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

University Hospital, Clermont-Ferrand

Status and phase: Unknown; Phase 2

Conditions: Graft Versus Host Disease

Treatments: Procedure: ECP (performed on Themos UVAR-XTS or external UVA irradiator after cell collection by apheresis)

Study type: Interventional

Funder types: Other

Identifiers

NCT00824954

CHU-0043

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: Under 30 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)