Reduced-Intensity Conditioning with Busulfan, Fludarabine, and Antithymocyte Globulin for Hematopoietic Cell Transplantation from Unrelated or Haploidentical Family Donors in Patients with Acute Myeloid Leukemia in Remission.

Lee, Kyoo-Hyung; Lee, Je-Hwan; Lee, Jung-Hee; Kim, Dae-Young; Park, Han-Seung; Choi, Eun-Ji; Ko, Sun-Hye; Seol, Miee; Lee, Young-Shin; Kang, Young-A; Jeon, Mijin; Baek, Seunghyun; Kang, You-Lee; Kim, Sung-Han; Yun, Sung-Cheol; Kim, Hawk; Jo, Jae-Cheol; Choi, Yunsuk; Joo, Young-Don; Lim, Sung-Nam
Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation
2017May ; 17 ( 6 ) :.
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Lee, Kyoo-Hyung -
Lee, Je-Hwan -
Lee, Jung-Hee -
Kim, Dae-Young -
Park, Han-Seung -
Choi, Eun-Ji -
Ko, Sun-Hye -
Seol, Miee -
Lee, Young-Shin -
Kang, Young-A -
Jeon, Mijin -
Baek, Seunghyun -
Kang, You-Lee -
Kim, Sung-Han -
Yun, Sung-Cheol -
Kim, Hawk -
Jo, Jae-Cheol -
Choi, Yunsuk -
Joo, Young-Don -
Lim, Sung-Nam -
ABSTRACT
To investigate the role of antithymocyte globulin (ATG)-containing reduced-intensity conditioning (RIC) in hematopoietic cell transplantation (HCT) from unrelated (UD) or haploidentical family donors (HFD), we conducted a phase 2 trial of 237 patients (age range, 16 to 69 years) with acute myeloid leukemia (AML) in remission. Patients undergoing UD-HCT (n?=?93) or HFD-HCT (n?=?59) received RIC comprising busulfan, fludarabine, and ATG, 9?mg/kg, whereas those undergoing HCT from matched sibling donors (MSD, n?=?85) received myeloablative busulfan and cyclophosphamide conditioning or aforementioned RIC with ATG, 4.5?mg/kg. For graft-versus-host disease (GVHD) prophylaxis, cyclosporine and methotrexate were administered. The median follow-up period was 44.7 months after HCT for 161 survivors. For UD-HCT versus HFD-HCT, there were no significant differences in leukemia recurrence, nonrelapse mortality, relapse-free survival, grades 2 to 4 acute GVHD, and moderate-to-severe chronic GVHD. Furthermore, when the outcomes of UD-HCT and HFD-HCT were combined and compared with those of MSD-HCT, there were no significant differences in leukemia recurrence (3-year cumulative incidence, 30% versus 29%), nonrelapse mortality (3-year cumulative incidence, 7% versus 8%), relapse-free survival (3-year estimate, 63% versus 63%), and grades 2 to 4 acute GVHD (120-day cumulative incidence, 16% versus 13%). Moderate-to-severe chronic GVHD, however, occurred less frequently in UD/HFD-HCT (2-year cumulative incidence, 22% versus 40%; P?=?.006). The addition of ATG to conditioning regimen was a significant predictor for less chronic GVHD (subdistribution hazard ratio, .59). In AML in remission, UD/HFD-HCT after ATG-containing RIC achieved leukemia control equivalent to that of MSD-HCT. Despite HLA disparity in UD/HFD-HCT, chronic GVHD occurred less frequently after ATG-containing RIC, suggesting a strong GVHD-modulating effect of ATG. CI - Copyright ??2017 The American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.
Acute myeloid leukemia; Allogeneic hematopoietic cell transplantation; Antithymocyte globulin; Busulfan; Fludarabine; HLA-haploidentical family donor; HLA-matched sibling donor; HLA-matched unrelated donor
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In AML in remission, UD/HFD-HCT after ATG-containing RIC achieved leukemia control equivalent to that of MSD-HCT. Despite HLA disparity in UD/HFD-HCT, chronic GVHD occurred less frequently after ATG-containing RIC, suggesting a strong GVHD-modulating effect of ATG.
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DOI
10.1016/j.bbmt.2017.05.025.
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ICD 03
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