High-dose Busulfan, High-dose Cyclophosphamide, and Allogeneic Bone Marrow Transplantation for Leukemia, Myelodysplastic Syndromes, Multiple Myeloma and Lymphoma
I. To determine the toxicity and efficacy of the high-dose chemotherapy regimen which
employs busulfan, cyclophosphamide, and allogeneic bone marrow transplantation.
II. To ascertain feasibility (safety) and efficacy of the use of intensive chemotherapy
regimen (busulfan and cyclophosphamide) followed by allogeneic bone marrow transplantation
in patients with leukemia, myelodysplastic syndromes, multiple myeloma, and lymphoma.
HIGH-DOSE CHEMOTHERAPY: Patients receive oral busulfan every 6 hours on days -8 to -5 and
cyclophosphamide IV over 2 hours on days -4 and -3, or -4 to -2 .
TRANSPLANTATION: Patients undergo allogeneic bone marrow transplant IV over 2-3 hours on day
GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine IV over 6 hours on day
-1, over 10 hours twice daily on days 0-20, and then orally every 12 hours beginning on day
21 and continuing for 12 months with taper at 9 months. Patients also receive
methylprednisolone IV or orally beginning on day 8 and continuing for 7 months with taper at
4 months. Some patients may also receive methotrexate IV on days 1, 3 and 6 .
After completion of study treatment, patients are followed up periodically.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
no evidence of leukemia as judged by two peripheral blood smears and two bone marrow aspirates and biopsies. Disease-free and overall survival data will be computed from the day of marrow infusion.
obtained at least one month apart beginning no earlier than two month after marrow infusion
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
United States: Institutional Review Board
|Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|