Infliximab and Basiliximab for Treatment of Steroid Refractory Acute Graft Versus Host Disease
Stopped early · Phase 2
Conditions studied: Graft Versus Host Disease, Steroid Refractory GVHD, Acute GVH Disease
In brief
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.
Key facts
- Study ID
- NCT01485055
- Run by
- Nationwide Children's Hospital
- People needed
- 11
- Starts
- 2011-12-01
- Expected to finish
- 2016-09-26
- Last updated by the study team
- 2019-04-05
Who can join
Age: 1 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Any patient with either progressive aGvHD or Steroid Refractory aGvHD after Bone marrow transplant
- Prophylactic GvHD therapy with cyclosporine, tacrolimus, MMF, or sirolimus can be continued.
- Patients with late onset acute GvHD will be eligible
- Patients should have an absolute neutrophil count (ANC) of >500µL
- Patients with renal dysfunction or veno-occlusive disease are eligible
You may not qualify if…
- Patient should not be getting any other experimental therapy for aGvHD
- Patients with active uncontrolled life threatening infection (s) from viral, bacterial, fungal or other organisms will be excluded. Patients with HIV infection will be excluded
- Patients who are pregnant, breast feeding, or if sexually active and unwilling to use effective birth control for the duration of this study will be excluded
- Patients with NYHA Class III or IV heart failure will be excluded
Where it is running
- University of Florida College of Medicine — Gainesville, Florida, United States
- Nationwide Children's Hospital — Columbus, Ohio, United States
- Methodist Healthcare System of San Antonio — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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