Keratinocyte Growth Factor to Prevent Acute GVHD

Graft-vs-Host Disease Clinical Trial

Official title:

Phase I/II Trial of Keratinocyte Growth Factor (rHuKGF) to Prevent Acute GVHD in 6/6 HLA=BMT Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00031148
• Other study ID #: FD-R-2021-01
• Secondary ID: FD-R-002021-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 26, 2002
• Last updated: March 24, 2015
• Start date: September 2001
• Est. completion date: August 2003

Study information

• Verified date: January 2002
• Source: FDA Office of Orphan Products Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Graft vs Host Disease
• Graft-vs-Host Disease

Intervention

Drug:
• Recombinant Human Keratinocyte Growth Factor (rHuKGF)

Locations

Country	Name	City	State
United States	University of Michigan Cancer Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
FDA Office of Orphan Products Development

Country where clinical trial is conducted

United States,