Graft Versus Host Disease
Conditions
Keywords
0 to 30 years, Refractory Acute GVHD
Brief summary
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
Detailed description
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.
Interventions
PROCEDUREECP (performed on Themos UVAR-XTS or external UVA irradiator after cell collection by apheresis)
ECP (performed on Thermos UVAR-XTS or external UVA irradiator after cell collection by apheresis)
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 30 Years
Healthy volunteers
No
Inclusion criteria
* 0 to 30 years * Acute GVHD refractory to steroids (disease progression after 2 days or absence of response after 4 days) and/or second line therapy (absence of response after 8 days) * patient consent and/or parent consent
Exclusion criteria
* less of 10 kgs BW * clinical or biological state precluding the apheresis * previous GVHD therapy with anti-lymphocyte serum (excepted in the conditioning regimen)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GVHD grading | during weeks 2 to 10 |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival Incidence of chronic GVHD | during weeks 2 to 10 |
Countries
France
Contacts
Primary ContactPatrick Lacarin
Outcome results
None listed