Post-transplantation Cyclophosphamide and Sirolimus after Haploidentical Hematopoietic Stem Cell Transplantation Using a Treosulfan-based Myeloablative.

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Post-transplantation Cyclophosphamide and Sirolimus after Haploidentical Hematopoietic Stem Cell Transplantation Using a Treosulfan-based Myeloablative Conditioning and Peripheral Blood Stem Cells Nicoletta Cieri, Raffaella Greco, Lara Crucitti, Mara Morelli, Fabio Giglio, Giorgia Levati, Andrea Assanelli, Matteo G. Carrabba, Laura Bellio, Raffaella Milani, Francesca Lorentino, Maria Teresa Lupo Stanghellini, Tiago De Freitas, Sarah Marktel, Massimo Bernardi, Consuelo Corti, Luca Vago, Chiara Bonini, Fabio Ciceri, Jacopo Peccatori Biology of Blood and Marrow Transplantation Volume 21, Issue 8, Pages 1506-1514 (August 2015) DOI: 10.1016/j.bbmt.2015.04.025 Copyright © 2015 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 1 Cumulative incidence of (A) neutrophil engraftment and (B) platelet engraftment. Biology of Blood and Marrow Transplantation 2015 21, 1506-1514DOI: (10.1016/j.bbmt.2015.04.025) Copyright © 2015 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 2 Immune reconstitution. Absolute counts of (A) CD3+ T cells, (B) CD8+ T cells, and (C) CD4+ T cells. (D) Flow-cytometric quantification of circulating recent thymic emigrants (expressed as percent of CD31+ cells on CD4+ naïve T cells) before (pre), and after 30 and 180 days from transplantation. (E) Absolute counts of CD56+CD16+CD3− NK cells. (F) Absolute counts CD19+ B cells circulating in peripheral blood of patients at different time points, namely 30, 90, 180, and 365 days after transplantation. Grey shadows denote normal reference values for each subset analyzed. ∗ P < .05; ∗∗∗ P < .001. Biology of Blood and Marrow Transplantation 2015 21, 1506-1514DOI: (10.1016/j.bbmt.2015.04.025) Copyright © 2015 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 3 GVHD. (A) Cumulative incidence of grade II to IV (dashed line) and grade III and IV (full line) aGVHD. (B) Frequency of regulatory T cells (defined as CD25+CD127−FoxP3+ CD4+ T cells) circulating in the peripheral blood of patients at different time-points after transplant and compared with the frequency in both healthy donors' peripheral blood (HDs) and the leukapheresis product (LK) infused. (C) Comparison of Treg frequencies at day 15 in patients subsequently developing or not aGVHD. (D) Cumulative incidence of overall (dashed line) and severe cGVHD (full line) classified according to NIH criteria. * P < .05; *** P < .01; ****P < .001. ns indicates not significant. Biology of Blood and Marrow Transplantation 2015 21, 1506-1514DOI: (10.1016/j.bbmt.2015.04.025) Copyright © 2015 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 4 Cumulative incidence of NRM. Biology of Blood and Marrow Transplantation 2015 21, 1506-1514DOI: (10.1016/j.bbmt.2015.04.025) Copyright © 2015 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 5 Disease relapse. (A) Cumulative incidence of disease relapse in the entire patient cohort. (B) Disease relapse in patients with acute leukemia; the dotted curve represents cumulative incidence of relapses due to genomic loss of the mismatched HLA in leukemic cells (HLA-loss variants), over which are cumulated classical bone marrow relapses (full line). Biology of Blood and Marrow Transplantation 2015 21, 1506-1514DOI: (10.1016/j.bbmt.2015.04.025) Copyright © 2015 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 6 Survival. (A) Kaplan-Meier estimates of disease-free (dashed line) and overall (full line) survival in the entire patient cohort. (B) DFS stratified according to the disease status at transplantation. (C) DFS stratified according to the disease risk index. Biology of Blood and Marrow Transplantation 2015 21, 1506-1514DOI: (10.1016/j.bbmt.2015.04.025) Copyright © 2015 American Society for Blood and Marrow Transplantation Terms and Conditions