Keratinocyte Growth Factor to Prevent Acute GVHD

Completed · Phase 1/Phase 2

Conditions studied: Graft-vs-Host Disease

In brief

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.

Key facts

Study ID

NCT00031148

Run by

FDA Office of Orphan Products Development

People needed

72

Starts

2001-09-01

Expected to finish

2003-08-01

Last updated by the study team

2015-03-25

Who can join

Age: 3 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.