Hematopoietic Stem Cell Transplantation for the Treatment of Older Patients With Acute Myelogenous Leukemia
Inclusion Criteria:
For Study Registration:
- Age 55 - 70 years.
- Subjects diagnosed with AML (> 20% myeloblasts).
For Proceeding to Transplant:
- Subjects must be in either complete remission (CR) or partial remission (PR) within
14 days prior to admission.
- Subjects must be > 21 days since completion of prior systemic chemotherapy or
radiation therapy (including craniospinal XRT), prior to admission .
- Organ function requirements for a reduced intensity (FluBu2) regimen (must be met
within 21 days of admission):
- Cardiac: LV Ejection Fraction > 40% on MUGA or Echocardiogram.
- Pulmonary: FEV1 and FVC > 40% predicted, DLCO > 40% of predicted.
- Renal: Serum creatinine < 2.0 mg/dl. Not on hemodialysis or continuous
veno-venous filtration (CVVH).
- Hepatic: serum total bilirubin < 3.0 mg/dl and AST / ALT < 4x ULN
- Karnofsky > 60%.
- Organ function requirements for a full intensity (FluBu4) regimen (must be met within
21 days of admission):
- Cardiac: LV Ejection Fraction > 40% on MUGA or Echocardiogram.
- Pulmonary: FEV1 and FVC > 50% predicted, DLCO (corrected for hemoglobin) >
50% of predicted.
- Renal: serum creatinine < 2.0 mg/dl. Not on hemodialysis or continuous
veno-venous filtration (CVVH)
- Hepatic: serum total bilirubin < 3.0 mg/dl and AST / ALT < 4x ULN.
- Karnofsky > 60%.
Exclusion Criteria:
For Study Registration:
- Subjects with M3 AML (FAB classification)
For Proceeding to Transplant:
- Subjects who exhibit signs of progressive disease (> 20% blasts) within 14 days prior
to admission for transplant
- Patients with an uncontrolled viral or fungal infection within the prior 28 days.
- Patients who are HIV1 or HIV2 positive.
- Uncontrollable medical or psychiatric disorder