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Home > "K" Clinical Trials Conditions > Keratinocyte Growth Factor to Prevent Acute GVHD  Keratinocyte Growth Factor to Prevent Acute GVHD
Keratinocyte Growth Factor to Prevent Acute GVHD
For Condition: Graft-vs-Host Disease
Status: Recruiting
Sponsor(s): FDA Office of Orphan Products Development ,
Synopsis: This is a study to determine the safety and efficacy of keratinocyte growth factor (KGF) to prevent acute graft-versus-host disease (GVHD) in patients undergoing allogeneic bone marrow (BM) or peripheral blood progenitor cell (PBPC) transplantation.
Details: 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.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
Minimum Age/Maximum Age: 3 Years/65 Years
Genders: Both
Protocol Entry Criteria: Inclusion criteria: - Diagnosis of a hematological malignancy, including myelodysplastic syndromes. - Eligible for cyclophosphamide and total body irradiation conditioning therapy or busulphan and cyclophosphamide conditioning therapy. - Must have a 6/6 human leukocyte antigens (HLA)-matched family member donor. - Women must be post-menopausal, sterile, or using effective contraception for 1 month before, during, and for 2 months after study. - Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Exclusion criteria: - T-cell depletion for GVHD prophylaxis. - Active hepatitis. - Pre-existent inflammatory bowel disease requiring active therapy. - Active uncontrolled infection. - Prior bone marrow or peripheral blood stem cell (PBSC) transplantation. - Documented hypersensitivity to rHuKGF. - Prior enrollment to a study of rHuKGF. - HIV-positive. - Pregnant or nursing. - Active chronic skin disease requiring therapy.
Total Enrollment: 72
Location and Contact Information:
University of Michigan Cancer Center *Recruiting*
Ann Arbor, Michigan, 48109
United States
Recruiting James Ferrara 734-615-1340
Additional Information:
Study ID Numbers: FD-R-2021-01; FD-R-002021-01
Study Start Date: September 2001
Record last reviewed: January 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031148
Other Graft-Vs-Host Disease Studies:
1. Keratinocyte Growth Factor to Prevent Acute GVHD
2. Research Study of Visilizumab for Treatment of Glucocorticoid- Refractory Graft Versus Host Disease
Related Studies:
Other Graft-vs-Host Disease Clinical Trials
Other Michigan Clinical Trials
Other Ann Arbor Clinical Trials
Keratinocyte Growth Factor to Prevent Acute GVHD
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