48
Participants
Start Date
March 31, 2009
Primary Completion Date
January 31, 2012
Study Completion Date
April 30, 2016
stem cell transplant
reduced intensity, matched unrelated donor stem cell transplant
tacrolimus (standard GVHD prophylaxis)
"Tacrolimus(or cyclosporine when necessary)~Tacrolimus will begin on day -3, IV or oral.~Target trough level for tacrolimus is 8-12 ng/ml.~In the absence of GVHD, tacrolimus tapering will begin on day +56 post transplant"
mycophenolate (standard GVHD prophylaxis)
Mycophenolate will begin on day 0 at 10 mg/kg/dose (up to 1 gram per dose) every 8 hours orally or intravenously and will continue until day 28.
etanercept
Etanercept will be given at a dose 0.4 mg/kg (actual weight) up to a maximum dose of 25 mg, subcutaneously, twice weekly from day 0 to day 56 (16 doses)
methoxsalen
"Methoxsalen (UVADEX) treatments by Extracorporeal photopheresis (ECP) will be started day +28 post transplant and given weekly.~On day +70 post transplant ECP frequency will be given every other week.~On day +100 post transplant ECP will be given monthly until day +180 and stopped."
University of Michigan Cancer Center, Ann Arbor
Collaborators (2)
Mallinckrodt
INDUSTRY
Amgen
INDUSTRY
University of Michigan Rogel Cancer Center
OTHER