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

Results of a multicenter phase I/II trial of TCRαβ and CD19-depleted haploidentical hematopoietic stem cell transplantation for adult and pediatric patients

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  • Media type: E-Article
  • Title: Results of a multicenter phase I/II trial of TCRαβ and CD19-depleted haploidentical hematopoietic stem cell transplantation for adult and pediatric patients
  • Contributor: Bethge, Wolfgang A.; Eyrich, Matthias; Mielke, Stephan; Meisel, Roland; Niederwieser, Dietger; Schlegel, Paul G.; Schulz, Ansgar; Greil, Johann; Bunjes, Donald; Brecht, Arne; Kuball, Jurgen; Schumm, Michael; Vucinic, Vladan; Wiesneth, Markus; Bonig, Halvard; Westinga, Kasper; Biedermann, Stefanie; Holtkamp, Silke; Karitzky, Sandra; Malchow, Michaela; Siewert, Christiane; Handgretinger, Rupert; Lang, Peter
  • imprint: Springer Science and Business Media LLC, 2022
  • Published in: Bone Marrow Transplantation
  • Language: English
  • DOI: 10.1038/s41409-021-01551-z
  • ISSN: 0268-3369; 1476-5365
  • Keywords: Transplantation ; Hematology
  • Origination:
  • Footnote:
  • Description: <jats:title>Abstract</jats:title><jats:p>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 (<jats:italic>n</jats:italic> = 43), myelodysplastic or myeloproliferative syndrome (<jats:italic>n</jats:italic> = 6), multiple myeloma (<jats:italic>n</jats:italic> = 1), solid tumors (<jats:italic>n</jats:italic> = 6), and non-malignant disorders (<jats:italic>n</jats:italic> = 4) were enrolled. TCR αβ/CD19-depleted grafts prepared decentrally at six manufacturing sites contained a median of 12.1 × 10<jats:sup>6</jats:sup> CD34<jats:sup>+</jats:sup> cells/kg and 14.2 × 10<jats:sup>3</jats:sup> TCRαβ<jats:sup>+</jats:sup> 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 2 years were 63% and 50%, respectively. Based on these promising results in a high-risk patient cohort, haploidentical HSCT using TCRαβ/CD19-depleted grafts represents a viable treatment option.</jats:p>
  • Access State: Open Access