The purpose of this study is to evaluate the effect of various clinical variables including HLA-disparity and NK cell-related variables, upon outcomes of allogeneic hematopoietic cell transplantation (HCT) using uniform conditioning regimen including busulfan, fludarabine, and antithymocyte globulin (ATG) in patients with acute myeloid leukemia (AML) in the first complete remission (CR). The donors for allogeneic HCT include HLA-matched siblings, matched unrelated donors, and haploidentical family donors. Therefore, the endpoints of the study are engraftment, secondary graft failure, acute and chronic graft-versus-host disease (GVHD), immune recovery, infections, leukemia recurrence, non-relapse mortality, and relapse-free (RFS) and overall survival (OS) of patients.
Study Type
OBSERVATIONAL
Enrollment
110
perform allogeneic hematopoietic cell transplantation (HCT) using conditioning regimen of busulfan, fludarabine, and antithymocyte globulin
Asan Medical Center
Seoul, South Korea
RECRUITINGleukemia recurrence
reappearance of blast \>5% in bone marrow; reappearance of leukemia blast in extramedullary sites
Time frame: from HCT (day of donor cell infusion) to leukemia recurrence at 2 years after HCT
engraftment
recovery of absolute neutrophil count over \>500/uL
Time frame: from HCT to neutrophil count over >500/uL at 30 days after HCT
GVHD, acute and chronic
occurrence of acute or chronic GVHD after HCT
Time frame: from HCT to the occurrence of GVHD at 2 years after HCT
Non-relapse mortality
occurrence of death without leukemia recurrence
Time frame: from HCT to the occurrence of death without leukemia recurrence at 2 years after HCT
relapse free survival
survival without leukemia recurrence/death
Time frame: from HCT to last the follow-up, leukemia recurrence, or death at 2 years after HCT
overall survival
survival regardless of leukemia recurrence
Time frame: from HCT to the last follow-up or death at 2 years after HCT
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