Trials / Unknown
UnknownNCT00824954
Extracorporeal Photopheresis in Children and Young Adults With Refractory Acute Graft Versus Host Disease
Evaluation of Extracorporeal Photochemotherapy in Children and Young Adults With Refractory Acute Graft Versus Host Disease After Allogeneic Stem Cell Transplantation
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- University Hospital, Clermont-Ferrand · Academic / Other
- Sex
- All
- Age
- 30 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | ECP (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) |
Timeline
- Start date
- 2009-06-01
- Primary completion
- 2012-06-01
- Completion
- 2012-12-01
- First posted
- 2009-01-19
- Last updated
- 2011-01-19
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT00824954. Inclusion in this directory is not an endorsement.