Keratinocyte Growth Factor to Prevent Acute GVHD

NCT ID: NCT00031148

Last Updated: 2015-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-09-30
• Study Completion Date: 2003-08-31

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.

Conditions

Graft-vs-Host Disease

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

Recombinant Human Keratinocyte Growth Factor (rHuKGF)

Intervention Type: DRUG

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

FDA Office of Orphan Products Development

FED

Sponsor Role: lead

Locations

University of Michigan Cancer Center

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

FD-R-002021-01

Identifier Type: -

Identifier Source: secondary_id

FD-R-2021-01

Identifier Type: -

Identifier Source: org_study_id