Idarubicin and High-Dose Cytarabine in Treating Patients With Acute Myeloid Leukemia
Condition: Leukemia
MeSH terms: Leukemia
Intervention: cytarabine; idarubicin
Intervention MeSH terms: Cytarabine; Idarubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 111.0
Sex: All
Minimum age: 16 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: 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 myelomonocytic leukemia (M4); adult erythroleukemia (M6a); adult pure erythroid leukemia (M6b); adult acute myeloid leukemia with 11q23 (MLL) abnormalities; 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); secondary acute myeloid leukemia; untreated adult acute myeloid leukemia

Summary:

      RATIONALE: Drugs used in chemotherapy, such as 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. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

      PURPOSE: This phase II trial is studying how well giving idarubicin together with high-dose
      cytarabine works in treating patients with acute myeloid leukemia.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

        Inclusion criteria:

          -  Newly diagnosed acute myeloid leukemia (AML)

               -  Morphologic proof (bone marrow aspirate smears or touch prep of marrow biopsy) of
                  disease

               -  FAB M0, M1, M2, M4, M5a, M5b, M6a, M6b, and M7 disease

          -  Previously untreated with radiotherapy or chemotherapy

               -  Patients with treatment-related leukemia are eligible even if they have received
                  prior chemotherapy and radiotherapy

          -  Patients with prior myelodysplastic syndrome are eligible

          -  Extramedullary leukemia allowed

          -  AML with lymphoid markers allowed

        Exclusion criteria:

          -  Blastic transformation of chronic myelogenous leukemia

          -  Biphenotypic leukemia

          -  FAB M3 disease (acute promyelocytic leukemia)

        PATIENT CHARACTERISTICS:

          -  Life expectancy ≥ 6 weeks

          -  Total bilirubin < 1.5 g/dL

          -  AST and ALT < 5 times upper limit of normal (ULN)

          -  Creatinine < 1.5 mg/dL OR creatinine clearance > 70 mL/min

          -  Ejection fraction ≥ 50% by MUGA unless decreased ejection fraction is secondary to
             leukemia infiltration

          -  HIV antibody-negative

        PRIOR CONCURRENT THERAPY:

        Inclusion criteria:

          -  See Disease Characteristics

          -  Prior hydroxyurea or corticosteroids allowed

          -  At least 48 hours since prior and no concurrent itraconazole or fluconazole

        Exclusion criteria:

          -  More than 300 mg/m² of prior daunorubicin or equivalent dose of anthracycline