Back to resultsRecombinant Human Keratinocyte Growth Factor in Unrelated and Related Transplants
Primary Purpose
Graft Versus Host Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
recombinant human keratinocyte growth factor
Sponsored by
About this trial
This is an interventional prevention trial for Graft Versus Host Disease focused on measuring graft versus host disease, bone marrow transplant, alternative donor
Eligibility Criteria
Eligible for full intensity bone marrow transplant (BMT) conditioning but who lack a 6/6 HLA idential sibling donor
Sites / Locations
- University of Michigan Cancer Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00056875
Brief Title
Recombinant Human Keratinocyte Growth Factor in Unrelated and Related Transplants
Official Title
Safety and Efficacy of Recombinant Human Keratinocyte Growth Factor in Unrelated and Related Transplants
Study Type
Interventional
2. Study Status
Record Verification Date
February 2006
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Michigan
4. Oversight
5. Study Description
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).
Detailed Description
Completion date provided represents the completion date of the grant per OOPD records
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft Versus Host Disease
Keywords
graft versus host disease, bone marrow transplant, alternative donor
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
recombinant human keratinocyte growth factor
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Eligible for full intensity bone marrow transplant (BMT) conditioning but who lack a 6/6 HLA idential sibling donor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Levine, MD
Organizational Affiliation
Univeristy of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Recombinant Human Keratinocyte Growth Factor in Unrelated and Related Transplants
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