès-Nancy, France
Freedom from treatment failure
To be alive, without disease relapse, without second line treatment for acute GVHD and without systemic treatment for chronic GVHD
Time frame: at 6 months from randomization
steroid cumulative dose
cumulative dose of steroids over time
Time frame: at 6 months from randomization
infections
incidence rate of infections (bacteremia, septicemia, fungal infections, parasite and virus
Time frame: at 6 months from randomization
chronic GVHD
incidence and severity of chronic GVHD
Time frame: at 12 months from randomization
non-relapse mortality
non-relapse mortality rate
Time frame: at 12 months from randomization
relapse
incidence of disease relapse
Time frame: at 12 months from randomization
overall survival
overall survival logrank
Time frame: at 12 months from randomization
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