Addition of Etanercept and Extracorporeal Photopheresis (ECP) to Standard Graft-Versus-Host Disease (GVHD) Prophylaxis in Stem Cell Transplant

PHASE2CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

March 31, 2009

Primary Completion Date

January 31, 2012

Study Completion Date

April 30, 2016

Conditions
Graft Versus Host Disease
Interventions
PROCEDURE

stem cell transplant

reduced intensity, matched unrelated donor stem cell transplant

DRUG

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"

DRUG

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.

DRUG

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)

DRUG

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."

Trial Locations (1)

48109

University of Michigan Cancer Center, Ann Arbor

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Mallinckrodt

INDUSTRY

collaborator

Amgen

INDUSTRY

lead

University of Michigan Rogel Cancer Center

OTHER