Alvocidib, Cytarabine, and Mitoxantrone Hydrochloride or Cytarabine and Daunorubicin Hydrochloride 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 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 how alvocidib, cytarabine, and mitoxantrone hydrochloride work compared to cytarabine and daunorubicin hydrochloride in treating patients with newly diagnosed acute myeloid leukemia. Alvocidib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cytarabine, mitoxantrone hydrochloride, and daunorubicin hydrochloride 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 whether giving alvocidib, cytarabine, and mitoxantrone hydrochloride is more effective than giving cytarabine and daunorubicin hydrochloride in treating patients with acute myeloid leukemia.

Key facts

Study ID: NCT01349972
Run by: National Cancer Institute (NCI)
People needed: 172
Starts: 2011-04-01
Expected to finish: 2014-05-01
Last updated by the study team: 2017-07-31

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

All adults with established, pathologically confirmed diagnoses of newly diagnosed AML and adults with newly diagnosed AML, excluding newly diagnosed core-binding factor (CBF) AMLs and acute progranulocytic leukemia (APL, M3), will be considered eligible for study
Eastern Cooperative Oncology Group (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
Alanine aminotransferase (ALT)/aspartate aminotransferase (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%
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)
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

You may not qualify if…

Any previous treatment with flavopiridol
Concomitant chemotherapy, radiation therapy, or immunotherapy
Hyperleukocytosis with >= 50,000 blasts/uL; leukopheresis or hydroxyurea may be used immediately prior to study drug administration for cytoreduction; must be stopped 24 hours before first dose of study chemotherapy
CBF AMLs 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 or FISH or molecular testing
Acute Progranulocytic Leukemia (APL, M3)
Active central nervous system (CNS) leukemia
Active, uncontrolled infection; patients with infection under active treatment and controlled with antibiotics are eligible
Active, uncontrolled graft vs. host disease (GVHD) following allogeneic transplant for non-AML condition (e.g. MDS, lymphoid malignancy, aplastic anemia); patients with GVHD controlled on stable doses of immunosuppressants are eligible
Presence of other life-threatening illness
Patients with mental deficits and/or psychiatric history that preclude them form giving informed consent or from following protocol
Pregnant and nursing patients are excluded

Where it is running

Mayo Clinic Scottsdale-Phoenix — Scottsdale, Arizona, United States
Moffitt Cancer Center — Tampa, Florida, United States
Blood and Marrow Transplant Group of Georgia — Atlanta, Georgia, United States
University of Chicago — Chicago, Illinois, United States
University of Maryland/Greenebaum Cancer Center — Baltimore, Maryland, United States
Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States
Mayo Clinic — Rochester, Minnesota, United States
University of North Carolina — Chapel Hill, North Carolina, United States
Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
Baylor University Medical Center — Dallas, Texas, United States
Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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