Test Extracorporeal Photopheresis (ECP) Treatment Before/After Allogeneic Bone Marrow Transplant (BMT) or Peripheral Blood Stem Cell (PBSC) Transplant to Prevent Graft Versus Host Disease

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

June 30, 2010

Primary Completion Date

August 31, 2014

Study Completion Date

August 31, 2015

Conditions
Stem Cell Leukemia of Unclear LineageGraft Versus Host Disease
Interventions
DRUG

extracorporeal photopheresis

"Patients will receive 2 ECP treatments prior to the commencement of the high dose chemotherapy and then for two consecutive days every two weeks starting from post engraftment (ANC \> 500) up to day 90 (total of 10 treatments). This may be given as an outpatient procedure.~The dose of UVADEX® used to inoculate these cells will be calculated based on the treatment volume collected during the plasma/buffy coat collection process, using the following formula:~Treatment Volume in mL X 0.017 of UVADEX® (20 mcg/ml) required for administration into the recirculation bag = Amount of UVADEX® (in mLs) required for administration into the recirculation bag.~After the cells are inoculated with UVADEX®, the buffy coat/plasma suspension is irradiated with ultraviolet-A light and then re-infused back into the patient."

Trial Locations (1)

66160

University of Kansas Medical Center, Kansas City

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Mallinckrodt

INDUSTRY

lead

University of Kansas Medical Center

OTHER