NCT00056875

Brief Summary

This is a single arm dose escalation study of recombinant human keratinocyte growth factor given to patients undergoing allogeneic bone marrow transplantation who are at high risk for graft versus host disease (GVHD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2002

Typical duration for phase_1

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 27, 2003

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
Last Updated

March 25, 2015

Status Verified

February 1, 2006

First QC Date

March 25, 2003

Last Update Submit

March 24, 2015

Conditions

Graft Versus Host Disease

Keywords

graft versus host diseasebone marrow transplantalternative donor

Interventions

recombinant human keratinocyte growth factorDRUG

Eligibility Criteria

Age3 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Eligible for full intensity bone marrow transplant (BMT) conditioning but who lack a 6/6 HLA idential sibling donor

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

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 Officials

  • John Levine, MD

    Univeristy of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 25, 2003

First Posted

March 27, 2003

Study Start

September 1, 2002

Study Completion

June 1, 2005

Last Updated

March 25, 2015

Record last verified: 2006-02

Locations

US(1)