Status:
UNKNOWN
Extracorporeal Photopheresis in Children and Young Adults With Refractory Acute Graft Versus Host Disease
Lead Sponsor:
University Hospital, Clermont-Ferrand
Conditions:
Graft Versus Host Disease
Eligibility:
All Genders
Up to 30 years
Phase:
PHASE2
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 crite...
Eligibility Criteria
Inclusion
- 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
- less of 10 kgs BW
- clinical or biological state precluding the apheresis
- previous GVHD therapy with anti-lymphocyte serum (excepted in the conditioning regimen)
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00824954
Start Date
June 1 2009
End Date
December 1 2012
Last Update
January 19 2011
Active Locations (1)
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1
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63000