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Single-agent GvHD prophylaxis with tacrolimus after post-transplant high-dose cyclophosphamide is a valid option for haploidentical transplantation in adults with hematological malignancies

Abstract

Eighty-one patients with high-risk hematological malignancies received unmanipulated haploidentical stem cell transplants (haploSCT) using the same protocol at four Spanish institutions. The conditioning regimen was thiotepa, busulfan and fludarabine; following bone marrow or peripheral blood infusion. GvHD prophylaxis with high-dose cyclophosphamide on days +3 and +4, and IV tacrolimus from day +5 was administered. 62% were in complete remission, 17% had received previous allogeneic SCT and 44% had a high-very high refined disease risk index. One patient had primary graft failure and three more died before +21. The median days to neutrophil and platelet recoveries were +18 and +23, respectively, and 93% achieved a full donor chimerism on day +30. At 1 year, cumulative incidences (CumInc) of non-relapse mortality and relapse were 27 and 19%. One-year overall survival and PFS were 61 and 51%. CumInc of grade II−IV and III−IV were 23 and 14%. At 30 months, CumInc of limited and extensive GvHD were 20 and 22%. In conclusion, patients with hematological malignancies who receive an unmanipulated haploSCT with post-transplant cyclophosphamide may benefit from less intense pharmacological prophylaxis for GvHD prophylaxis. Whether this approach potentiates the graft-versus-tumor effect and decreases relapses requires further investigation.

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Acknowledgements

This work was supported in part by grants AGAUR 2014SGR-1281, ISCIII PI14/00450, PIE15/00028, RD12/0036/0071, a grant from Cellex Research Foundation, Barcelona, Spain, a grant from Jose Carreras Leukemia Research Institute and a grant from ‘Obra social La Caixa’.

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Correspondence to A Esquirol.

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Esquirol, A., Pascual, M., Ortiz, M. et al. Single-agent GvHD prophylaxis with tacrolimus after post-transplant high-dose cyclophosphamide is a valid option for haploidentical transplantation in adults with hematological malignancies. Bone Marrow Transplant 52, 1273–1279 (2017). https://doi.org/10.1038/bmt.2017.111

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