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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
- Bethge, WA (author)
- Eyrich, M (author)
-
- Mielke, S (author)
- Karolinska Institutet
- show more...
- Meisel, R (author)
- Niederwieser, D (author)
- Schlegel, PG (author)
- Schulz, A (author)
- Greil, J (author)
- Bunjes, D (author)
- Brecht, A (author)
- Kuball, J (author)
- Schumm, M (author)
- Vucinic, V (author)
- Wiesneth, M (author)
- Bonig, H (author)
- Westinga, K (author)
- Biedermann, S (author)
- Holtkamp, S (author)
- Karitzky, S (author)
- Malchow, M (author)
- Siewert, C (author)
- Handgretinger, R (author)
- Lang, P (author)
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- (creator_code:org_t)
- 2021-12-24
- 2022
- English.
- In: Bone marrow transplantation. - : Springer Science and Business Media LLC. - 1476-5365 .- 0268-3369. ; 57:3, s. 423-430
- Journal article (peer-reviewed)
Abstract
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- 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 × 106 CD34+ cells/kg and 14.2 × 103 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 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.
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- Bethge, WA
- Eyrich, M
- Mielke, S
- Meisel, R
- Niederwieser, D
- Schlegel, PG
- show more...
- Schulz, A
- Greil, J
- Bunjes, D
- Brecht, A
- Kuball, J
- Schumm, M
- Vucinic, V
- Wiesneth, M
- Bonig, H
- Westinga, K
- Biedermann, S
- Holtkamp, S
- Karitzky, S
- Malchow, M
- Siewert, C
- Handgretinger, R
- Lang, P
- show less...
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- Karolinska Institutet
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