Alvocidib (Flavopiridol), Ara-C and Mitoxantrone (FLAM) Versus "7+3" for Newly (AML)

The purpose of this research study is to compare two different chemotherapy regimens to try
to find out which way might be safer and/or more effective against Acute Myelogenous
Leukemia (AML). This is a Phase II study. Phase II studies are designed to examine whether
specific drugs or drug combinations have activity against a specific type of cancer. The
combination of flavopiridol with ara-C and mitoxantrone (FLAM) is an experimental
combination for treating newly diagnosed AML with high risk features. In this study the
flavopiridol, ara-C and mitoxantrone is being compared to traditional chemotherapy used to
treat newly diagnosed AML of ara-C and daunorubicin (7+3).

Inclusion:

Tumor Types: All Adults age > 18 years and < 70 years with Newly Diagnosed, Intermediate
Risk or Poor-Risk AML.

Performance Status: ECOG Performance Status 0-3, patients > 65 years of age must have ECOG
performance status < 2 prior to developing leukemic symptoms. Organ Function Low blood
cell counts (ie, platelets, RBC's, WBC's)are allowed Normal kidney and liver function
required Normal heart function required Allowed Prior Therapy: Hydroxyurea, non-cytotoxic
therapy for MDS or MPN (e.g., thalidomide or lenalidomide, interferon, cytokines,
5-azacytidine or decitabine, histone deacetylase inhibitors, low-dose cytoxan, tyrosine
kinase or dual TK/src inhibitors) will be eligible for this trial.

Exclusion Criteria:

Patients cannot have been treated previously with flavopiridol. Patients cannot be
diagnosed with core-binding factor AML's. Patients cannot have APL, >50,000blasts/uL,
Patients cannot have simultaneous treatment with other chemotherapy, radiation, or
immunotherapy.

Patient cannot have uncontrolled infection Patient cannot have active CNS leukemia, active
GVHD, or other life threatening illnesses.

The patient cannot be pregnant or nursing.