Extracorporeal Photopheresis in Children and Young Adults With Refractory Acute Graft Versus Host Disease

Phase 2

• Conditions: Graft Versus Host Disease

• Registration Number: NCT00824954
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Study Timeline

• Study First Submitted: 2008-12-18
• Study First Submitted QC: 2009-01-16
• Study First Posted: 2009-01-19
• Study Start: 2009-06
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-18
• Last Update Posted: 2011-01-19
• Primary Completion: 2012-06
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
GVHD grading	during weeks 2 to 10

Secondary Outcome Measures

Name	Time	Method
Overall survival Incidence of chronic GVHD	during weeks 2 to 10

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France