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