Haploidentical allogeneic hematopoietic cell transplantation in adults using CD3/CD19 depletion and reduced intensity conditioning: a phase II study

Autor: Birgit Federmann, Martin Bornhauser, Christoph Meisner, Lambros Kordelas, Dietrich W. Beelen, Gernot Stuhler, Matthias Stelljes, Rainer Schwerdtfeger, Maximilian Christopeit, Gerhard Behre, Christoph Faul, Wichard Vogel, Michael Schumm, Rupert Handgretinger, Lothar Kanz, Wolfgang A. Bethge
Jazyk: angličtina
Rok vydání: 2012
Předmět:
Zdroj: Haematologica, Vol 97, Iss 10 (2012)
Druh dokumentu: article
ISSN: 0390-6078
1592-8721
DOI: 10.3324/haematol.2011.059378
Popis: Background We report a prospective multicenter phase II study of haploidentical hematopoietic stem cell transplantation using CD3/CD19-depleted grafts after reduced intensity conditioning with fludarabine, thiotepa, melphalan and OKT-3.Design and Methods Sixty-one adults with a median age of 46 years (range 19-65 years) have been enrolled. Diagnoses were acute myeloid leukemia (n=38), acute lymphoblastic leukemia (n=8), non-Hodgkin's lymphoma (n=6), myeloma (n=4), chronic myeloid leukemia (n=3), chronic lymphatic leukemia (n=1) and myelodysplastic syndrome (n=1). Patients were considered high risk because of refractory disease (n=18), cytogenetics (n=6), complete remission (≥2) (n=9), chemosensitive relapse in partial remission (n=4) or relapse after prior hematopoietic stem cell transplantation (n=15 allogeneic, n=8 autologous, n=1 both). At haploidentical hematopoietic stem cell transplantation, 30 patients were in complete remission and 31 in partial remission. Grafts contained a median of 7.0×106 (range 3.2-22) CD34+ cells/kg, 4.2×104 (range 0.6-44) CD3+ T cells/kg and 2.7×107 (range 0.00-37.3) CD56+ cells/kg.Results Engraftment was rapid with a median of 12 days to granulocytes more than 0.5×109/L (range 9-50 days) and 11 days to platelets more than 20×109 (range 7-38 days). Incidence of grade IIIV acute graft-versus-host-disease and chronic graft-versus-host-disease was 46% and 18%, respectively. Non-relapse mortality on Day 100 was 23% and 42% at two years. Cumulative incidence of relapse/progression at two years was 31%. Kaplan-Meier estimated 1-year and 2-year overall survival with median follow up of 869 days (range 181-1932) is 41% and 28%, respectively.Conclusions This regimen allows successful haploidentical hematopoietic stem cell transplantation with reduced intensity conditioning in high-risk patients lacking a suitable donor. (clinicaltrials.gov identifier:NCT00202917).
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