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Keratinocyte Growth Factor to Prevent Acute GVHD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00031148
Recruitment Status : Completed
First Posted : February 27, 2002
Last Update Posted : March 25, 2015
Information provided by:
FDA Office of Orphan Products Development

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.

Condition or disease Intervention/treatment Phase
Graft-vs-Host Disease Drug: Recombinant Human Keratinocyte Growth Factor (rHuKGF) Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 72 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Prevention
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

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00031148

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United States, Michigan
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
FDA Office of Orphan Products Development

Layout table for additonal information Identifier: NCT00031148    
Other Study ID Numbers: FD-R-2021-01
First Posted: February 27, 2002    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: January 2002
Keywords provided by FDA Office of Orphan Products Development:
Keratinocyte growth factor
Bone Marrow Transplantation
Hematopoietic Stem Cell Transplantation
HLA Antigens
Transplantation, Homologous
Recombinant Proteins
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action