Allogeneic Peripheral Blood Progenitor Cell Transplantation Using Histocompatible Sibling-Matched Donor Cells After High-Dose Busulfan/Cyclophosphamide as Therapy for Hematologic Malignancies
- Determine the safety and feasibility of using allogeneic peripheral blood progenitor
cell infusions obtained from normal histocompatible sibling donors for reconstituting
bone marrow and immunologic function when given after high-dose
busulfan/cyclophosphamide in patients with a hematologic malignancy.
- Determine the efficacy of this treatment in these patients.
- Determine the ability to mobilize hematopoietic progenitor cells from normal donors
given filgrastim (G-CSF) by determining the hematopoietic progenitor cell content of
allogeneic peripheral blood progenitor cell collections.
- Determine the incidence of engraftment failures in these patients.
- Determine the incidence of severe acute graft-versus-host disease in these patients.
OUTLINE: Patients receive high-dose oral busulfan every 6 hours on days -8 to -5,
cyclophosphamide IV twice a day on days -4 and -3, and cyclosporine IV over 6 hours on day
-1 and then 10 hours on day 0 for 2 doses (allogeneic only). Allogeneic peripheral blood
progenitor cells IV are administered on day 0.
Filgrastim (G-CSF) is administered subcutaneously twice a day beginning 3 hours after
completion of cell infusion and continuing until blood counts recover.
Patients are followed every month for 2 months, every 3 months for 6 months, and then every
6 months until disease progression.
PROJECTED ACCRUAL: A total of 40 patients will be accrued over a 15 month period.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Hematopoietic reconstitution measured daily during transplant
at months 2, 4, 7, and 10, and then every 6 months until disease progression
Hillard M. Lazarus, MD
Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer Center
United States: Federal Government
|Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|