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

Completed · Phase 2

Conditions studied: Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome, Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b), Secondary Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia

In brief

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.

Key facts

Study ID: NCT00795002
Run by: National Cancer Institute (NCI)
People needed: 78
Starts: 2008-11-01
Expected to finish: 2012-09-01
Last updated by the study team: 2018-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

Where it is running

Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore, Maryland, United States
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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