Fludarabine and 2-Gy TBI is Superior to 2 Gy TBI as Conditioning for HLA-Matched Related Hematopoietic Cell Transplantation: A Phase III Randomized Trial

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Fludarabine and 2-Gy TBI is Superior to 2 Gy TBI as Conditioning for HLA-Matched Related Hematopoietic Cell Transplantation: A Phase III Randomized Trial Brian Kornblit, David G. Maloney, Rainer Storb, Jan Storek, Parameswaran Hari, Vladan Vucinic, Richard T. Maziarz, Thomas R. Chauncey, Michael A. Pulsipher, Benedetto Bruno, Finn B. Petersen, Wolfgang A. Bethge, Kai Hübel, Michelle E. Bouvier, Takahiro Fukuda, Barry E. Storer, Brenda M. Sandmaier Biology of Blood and Marrow Transplantation Volume 19, Issue 9, Pages 1340-1347 (September 2013) DOI: 10.1016/j.bbmt.2013.06.002 Copyright © 2013 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 1 Donor granulocyte and T cell chimerism. Percent donor granulocyte (A) and T cell chimerism (B) in patients conditioned with 2-Gy total body irradiation only (TBI, n = 44) or in combination with 90 mg/m2 fludarabine (FLU/TBI, n = 41). Horizontal lines represent medians, and dots represent the individual data points. P values are 2 tailed. Biology of Blood and Marrow Transplantation 2013 19, 1340-1347DOI: (10.1016/j.bbmt.2013.06.002) Copyright © 2013 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 2 Immune reconstitution. Mean absolute numbers of natural killer (NK) cells (A), CD4+ (B), naïve CD4+ (C), and memory/effector CD4+ (D) cells at days 28 (TBI: n = 16; FLU/TBI: n = 7) and 90 (TBI: n = 8; FLU/TBI: n = 13) after transplantation in patients conditioned with 2-Gy total body irradiation only (TBI) or in combination with 90 mg/m2 fludarabine (FLU/TBI). Bars represent standard error of the mean. P values are 2 tailed. Biology of Blood and Marrow Transplantation 2013 19, 1340-1347DOI: (10.1016/j.bbmt.2013.06.002) Copyright © 2013 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 3 Graft-versus-host disease. Cumulative incidences of grade II to IV acute (A) and chronic (B) GVHD among patients conditioned with 2-Gy total body irradiation only (TBI) or in combination with 90 mg/m2 fludarabine (FLU/TBI). Biology of Blood and Marrow Transplantation 2013 19, 1340-1347DOI: (10.1016/j.bbmt.2013.06.002) Copyright © 2013 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 4 Nonrelapse mortality. Cumulative incidence of nonrelapse mortality among patients conditioned with 2 Gy total body irradiation only (TBI) or in combination with 90 mg/m2 fludarabine (FLU/TBI). Biology of Blood and Marrow Transplantation 2013 19, 1340-1347DOI: (10.1016/j.bbmt.2013.06.002) Copyright © 2013 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 5 Relapse or progression incidence and relapse-related mortality. Cumulative incidences of relapse or progression (A) and relapse-related mortality (B) among patients conditioned with 2-Gy total body irradiation only (TBI) or in combination with 90 mg/m2 fludarabine (FLU/TBI). Biology of Blood and Marrow Transplantation 2013 19, 1340-1347DOI: (10.1016/j.bbmt.2013.06.002) Copyright © 2013 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 6 Progression-free survival and overall survival. Cumulative incidences of progression-free survival (A) and overall survival (B) among patients conditioned with 2-Gy total body irradiation only (TBI) or in combination with 90 mg/m2 fludarabine (FLU/TBI). Biology of Blood and Marrow Transplantation 2013 19, 1340-1347DOI: (10.1016/j.bbmt.2013.06.002) Copyright © 2013 American Society for Blood and Marrow Transplantation Terms and Conditions