Infliximab and Basiliximab for Treatment of Steroid Refractory Acute Graft Versus Host Disease

Summary

Acute Graft Versus Host Disease (GVHD) is a serious medical condition that is a common development after Bone Marrow Transplant (BMT). Acute GVHD happens when the donor cells attack and damage your tissues and organs after transplant. Acute GVHD often causes: Skin rashes, nausea, vomiting, abdominal pain, diarrhea (may have blood), liver damage that can cause inflammation in the liver or jaundice (yellowing of the skin or eyes), damage to other organs Steroids are the first line of treatment for acute GVHD. About a quarter of the patients that develop acute GVHD may not respond to steroid and have steroid refractory GVHD (SR-aGVHD). Patients with SR-aGVHD may need other medications. SR-aGVHD, is a potentially life threatening condition. There is no standard treatment and it may not respond to treatment. The goals of this study are to find out if Infliximab and basiliximab can treat SR-aGVHD. Participants in this study will receive combination therapy (2 drugs: infliximab and basiliximab) once a week for four weeks.

Timeline

Start

2011-12

Primary completion

2015-12

Completion

2016-09-26

Publications

• Background Srinivasan R, Chakrabarti S, Walsh T, Igarashi T, Takahashi Y, Kleiner D, Donohue T, Shalabi R, Carvallo C, Barrett AJ, Geller N, Childs R. Improved survival in steroid-refractory acute graft versus host disease after non-myeloablative allogeneic transplantation using a daclizumab-based strategy with comprehensive infection prophylaxis. Br J Haematol. 2004 Mar;124(6):777-86. doi: 10.1111/j.1365-2141.2004.04856.x.
• Background Rao K, Rao A, Karlsson H, Jagani M, Veys P, Amrolia PJ. Improved survival and preserved antiviral responses after combination therapy with daclizumab and infliximab in steroid-refractory graft-versus-host disease. J Pediatr Hematol Oncol. 2009 Jun;31(6):456-61. doi: 10.1097/MPH.0b013e31819daf60.

Drugs

Indications