Status:
TERMINATED
Infliximab and Basiliximab for Treatment of Steroid Refractory Acute Graft Versus Host Disease
Lead Sponsor:
Nationwide Children's Hospital
Conditions:
Graft Versus Host Disease
Steroid Refractory GVHD
Eligibility:
All Genders
6-75 years
Phase:
PHASE2
Brief 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 ti...
Detailed Description
Corticosteroids are the standard initial therapy for Acute GvHD (aGVHD) after HSCT (hematopoietic stem cell transplant aka BMT) and 25-41% patients will respond to prednisone (or methylprednisolone) a...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2016
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01485055
Start Date
December 1 2011
End Date
September 26 2016
Last Update
April 5 2019
Active Locations (3)
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1
University of Florida College of Medicine
Gainesville, Florida, United States, 32610
2
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
3
Methodist Healthcare System of San Antonio
San Antonio, Texas, United States, 78229