NCT00031148

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2001

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 27, 2002

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
Last Updated

March 25, 2015

Status Verified

January 1, 2002

First QC Date

February 26, 2002

Last Update Submit

March 24, 2015

Conditions

Graft-vs-Host Disease

Keywords

Keratinocyte growth factorBone Marrow TransplantationHematopoietic Stem Cell TransplantationHLA AntigensTransplantation, HomologousRecombinant Proteins

Interventions

Recombinant Human Keratinocyte Growth Factor (rHuKGF)DRUG

Eligibility Criteria

Age3 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Fibroblast Growth Factor 7

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Fibroblast Growth FactorsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Sponsor Type
FED

Study Record Dates

First Submitted

February 26, 2002

First Posted

February 27, 2002

Study Start

September 1, 2001

Study Completion

August 1, 2003

Last Updated

March 25, 2015

Record last verified: 2002-01

Locations

US(1)