PRIMARY OBJECTIVES:

      I. To evaluate the feasibility of randomizing medically less fit adults with newly diagnosed
      acute myeloid leukemia (AML) or analogous myeloid neoplasms to either intensive or
      non-intensive induction and post remission chemotherapy.

      SECONDARY OBJECTIVES:

      I. To evaluate the attitude of patients and physicians toward randomization and explore
      reasons for treatment preference.

      II. To evaluate whether the ability to assess fitness for intensive chemotherapy can be
      improved by an augmented treatment-related mortality (TRM) score that includes additional
      (co-morbidity) factors, and to compare the ability of physicians and the prediction
      algorithm(s) to assess the likelihood of early death.

      III. To compare, within the limits of a pilot study, response, duration of response, and
      survival between patients receiving intensive and those receiving non-intensive chemotherapy.

      IV. To describe the impact of treatment intensity on quality of life of patients undergoing
      chemotherapy for newly diagnosed AML.

      V. To describe the impact of treatment intensity on medical resource utilization and care
      cost of patients undergoing chemotherapy for newly diagnosed AML.

      OUTLINE: Patients agreeable to randomization are randomized to 1 of 2 treatment arms.
      Patients not agreeable to randomization receive treatment based on their preference.

      ARM I (HIGHER-DOSE):

      INDUCTION: Patients receive granulocyte colony-stimulating factor (G-CSF) subcutaneously (SC)
      on days 0-5, higher dose cladribine intravenously (IV) over 2 hours on days 1-5, higher dose
      cytarabine IV over 2 hours on days 1-5, and higher dose mitoxantrone IV over 60 minutes on
      days 1-3. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease
      progression or unacceptable toxicity.

      CONSOLIDATION: Patients who achieve complete response (CR)/CR with incomplete count recovery
      (CRi) with up to 2 courses of Induction receive G-CSF, cladribine, and cytarabine as in
      Induction. Courses repeat every 6 weeks for up to 4 courses in the absence of disease
      progression or unacceptable toxicity.

      ARM II (LOWER-DOSE):

      INDUCTION: Patients receive G-CSF SC on days 0-5, lower dose cladribine IV over 2 hours on
      days 1-5, lower dose cytarabine IV over 1 hour on days 1-5, and lower dose mitoxantrone IV
      over 60 minutes on days 1-3. Treatment repeats every 6 weeks for up to 12 courses in the
      absence of disease progression or unacceptable toxicity.

      CONSOLIDATION: Patients who achieve complete response (CR)/CR with incomplete count recovery
      (CRi) with up to 6 courses of Induction receive G-CSF, cladribine, and cytarabine as in
      Induction. Courses repeat every 6 weeks for up to 12 courses in the absence of disease
      progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up periodically for 5 years.