STUDY RATIONALE:

      The optimal treatment regimen for relapsed/refractory acute myeloid leukemia (AML) is
      unknown. Although several chemotherapy options are available, there is no universally
      accepted regimen to date. One such regimen is CLAG-M (Cladribine, Cytarabine, Mitoxantrone,
      G-CSF) that has been frequently used at our center. However, it is difficult to predict which
      patients are likely to respond to CLAG-M or experience treatment-related toxicities. In
      patients with newly diagnosed AML, studies have demonstrated that achievement of minimal
      residual disease negative CR is associated with a better overall survival. However, this has
      not been clearly studied in patients with relapsed-refractory AML. Through this study, we aim
      to demonstrate the influence of achieving MRD negative CR on survival of patients with
      relapsed/refractory AML treated with CLAG-M. In addition to the conventionally used
      predictive factors, we aim to incorporate pharmacogenomics to assess the efficacy and
      toxicity of therapy.

      PRIMARY OBJECTIVE:

      To determine the complete remission (CR) rate and achievement of minimal residual disease
      (MRD) negativity after treatment with salvage CLAG-M chemotherapy regimen in patients with
      relapse/refractory and secondary AML.

      SECONDARY OBJECTIVES:

        1. To determine the progression free survival (PFS) and overall survival (OS) of patients
           treated with CLAG-M chemotherapy regimen.

        2. To study the pharmacogenomics of patients receiving CLAG-M chemotherapy and determine
           its influence on survival, CR rate and MRD negativity.

        3. Determination of disease- or patient-related factors that predict MRD negativity and
           survival with CLAG-M.