steroids versus ecp and steroids as first-line treatment of grade ii acute gvhd

Conditions: Graft Vs Host Disease

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.

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.

Eligibility criteria:
inclusion criteria: * age \> 18 years, * allogeneic hematopoietic stem cell transplantation received (from any type of graft and donor) after malignant or non malignant disease * patient suffering from grade ii acute gvhd with skin +/- high gi involvement (stage 2-3 skin + upper gastrointestinal tract or skin stage 3) in the 3 months following stem cell transplantation * patient requiring first line treatment for acute gvhd * patient able to start pce therapy in the 3 days after randomization * validation of the presence of a peripheral or central venous access (its type should be conform to the recommendations described in the therakos cellex operator manual), allowing to perform pce sessions weekly during 3 months. in the absence of appropriate preexisting central line at inclusion, peripheral access will be preferred. * leukocytes \> 1.5 g/l, platelets \> 30 g/l, hematocrit \> 27% (blood transfusion are permitted), based on the last available blood testing results, * patient with french health insurance, * patient informed about the clinical trial content and organization, * informed consent form signed. exclusion criteria: * - grade 1 acute gvhd, * acute gvh grade \> ii or acute gvh with lower gastrointestinal tract or with liver involvement, * relapse of the hematologic disease at time of acute gvhd, * uncontrolled ongoing infection at time of inclusion: bacterial or fungal infections, cmv reactivation with increasing cmv viral load, * hiv positivity or replicative hbv or hcv infection (based on pre-transplant assessment), * patient with allergy or contraindications to uvadex, extracorporeal photopheresis, steroids, or posaconazole (see details in the study protocol), * woman of childbearing age without efficient contraceptive method, pregnancy or breast feeding woman, * patient with history of profound venous thrombosis in the last 5 years, * patient included in another acute gvhd prospective clinical trial.