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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
78
2 sessions per week during 4 weeks and 1 session per week during 8 weeks
2 mg/kg/day
Probability of being free of treatment failure (probability of survival without relapse, additional line of treatment for aGVHD and systemic therapy for chronic GVHD)
Time frame: 6 months
mean of the cumulative dose of steroids
Time frame: Month 1- Month 2 - Month 3 - Month 6 - Month 12
cumulative incidence rate of infections
Time frame: Month 6 - Month 12
cumulative incidence of thromboembolic complications
Time frame: Month 3
incidence of chronic GVHD
Time frame: Month 6 - Month 12
severity of chronic GVHD
Time frame: Month 6 - Month 12
incidence rate of non-relapse mortality
Time frame: Month 6 - Month 12
incidence of disease relapse
Time frame: Month 6 - Month 12
disease-free survival
Time frame: Month 6 - Month 12
overall survival
Time frame: Month 6 - Month 12
scores of health-related quality of life using the French validated FACT-BMT
Time frame: Month 3 - Month 6 - Month 12
Total T cells number
Time frame: Month 3 - Month 6 - Month 12
CD4 T cells number
Time frame: Month 3 - Month 6 - Month 12
CD8 T cells number
Time frame: Month 3 - Month 6 - Month 12
B cells number
Time frame: Month 3 - Month 6 - Month 12
NK cells number
Time frame: Month 3 - Month 6 - Month 12
gamma globulin number
Time frame: Month 3 - Month 6 - Month 12
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