Extracorporeal Photopheresis for Acute Graft Versus Host Disease
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|ClinicalTrials.gov Identifier: NCT00179855|
Recruitment Status : Unknown
Verified October 2010 by Ann & Robert H Lurie Children's Hospital of Chicago.
Recruitment status was: Recruiting
First Posted : September 16, 2005
Last Update Posted : October 11, 2010
|Condition or disease||Intervention/treatment||Phase|
|Graft Versus Host Disease Cancer Stem Cell Transplantation||Procedure: Extracorporeal Photopheresis||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Extracorporeal Photopheresis for Steroid-refractory Acute GVHD in Children and Young Adults: a Safety and Feasibility Study.|
|Study Start Date :||July 2003|
|Estimated Primary Completion Date :||July 2012|
|Estimated Study Completion Date :||July 2012|
- Procedure: Extracorporeal Photopheresis
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.
- To evaluate the safety and feasibility of extracorporeal photopheresis (ECP) in the treatment of steroid-refractory acute graft-versus-host disease (GVHD) in children. [ Time Frame: To end of study ]
- To estimate the response rate of ECP in steroid-refractory acute GVHD in children. [ Time Frame: To end of study ]
- To evaluate the immunological mechanisms of ECP in acute GVHD. [ Time Frame: To end of study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00179855
|Contact: Morris Kletzel, MDfirstname.lastname@example.org|
|Contact: Meredith Marshall||773-880-8153||MeMarchall@childrensmemorial.org|
|United States, Illinois|
|Children's Memorial Hospital||Recruiting|
|Chicago, Illinois, United States, 60614|
|Contact: Morris Kletzel, MD 773-880-4562 MKletzel@childrensmemorial.org|
|Principal Investigator:||Morris Kletzel, MD||Ann & Robert H Lurie Children's Hospital of Chicago|