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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
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECP (performed on Themos UVAR-XTS or external UVA irradiator after cell collection by apheresis) | Procedure | ECP (performed on Thermos UVAR-XTS or external UVA irradiator after cell collection by apheresis) |
| Measure | Description | Time Frame |
|---|---|---|
| GVHD grading | during weeks 2 to 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival Incidence of chronic GVHD | during weeks 2 to 10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick Lacarin | Contact | 04.73.75.11.95 | placarin@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Etienne Merlin | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Recruiting | Clermont-Ferrand | 63000 | France |
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| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D047150 | Eosinophil Cationic Protein |
| ID | Term |
|---|---|
| D004722 | Endoribonucleases |
| D012260 | Ribonucleases |
| D004950 | Esterases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D047091 | Eosinophil Granule Proteins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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