Keratinocyte Growth Factor to Prevent Acute GVHD - Tabular View

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Keratinocyte Growth Factor to Prevent Acute GVHD

This study has been completed.

Study NCT00031148. Last updated on January 31, 2006. Information provided by FDA Office of Orphan Products Development

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	Keratinocyte Growth Factor to Prevent Acute GVHD
Official Title ^†	Phase I/II Trial of Keratinocyte Growth Factor (rHuKGF) to Prevent Acute GVHD in 6/6 HLA=BMT Recipients
Brief Summary	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.
Detailed Description	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 Phase	Phase I, Phase II
Study Type ^†	Interventional
Study Design ^†	Prevention, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Graft-Vs-Host Disease
Intervention ^†	Drug: Recombinant Human Keratinocyte Growth Factor (rHuKGF)
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Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†	72
Start Date ^†	September 2001
Completion Date	August 2003
Eligibility 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.
Gender	Both
Ages	3 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00031148
Organization ID	FD-R-2021-01
Secondary IDs ^††	FD-R-002021-01
Study Sponsor ^†	FDA Office of Orphan Products Development
Collaborators ^††
Investigators ^†
Information Provided By	FDA Office of Orphan Products Development
Verification Date	January 2002
First Received Date ^†	February 26, 2002
Last Updated Date	January 31, 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.