Keratinocyte Growth Factor to Prevent Acute GVHD

• Status: Completed
• Trial end date: 2003-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: FDA Office of Orphan Products Development
• Treatments: Mitogens

Criteria

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.