Trial Information

Protocol for Treatment of Newly Diagnosed High Risk And Relapsed Acute Myeloid Leukemia and Blastic Crisis Chronic Myelogenous Leukemia With Ethyol and High-Dose Cytarabine + Mitoxantron Followed by Maintenance Phase Using Low-Dose ARA-C, rhGM-CSF, Pentoxifylline, Ciprofloxacin and Decadron

OBJECTIVES: I. Assess the effects of amifostine on the response to remission induction
therapy and consolidation with cytarabine and mitoxantrone in patients with poor prognosis
acute myeloid leukemia (AML), relapsed AML, and blastic phase chronic myelogenous leukemia
(CML). II. Assess the effects of amifostine on the biology of AML and CML cells in vivo in
this patient population.

OUTLINE: Patients receive treatment prior to induction therapy on protocols CYL 90-03 and
CYL 97-59. Induction therapy consists of amifostine IV on days 1 and 5 and three times a
week from days 6 to 28. Fifteen minutes after amifostine on days 1 and 5, patients receive
cytarabine IV over 3 hours at hour 0 and hour 12 and mitoxantrone IV over 1 hour at hour 15.
Patients who do not enter remission receive a second course of induction therapy. Patients
with persistent AML following a second course are removed from the study. Patients who
achieve a complete response (CR), clinical CR, or remission in bone marrow but without
hematologic recovery or who return to myelodysplastic syndrome receive consolidation
therapy. Consolidation therapy consists of amifostine IV on days 1 and 5 and then three
times a week until blood counts recover or day 30, whichever comes first. Patients also
receive cytarabine and mitoxantrone as in induction therapy. Patients receive a second
course of consolidation therapy beginning 1 week after blood counts recover. After
completion of consolidation therapy, patients are enrolled on protocol MDS 97-53.

PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study.