Background: Increasing numbers of patients are receiving haplo-identical stem cell transplantation (haplo-SCT) for\ntreatment of acute leukemia with reduced intensity (RIC) or myeloablative (MAC) conditioning regimens. The impact of\nconditioning intensity in haplo-SCT is unknown.\nMethods: We performed a retrospective registry-based study comparing outcomes after T-replete haplo-SCT for\npatients with acute myeloid (AML) or lymphoid leukemia (ALL) after RIC (n = 271) and MAC (n = 425). Regimens were\nclassified as MAC or RIC based on published criteria.\nResults: A combination of post-transplant cyclophosphamide (PT-Cy) with one calcineurin inhibitor and mycophenolate\nmofetil (PT-Cy-based regimen) for graft-versus-host disease (GVHD) prophylaxis was used in 66 (25 %) patients in RIC and\n125 (32 %) in MAC groups. Patients of RIC group were older and had been transplanted more recently and more\nfrequently for AML with active disease at transplant. Percentage of engraftment (90 vs. 92 %; p = 0.58) and day\n100 grade II to IV acute GVHD (24 vs. 29 %, p = 0.23) were not different between RIC and MAC groups. Multivariable\nanalyses, run separately in AML and ALL, showed a trend toward higher relapse incidence with RIC in comparison to\nMAC in AML (hazard ratio (HR) 1.34, p = 0.09), and no difference in both AML and ALL in terms of non-relapse mortality\n(NRM) chronic GVHD and leukemia-free survival. There was no impact of conditioning regimen intensity in overall survival\n(OS) in AML (HR = 0.97, p = 0.79) but a trend for worse OS with RIC in ALL (HR = 1.44, p = 0.10). The main factor impacting\noutcomes was disease status at transplantation (HR � 1.4, p � 0.01). GVHD prophylaxis with PT-Cy-based regimen was\nindependently associated with reduced NRM (HR 0.63, p = 0.02) without impact on relapse incidence (HR 0.99, p = 0.94).\nConclusions: These data suggest that T-replete haplo-SCT with both RIC and MAC, in particular associated with PT-Cy,\nare valid options in first line treatment of high risk AML or ALL.
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