Phase I- II Study of in Vivo Regulatory T Cell Enhancement With Cyclophosphamide and Sirolimus With or Without Vidaza (Azacitidine) for the Treatment of Steroid-refractory Acute Graft-versus-host Disease
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary objective of this study is to determine the response rate of patients treated steroid-refractory GVHD using cyclophospahmide and sirolimus combined with 3 variations of low-dose IL 2 and low-dose Vidaza.
28 days to 100 days post transplant
No
Michele Donato, MD
Principal Investigator
Hackensack University Medical Center
United States: Institutional Review Board
TREG - Pro2219
NCT01453140
August 2011
July 2012
Name | Location |
---|---|
John Theurer Cancer Center at Hackensack University Medical Center | Hackensack, New Jersey 07601 |