Keratinocyte Growth Factor to Prevent Acute GVHD

March 24, 2015 updated by: FDA Office of Orphan Products Development

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

72

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FDA Office of Orphan Products Development

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Study Completion

August 1, 2003

Study Registration Dates

First Submitted

February 26, 2002

First Submitted That Met QC Criteria

February 26, 2002

First Posted (Estimate)

February 27, 2002

Study Record Updates

Last Update Posted (Estimate)

March 25, 2015

Last Update Submitted That Met QC Criteria

March 24, 2015

Last Verified

January 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FD-R-2021-01
  • FD-R-002021-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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