Choline Magnesium Trisalicylate and Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia
Condition: 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 in Remission; 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); Recurrent Adult Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Leukemia, Monocytic, Acute; Leukemia, Myelomonocytic, Acute; Leukemia, Megakaryoblastic, Acute; Leukemia, Erythroblastic, Acute
Intervention: choline magnesium trisalicylate; idarubicin; cytarabine; laboratory biomarker analysis
Intervention description: Given PO; Given IV; Given IV; Correlative studies
Intervention MeSH terms: Cytarabine; Choline magnesium trisalicylate; Salicylates; Idarubicin; Choline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial studies how well choline magnesium trisalicylate with
      idarubicin and cytarabine works in treating patients with acute myeloid leukemia. Drugs used
      in chemotherapy, such as choline magnesium trisalicylate, idarubicin, and cytarabine, 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 know whether choline magnesium trisalicylate and
      combination chemotherapy is more effective than combination chemotherapy alone in treating
      patients with acute myeloid leukemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have a diagnosis of non-M3 AML (patients with M3 subtype are excluded);
             determination of the presence of cytogenetic abnormalities will be by standard
             cytogenetics +/- fluorescent-in-situ (FISH) studies; additional molecular analyses for
             nucleophosmin (NPM) mutation and fms-related tyrosine kinase 3 (flt3) internal tandem
             duplication will be obtained as a part of standard care by institutional procedures

          -  Leukemic blast count > 1500/mm^3 of peripheral blood

          -  Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status =<
             3

          -  Total bilirubin < 2 times the institutional upper limit of normal (ULN)

          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) < 3
             times the institutional ULN

          -  Serum creatinine < 1.5 times the institutional ULN

          -  Multi gated acquisition scan (MUGA) or echocardiogram with left ventricular ejection
             fraction (LVEF) > 50%

          -  Women of childbearing potential must have a negative pregnancy test

          -  No uncontrolled psychiatric illness that the principal investigator feels will
             compromise obtaining informed consent from a patient

          -  Patient must be informed of the investigational nature of this study and must give
             written informed consent in accordance with institutional and federal guidelines;
             patients who do not provide informed consent will not be eligible for the study

        Exclusion Criteria:

          -  Any coexisting medical condition or medications precluding full compliance with any of
             the arms of the study

          -  Allergies to any investigational drugs and/or to the chemotherapeutic agents

          -  Allergies to any non-steroidal anti-inflammatory drugs (NSAIDs)/salicylates (e.g.,
             aspirin)

          -  Endoscopically documented upper or lower gastrointestinal (GI) related hemorrhage
             within last 6 months; also, patients with a clinical diagnosis of GI bleeding
             requiring blood transfusions will be excluded