Reduced Intensity Regimen vs Myeloablative Regimen for Myeloid Leukemia or Myelodysplastic Syndrome (BMT CTN 0901)

Inclusion Criteria:

• Age equal or less than 65 years old and equal to or greater than 18 years old.
• Patients with the diagnosis of MDS or AML with fewer than 5% myeloblasts in the bonemarrow and no leukemic myeloblasts in the peripheral blood on morphologic analysisperformed within 30 days of start of the conditioning regimen enrollment.
• For patients receiving treatment of their MDS or AML prior to transplantation:a)Interval between the start of the most recent cycle of conventional cytotoxicchemotherapy and enrollment must be at least 30 days; b)Interval between completingtreatment with a hypomethylating agent or other non-cytotoxic chemotherapy andenrollment must be at least 10 days.
• Patients must have a related or unrelated bone marrow or peripheral blood donor who ishuman leukocyte antigen (HLA)-matched at 7 or 8 of 8 HLA-A, -B, -C and -DRB1 at highresolution using DNA-based typing.
• HCT-Specific Comorbidity Index Score (HCT-CI) less than or equal to 4.
• Organ function: a) Cardiac function: Ejection fraction greater than or equal to 40%;b) Hepatic function: total bilirubin less than or equal to 2 times the upper limit ofnormal and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) lessthan or equal to 3 times the upper limit of normal.; c)Pulmonary function: Diffusingcapacity of the lung for carbon monoxide (DLCO) greater than or equal to 40% andforced expiratory volume in one second (FEV1) greater than or equal to 50% (correctedfor hemoglobin).
• Creatinine clearance greater than or equal to 50mL/min based on the Cockcroft-Gaultformula.
• Signed informed consent.

Exclusion Criteria:

• Prior allograft or prior autograft.
• Symptomatic coronary artery disease.
• Leukemia involvement in the central nervous system (CNS) within 4 weeks of enrollmentfor patients with a history of prior CNS leukemia involvement (i.e., leukemic blastspreviously detected in the cerebral spinal fluid).
• Karnofsky Performance Score less than 70.
• Patients receiving supplemental oxygen.
• Planned use of donor lymphocyte infusion (DLI) therapy.
• Patients with uncontrolled bacterial, viral or fungal infections (undergoingappropriate treatment and with progression of clinical symptoms).
• Patients seropositive for the human immunodeficiency virus (HIV).
• Patients with prior malignancies, except resected basal cell carcinoma or treatedcervical carcinoma in situ. Cancer treated with curative intent greater than 5 yearspreviously. Cancer treated with curative intent less than 5 years previously will notbe allowed unless approved by the Protocol Officer or one of the Protocol Chairs.
• Females who are pregnant or breastfeeding.
• Fertile men and women unwilling to use contraceptive techniques during and for 12months following treatment.