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Results of a multicenter phase I/II trial of TCRαβ and CD19-depleted haploidentical hematopoietic stem cell transplantation for adult and pediatric patients by Wolfgang A. Bethge; Matthias Eyrich; Stephan Mielke; Roland Meisel; Dietger Niederwieser; Paul G. Schlegel; Ansgar Schulz; Johann Greil; Donald Bunjes; Arne Brecht; Jurgen Kuball; Michael Schumm; Vladan Vucinic; Markus Wiesneth; Halvard Bonig; Kasper Westinga; Stefanie Biedermann; Silke Holtkamp; Sandra Karitzky; Michaela Malchow; Christiane Siewert; Rupert Handgretinger; Peter Lang is a Medicine article available to read on EtoBox.

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## Abstract Hematopoietic stem cell transplantation (HSCT) from haploidentical donors is a viable option for patients lacking HLA-matched donors. Here we report the results of a prospective multicenter phase I/II trial of transplantation of TCRαβ and CD19-depleted peripheral blood stem cells from haploidentical family donors after a reduced-intensity conditioning with fludarabine, thiotepa, and melphalan. Thirty pediatric and 30 adult patients with acute leukemia (n = 43), myelodysplastic or myeloproliferative syndrome (n = 6), multiple myeloma (n = 1), solid tumors (n = 6), and non-malignant disorders (n = 4) were enrolled. TCR αβ/CD19-depleted grafts prepared decentrally at six manufacturing sites contained a median of 12.1 × 10^6^ CD34^+^ cells/kg and 14.2 × 10^3^ TCRαβ^+^ T-cells/kg. None of the patients developed grade lll/IV acute graft-versus-host disease (GVHD) and only six patients (10%) had grade II acute GVHD. With a median follow-up of 733 days 36/60 patients are alive. The cumulative incidence of non-relapse mortality at day 100, 1 and 2 years after HSCT was 5%, 15%, and 17% for all patients, respectively. Estimated probabilities of overall and disease-free survival at

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Author

Wolfgang A. Bethge; Matthias Eyrich; Stephan Mielke; Roland Meisel; Dietger Niederwieser; Paul G. Schlegel; Ansgar Schulz; Johann Greil; Donald Bunjes; Arne Brecht; Jurgen Kuball; Michael Schumm; Vladan Vucinic; Markus Wiesneth; Halvard Bonig; Kasper Westinga; Stefanie Biedermann; Silke Holtkamp; Sandra Karitzky; Michaela Malchow; Christiane Siewert; Rupert Handgretinger; Peter Lang

Publisher

Springer Science and Business Media LLC

Published

2021

Language

EN

Field

Medicine (Health Sciences)