Purpose : to evaluate the efficacy of ECP in children with refractory acute GVHD This study addresses patients with persistent GVHD after steroid and/or monoclonal antibody therapy
One arm. Six sessions in two weeks. Classification in complete response (resolution of all signs of GVHD), partial response (improvement of at least one grade) or absence of response (Glucksberg criteria). Tapering depending on patient condition during weeks 2 to 10. Final evaluation at week 10. Steroid therapy tapering at the discretion of the investigator.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
ECP (performed on Thermos UVAR-XTS or external UVA irradiator after cell collection by apheresis)
CHU Clermont-Ferrand
Clermont-Ferrand, France
RECRUITINGGVHD grading
Time frame: during weeks 2 to 10
Overall survival Incidence of chronic GVHD
Time frame: during weeks 2 to 10
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