Stem Cell Transplant to Treat Patients with Favorable or Intermediate Risk, Minimal Residual Disease-Negative, Acute Myeloid Leukemia

Inclusion Criteria

• AML favorable or intermediate ELN risk
• Achieved true 1st complete response (CR) (absolute neutrophil count [ANC] and platelet count > 1,000/ul and 100,000/ul respectively) after first cycle of induction therapy, with no minimal residual disease (MRD)
• No measurable residual disease (MRD) as assessed by flow cytometry after initial induction therapy
• Performance score Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2
• Creatinine < 2.0 mg/dl and calculated by Cockcroft-Gault (CG) formula or 24 hour measured creatinine clearance (CRCL) > 50
• Not pregnant
• Received 1-2 courses of post remission “consolidation” therapy prior to mobilization PBSC
• No MRD by flow, cytogenetics, fluorescence in situ hybridization (FISH) and molecular testing prior to collection of autologous PBSC collection
• Plan is to collect at least 3 x 10^6 CD34+ PBSC/kg cryopreserved; preference is 4-5 X 10^6 CD34 cells/kg

Exclusion Criteria

• Life expectancy is severely limited by diseases other than AML
• Total bilirubin > 2.0 mg/dl or serum glutamic-oxaloacetic transaminase (SGOT)/serum glutamate pyruvate transaminase (SGPT) > 2.5 x upper limit of normal (ULN)
• History of Gilbert’s disease
• Uncontrolled arrhythmias, left ventricular ejection fraction (LVEF) < 50% or corrected diffusion capacity of the lung for carbon monoxide (DLCO) < 50%
• Significant active infection that precludes transplant
• Hepatitis B or C viremia at time of ASCT
• History of central nervous system (CNS) involvement with AML