Keratinocyte Growth Factor to Prevent Acute GVHD
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|ClinicalTrials.gov Identifier: NCT00031148|
Recruitment Status : Completed
First Posted : February 27, 2002
Last Update Posted : March 25, 2015
|Condition or disease||Intervention/treatment||Phase|
|Graft-vs-Host Disease||Drug: Recombinant Human Keratinocyte Growth Factor (rHuKGF)||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||72 participants|
|Official Title:||Phase I/II Trial of Keratinocyte Growth Factor (rHuKGF) to Prevent Acute GVHD in 6/6 HLA=BMT Recipients|
|Study Start Date :||September 2001|
|Study Completion Date :||August 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00031148
|United States, Michigan|
|University of Michigan Cancer Center|
|Ann Arbor, Michigan, United States, 48109|