The role of transplantation in infants with acute lymphoblastic leukemia (ALL) is not defined. We analyzed results of 40 infants diagnosed before age 12 months who received a hematopoietic cell transplant (HCT) between July 1982 and February 2003 in first complete remission (CR1; n ؍ 17), CR2/3 (n ؍ 7), or relapse (n ؍ 16). Patients were conditioned with cyclophosphamide with total body irradiation (n ؍ 39) or busulfan (n ؍ 1). Donors were matched related (n ؍ 8), mismatched related (n ؍ 16), or unrelated (n ؍ 16). Graft-versus-host disease (GVHD) prophylaxis was methotrexate or cyclosporine (n ؍ 7) or methotrexate plus cyclosporine (n ؍ 33). Thirty-nine patients engrafted, 20 developed acute GVHD, and 7 developed chronic GVHD. Sixteen patients relapsed and 7 died of other causes. Patients in CR1 had disease-free survival (DFS) of 76% compared with 45% for CR2/CR3 and 8% for relapse (P < .001
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