Allogeneic HCT Using Nonmyeloablative Host Conditioning With TLI & ATG vs SOC in AML

INCLUSION CRITERIA

≥ 50 years of age and ≤ 75 years of age.
De novo acute myelogenous leukemia (AML), based on FAB and WHO criteria.
Intermediate or unfavorable cytogenetic abnormalities based on Southwest Oncology Group (SWOG) Cytogenetic Criteria.
First morphologic complete remission (CR), or CRp (a complete remission but with low platelets) following 1 or 2 courses of induction therapy, documented no more than 8 weeks prior to the date of enrollment and confirmed at time of enrollment.
Karnofsky Performance Score ≥ 60.
Suitable for non-myeloablative transplantation or best treatment.
Able to understand and willing to sign a written informed consent document.

EXCLUSION CRITERIA

AML with favorable cytogenetic features based on SWOG Cytogenetic Criteria
AML, either treatment-related or MDS-related
Active CNS disease as identified by positive CSF cytospin at time of enrollment.
Prior or concurrent malignancies except localized non-melanoma skin malignancies or treated cervical carcinoma in situ. (EXCEPTION: Cancer treated with curative intent > 5 years previously is allowed. EXCEPTION: Low grade lymphoma is allowed as long as active treatment is not required for control of disease)
Planned for allogeneic transplant using a full-dose conditioning
Life expectancy < 1 year due to diseases other than malignancy
Pregnant or breastfeeding.
HIV-seropositive.
Uncontrolled infection (presumed or documented) with progression after appropriate therapy for greater than one month.
Symptomatic coronary artery disease or uncontrolled congestive heart failure. Left ventricular ejection fraction (LVEF) is not required to be measured, however if measured, exclusion if ejection fraction is < 30%.
Requiring supplementary continuous oxygen. Diffusing capacity of the lungs for carbon monoxide (DLCO) is not required to be measured, however if it is measured, exclusion if DLCO < 35%.
Fulminant liver failure
Cirrhosis with evidence of portal hypertension or bridging fibrosis
Alcoholic hepatitis
Esophageal varices
A history of bleeding esophageal varices
Hepatic encephalopathy
Uncorrectable hepatic synthetic dysfunction evidenced by prolongation of the prothrombin time
Ascites related to portal hypertension
Chronic viral hepatitis with total serum bilirubin > 3 mg/dL
Symptomatic biliary disease