Phase I/II Trial of Keratinocyte Growth Factor (rHuKGF) to Prevent Acute GVHD in 6/6 HLA=BMT Recipients
3 Years
65 Years
Both
Graft-Vs-Host Disease
Trial Information
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.
Inclusion 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: Prevention
Authority:
United States: Food and Drug Administration
Study ID:
FD-R-2021-01
NCT ID:
NCT00031148
Start Date:
September 2001
Completion Date:
August 2003
Related Keywords:
- Graft-Vs-Host Disease
- Keratinocyte growth factor
- Bone Marrow Transplantation
- Hematopoietic Stem Cell Transplantation
- HLA Antigens
- Transplantation, Homologous
- Recombinant Proteins
- Graft vs Host Disease
Name | Location |
|---|---|
| University of Michigan Cancer Center | Ann Arbor, Michigan 48109 |
