Busulfan, Etoposide, and Total-Body Irradiation Followed by Autologous Stem Cell Transplant and Aldesleukin in Treating Patients With Acute Myeloid Leukemia in First Remission

• Efficacy of preparative therapy as measured by 2- and 5-year disease-free survival [ Designated as safety issue: No ]
  
• Toxicity of preparative therapy [ Designated as safety issue: Yes ]
  
• Feasibility of administration and ability to tolerate aldesleukin after transplantation [ Designated as safety issue: No ]
  

• Effect of cytogenetics, WBC at presentation, targeted busulfan dose, and number of courses of induction therapy required to achieve remission on possible prognostic factors for relapse, disease-free survival, and overall survival [ Designated as safety issue: No ]
  

OBJECTIVES:

• To evaluate the efficacy and toxicity of a preparative regimen comprising busulfan, etoposide, and fractionated total-body irradiation followed by autologous stem cell transplantation and aldesleukin after treatment with consolidation therapy comprising high-dose cytarabine with or without idarubicin in patients with acute myeloid leukemia in first remission.
• To estimate the long-term disease-free survival of patients treated with this regimen.
• To further evaluate the effect of prognostic factors (e.g., cytogenetics, WBC at presentation, and number of courses of induction therapy required to achieve remission) on the outcome of autologous stem cell transplantation and targeted busulfan dose.

OUTLINE:

• Consolidation therapy: Patients who received prior consolidation therapy are evaluated to determine the need for additional consolidation therapy. Patients who have not received prior consolidation therapy receive high-dose cytarabine IV over 3 hours every 12 hours on days 1-4 and idarubicin* IV over 5-10 minutes on days 1-3.

NOTE: *Patients with good risk cytogenetics t(8;21), inv(16), or t(16;16) or patients who received > 200 mg/m² of anthracycline do not receive idarubicin.

• Stem cell collection: All patients receive filgrastim (G-CSF) IV or subcutaneously (SC) twice daily beginning 7 days after completion of high-dose cytarabine and continuing until peripheral blood stem cell (PBSC) collection is completed. Patients who do not have an adequate number of PBSCs collected also undergo bone marrow collection.
• Preparative regimen: Patients receive busulfan IV over 2 hours on days -13 and -11 to -7 and etoposide IV on day -2. Patients also undergo fractionated total-body irradiation on days -6 to -3 for a total of 8-10 fractions.
• Autologous stem cell transplantation: Patients undergo autologous stem cell transplantation using PBSCs (with or without bone marrow) on day 0. Patients receive G-CSF IV or SC daily beginning on day 5 and continuing until blood counts recover.
• Interleukin therapy: Within 100 days post-transplantation, patients receive aldesleukin IV continuously on days 1-4 and 9-18.

After completion of study treatment, patients are followed periodically.