Trial Information

Autologous Bone Marrow Transplantation for Non-M3 Acute Myeloid Leukemia (AML) in First Remission in Patients

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.