Alvocidib, Cytarabine, and Mitoxantrone in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This randomized phase II trial is studying two different schedules of alvocidib to compare how well they work when given together with cytarabine and mitoxantrone in treating patients with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as alvocidib, cytarabine, and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known which schedule of alvocidib is more effective when given together with cytarabine and mitoxantrone in treating patients with acute myeloid leukemia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Alvocidib; Cytarabine; Mitoxantrone

Criteria

Inclusion Criteria:

• Pathologically confirmed newly diagnosed acute myeloid leukemia (AML) meeting the following criteria:

• Subtypes M0, M1, M2, M4-7

• No acute promyelocytic leukemia (M3)

• At least 50 years of age OR >= 18 years of age with >= 1 of the following poor-risk disease features:

• Antecedent hematologic disorder, including myelodysplastic syndromes (MDS)-related AML or prior myeloproliferative disorder (MPD)

• Treatment-related AML, AML with trilineage dysplasia

• Myeloid sarcoma, myeloid proliferations related to Down Syndrome, or blastic plasmacytoid dendritic cell neoplasm

• AML with trilineage dysplasia

• AML with 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, complex karyotypes [>= 3 unrelated abnormalities]),

• No hyperleukocytosis with >= 50,000 blasts/uL (leukapheresis or hydroxyurea allowed for cytoreduction immediately prior to the first dose of alvocidib)

• No active CNS leukemia

• ECOG performance status 0-2

• Serum creatinine =< 2.0 mg/dL

• ALT/AST =< 5 times upper limit of normal

• Bilirubin =< 2.0 mg/dL

• Not pregnant or nursing

• Negative pregnancy test

• No active uncontrolled infection

• Infection that is under active treatment allowed provided it is controlled with antibiotics

• No other life-threatening illness

• No mental deficits and/or psychiatric history that would preclude giving informed consent or following study requirements

• At least 24 hours since prior leukapheresis or hydroxyurea for cytoreduction

• Prior non-cytotoxic therapies (e.g., thalidomide or lenalidomide, interferon, cytokines, low-dose 5-azacytidine, or low-dose cytoxan) for MDS or MPD allowed

• Prior chemotherapy or bone marrow/stem cell transplantation for non-AML malignancy allowed

• No prior alvocidib

• No other concurrent chemotherapy, radiotherapy, or immunotherapy

• No other concurrent investigational or commercially-available antitumor therapies for AML

• LVEF >= 45%