Phase II Study of IV Busulfan Combined With 12 cGy of Fractionated Total Body Irradiation (FTBI) and Etoposide (VP-16) as a Preparative Regimen for Allogeneic Bone Marrow Transplantation for Patients With Advanced Hematological Malignancies
- To determine the efficacy of a preparative regimen comprising dose targeted busulfan,
etoposide, and fractionated total-body irradiation followed by allogeneic hematopoietic
stem cell or bone marrow transplantation in patients with advanced hematologic
- To determine the efficacy of this regimen in patients with acute myeloid leukemia in
first remission with unfavorable cytogenetics.
- To evaluate the early and late toxicities of this regimen.
- Preparative chemotherapy regimen: Patients receive busulfan IV over 2 hours once every
6 hours on days -14 to -8 for a total of 16 doses and etoposide IV on day -3.* NOTE:
*Patients also receive oral or IV dilantin 1-3 times daily on days -18 to -5 for
prophylaxis of grand mal seizures.
- Fractionated total-body irradiation (FTBI): Patients undergo FTBI on days -7 to -4 for
a total of 10 fractions.
- Allogeneic transplantation: Patients undergo allogeneic peripheral blood stem cell
transplantation or bone marrow transplantation on day 0.
- Graft-versus-host disease (GVHD) prophylaxis: Patients receive cyclosporine IV or
orally on days -1 to 50 followed by a taper to day 180 in the absence of GVHD. Patients
also receive mycophenolate mofetil orally or IV over 2 hours twice daily on days 0-27,
followed by a taper until day 56.
After completion of study treatment, patients are followed annually for 2 years.
Masking: Open Label, Primary Purpose: Treatment
Anthony S. Stein, MD
Beckman Research Institute
United States: Federal Government