Graft vs Host Disease Clinical Trial
Official title:
A Pilot Study of Alpha-1-Antitrypsin (AAT) in Steroid Refractory Acute Graft vs Host Disease
This clinical trial will study the safety and efficacy of using the drug Zemaira, an Alpha
1-Antitrypsin (AAT) medication (also known as an Alpha1-Proteinase Inhibitor [Human]) for the
treatment of steroid refractory GVHD.
For bone marrow transplant patients, the most common, serious complication is Graft vs Host
Disease (GVHD), which at its most severe is a life-threatening, complication and a
significant cause of treatment related death, following stem cell transplantation. GVHD is a
major obstacle to the overall success of transplant treatment, a strategy that would
otherwise provide the possibility of a cure for patients with blood cancers or severe blood
disorders. GVHD primarily affects the skin, gut, and liver of the recipient, and involves the
interaction of the recipient's (the host's) cells and tissues with the donor's immune system
cells that see the host tissues as foreign, and attack the host's cells resulting in tissue
and organ damage.
The severity of acute GvHD ranges from mild to severe, and for patients who don't respond to
steroid therapy, the complication is nearly always fatal, either from organ damage or
opportunistic infection as a consequence of high dose, steroid treatments.
There is currently no known effective therapy for patients with acute graft vs host disease
that's refractory (nonresponsive) to steroid therapy. As stated earlier,the overwhelming
majority of these patients may ultimately die from infection. The incidence of acute GvHD
that requires intervention, is higher for unrelated donor transplants, the most common
treatment option available, and therefore, these patients are at higher risk for treatment
related complications from GVHD. Approximately 20,000 unrelated donor transplants are
performed each year. The magnitude of this problem then is significant for patients who
otherwise might be cured of their blood cancer or disease.
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