Phase I/II Trial of Keratinocyte Growth Factor (rHuKGF) to Prevent Acute GVHD in 6/6 HLA=BMT Recipients
GVHD remains the major complication of allogeneic BM transplantation and is initiated
during the conditioning of the recipient for transplant when the host tissues are damaged.
Research has demonstrated that the gastrointestinal (GI) tract is a critical organ in GVHD
pathophysiology. Agents that protect the GI tract may provide prophylaxis against the
cytokine cascade and can lead to a reduced incidence and severity of GVHD. KGF is a protein
that stimulates the growth of epithelial cells including those of the GI tract. KGF can
protect the GI tract, prevent GVHD, and preserve donor T-cell function.
Patients will receive standard GVHD prophylaxis in addition to the study drug. Overall GVHD
will be graded weekly during the first 2 months after transplant, then every other week to
Day 100. Response to therapy will be measured through the use of severity indices, physical
exam, and laboratory serum values.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: Prevention
United States: Food and Drug Administration
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