• Survival at day 100, 1 year, and 2 years [ Designated as safety issue: No ]
  

• Hematopoietic engraftment [ Designated as safety issue: No ]
  
• Toxicity as measured by NCI CTACE version 3.0 [ Designated as safety issue: Yes ]
  
• Acute graft-vs-host disease (GVHD) and chronic GVHD [ Designated as safety issue: Yes ]
  
• Survival [ Designated as safety issue: No ]
  

OBJECTIVES:

• To assess the safety of the conditioning regimen using cyclophosphamide, total-body irradiation, and alemtuzumab in patients with severe aplastic anemia.
• To assess engraftment and the risk of graft failure in this patient population.
• To assess the risk of acute and chronic graft-vs-host disease.
• To estimate survival at 100 days, 1 year, and 2 years.

OUTLINE:

• Conditioning regimen: Patients receive cyclophosphamide IV on days -6 to -3 (or days -5 to -2); alemtuzumab IV on days -4 to -2 (or days -3 to -1); and undergo 2 fractions of total-body irradiation (TBI) on days -2 to -1 (or days -1 to 0) (for patients with 5/6 HLA matched donor) OR a single fraction of TBI on day -1 (or day 0) (for patients with 6/6 HLA matched donor).
• Allogeneic stem cell transplantation: Patients undergo peripheral blood or bone marrow stem cell infusion on day 0. Donors receive filgrastim (G-CSF) subcutaneously for 4 days before collection and through completion of collection.
• Graft-vs-host disease prophylaxis: Patients receive tacrolimus IV continuously over 24 hours beginning on days -2 then orally every 12 hours to day 60 post-transplant, followed by a taper. Patients also receive methotrexate IV on days 1, 3, 6, and 11*.

NOTE: *Methotrexate on day +11 may be omitted at the discretion of the BMT in-patient attending physician.