Autologous Transplant as Treatment for Favorable or Intermediate Risk MRD-Negative AML Patients after Initial Induction Therapy
Ages Eligible for Study: 18 Years to 69 Years (Adult, Older Adult)
AML favorable or intermediate European LeukemiaNet (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
Received 1-2 courses of post remission "consolidation" therapy prior to mobilization PBSC
No MRD by flow, cytogenics, 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.
Other eligibility criteria may apply.
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)
Significant active infection that precludes transplant
Hepatitis B or C viremia at time of ASCT
History of central nervous system (CNS) involvement with AML
Other exclusion criteria may apply.