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The purpose of this research study is to evaluate the safety and feasibility of extracorporeal photopheresis (ECP) in the treatment of steroid-refractory acute graft-versus-host disease (GVHD) in children.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extracorporeal Photopheresis | Procedure | ECP will be performed using the UVAR® XTS™ photopheresis system (Therakos). Whole blood is drawn and separated by centrifuge to collect the buffy coat (lymphocyte solution). Methoxsalen (8-MOP) is added to the blood, and the final solution of cells is passed as a film, 1mm thick, through a disposable plastic device, exposed to a UVA light source (2J/cm2/cell) and then returned to the patient. ECP will be performed weekly on 2 consecutive days for 4 weeks. After 4 weeks the interval will be prolonged to every 2 weeks and ECP will be stopped after maximal response has been maintained for 2 weeks. The actual study finishes at d56 but ECP may be continued beyond that (off-study) at the discretion of the physician. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and feasibility of extracorporeal photopheresis (ECP) in the treatment of steroid-refractory acute graft-versus-host disease (GVHD) in children. | To end of study | |
| To estimate the response rate of ECP in steroid-refractory acute GVHD in children. | To end of study |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the immunological mechanisms of ECP in acute GVHD. | To end of study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Morris Kletzel, MD | Ann & Robert H Lurie Children's Hospital of Chicago | Study Director |
| Sonali Chaudhury, MD | Ann & Robert H Lurie Children's Hospital of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ann & Robert H Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D017893 | Photopheresis |
| ID | Term |
|---|---|
| D011701 | PUVA Therapy |
| D014467 | Ultraviolet Therapy |
| D010789 | Phototherapy |
| D013812 | Therapeutics |
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| D005112 |
| Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |