Randomized Phase II Trial of Timed Sequential Therapy (TST) With Alvocidib (Flavopiridol), Ara-C and Mitoxantrone (FLAM) vs. "7+3" for Adults Age 70 and Under With Newly Diagnosed Acute Myelogenous Leukemia (AML)

Inclusion Criteria:

- All adults with established, pathologically confirmed newly diagnosed acute myeloid
leukemia (AML)

- Adults (≥ 18 years and ≤ 70 years of age) with newly diagnosed AML

- Excluding newly diagnosed core-binding factor (CBF) AML and acute
progranulocytic leukemia (APL, M3)

- CBF AML associated with t(8;21) or M4eo subtype (inv[16] or t[16;16]), as
diagnosed by morphologic criteria, flow cytometric characteristics, and
rapid cytogenetics, fluorescence in situ hybridization (FISH), or molecular
testing

- Newly diagnosed AML, subtypes M0, 1, 2, 4-7 but excluding M3 (APL), including those
with the following poor risk features:

- Antecedent hematologic disorder including myelodysplasia (MDS)-related AML
(MDS/AML) and prior myeloproliferative disorder (MPD)

- Treatment-related myeloid neoplasms (t-AML/t-MDS)

- Myeloid sarcoma, myeloid proliferations related to Down Syndrome, and blastic
plasmacytoid dendritic cell neoplasm

- AML with multilineage dysplasia (AML-MLD)

- Adverse cytogenetics (defined as -5/-5q; -7/-7q; abnormal 3q, 9q, 11q, 20q, 21q,
or 17p; t(6;9); t(9;22); trisomy 8; trisomy 13; trisomy 21; and complex
karyotypes (≥ 3 unrelated abnormalities)

- No active CNS leukemia

- ECOG performance status (PS) 0-3

- Patients ≥ 65 years of age must have ECOG PS ≤ 2 prior to developing leukemic
symptoms

- Serum creatinine ≤ 2.0 mg/dL

- ALT/AST ≤ 5 times upper limit of normal (ULN) (unless leukemic infiltration)

- Total bilirubin ≤ 2.0 mg/dL (unless Gilbert disease, hemolysis, or leukemia)

- Left ventricular ejection fraction ≥ 45%

- No hyperleukocytosis with ≥ 50,000 blasts/μL

- No active, uncontrolled infection

- Patients with infection under active treatment and controlled with antibiotics
are eligible

- No presence of other life-threatening illness

- No patients with mental deficits and/or psychiatric history that preclude them from
giving informed consent or from following protocol

- Not pregnant or nursing

- No active uncontrolled graft-vs-host disease following allogeneic transplantation for
non-AML condition (e.g., MDS, lymphoid malignancy, or aplastic anemia); patients with
GVHD controlled on stable doses of immunosuppressants are eligible

- Patients who have received hydroxyurea alone or have received non-cytotoxic therapies
previously for myelodysplasia (MDS) or myeloproliferative disorder (MPD) (e.g.,
thalidomide or lenalidomide, interferon, cytokines, 5-azacytidine or decitabine,
histone deacetylase inhibitors, low-dose cyclophosphamide [cytoxan], tyrosine kinase
[TK] or dual TK/src inhibitors) will be eligible for this trial

- At least 24 hours since prior leukopheresis or hydroxyurea for cytoreduction

- No prior alvocidib (flavopiridol)

- No other concomitant chemotherapy, radiotherapy, or immunotherapy