Haploidentical allogeneic hematopoietic cell transplantation in adults using CD3/CD19 depletion and reduced intensity conditioning
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Haploidentical allogeneic hematopoietic cell transplantation in adults using CD3/CD19 depletion and reduced intensity conditioning : a phase II study. / Federmann, Birgit; Bornhauser, Martin; Meisner, Christoph; Kordelas, Lambros; Beelen, Dietrich W; Stuhler, Gernot; Stelljes, Matthias; Schwerdtfeger, Rainer; Christopeit, Maximilian; Behre, Gerhard; Faul, Christoph; Vogel, Wichard; Schumm, Michael; Handgretinger, Rupert; Kanz, Lothar; Bethge, Wolfgang A.
in: HAEMATOLOGICA, Jahrgang 97, Nr. 10, 10.2012, S. 1523-31.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Haploidentical allogeneic hematopoietic cell transplantation in adults using CD3/CD19 depletion and reduced intensity conditioning
T2 - a phase II study
AU - Federmann, Birgit
AU - Bornhauser, Martin
AU - Meisner, Christoph
AU - Kordelas, Lambros
AU - Beelen, Dietrich W
AU - Stuhler, Gernot
AU - Stelljes, Matthias
AU - Schwerdtfeger, Rainer
AU - Christopeit, Maximilian
AU - Behre, Gerhard
AU - Faul, Christoph
AU - Vogel, Wichard
AU - Schumm, Michael
AU - Handgretinger, Rupert
AU - Kanz, Lothar
AU - Bethge, Wolfgang A
PY - 2012/10
Y1 - 2012/10
N2 - 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 × 10(6) (range 3.2-22) CD34(+) cells/kg, 4.2 × 10(4) (range 0.6-44) CD3(+) T cells/kg and 2.7 × 10(7) (range 0.00-37.3) CD56(+) cells/kg.RESULTS: Engraftment was rapid with a median of 12 days to granulocytes more than 0.5 × 10(9)/L (range 9-50 days) and 11 days to platelets more than 20 × 10(9) (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).
AB - 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 × 10(6) (range 3.2-22) CD34(+) cells/kg, 4.2 × 10(4) (range 0.6-44) CD3(+) T cells/kg and 2.7 × 10(7) (range 0.00-37.3) CD56(+) cells/kg.RESULTS: Engraftment was rapid with a median of 12 days to granulocytes more than 0.5 × 10(9)/L (range 9-50 days) and 11 days to platelets more than 20 × 10(9) (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).
KW - Adult
KW - Aged
KW - Antigens, CD19
KW - Antigens, CD34
KW - CD3 Complex
KW - Chimerism
KW - Female
KW - Graft Survival
KW - Graft vs Host Disease
KW - Haplotypes
KW - Hematologic Diseases
KW - Hematopoietic Stem Cell Transplantation
KW - Hematopoietic Stem Cells
KW - Humans
KW - Leukemia
KW - Lymphocyte Depletion
KW - Lymphoma, Non-Hodgkin
KW - Major Histocompatibility Complex
KW - Male
KW - Middle Aged
KW - Multiple Myeloma
KW - Myelodysplastic Syndromes
KW - Receptors, KIR
KW - Risk Factors
KW - Tissue Donors
KW - Transplantation Conditioning
KW - Transplantation, Homologous
KW - Treatment Outcome
KW - Young Adult
KW - Clinical Trial, Phase II
KW - Journal Article
KW - Multicenter Study
KW - Research Support, Non-U.S. Gov't
U2 - 10.3324/haematol.2011.059378
DO - 10.3324/haematol.2011.059378
M3 - SCORING: Journal article
C2 - 22491731
VL - 97
SP - 1523
EP - 1531
JO - HAEMATOLOGICA
JF - HAEMATOLOGICA
SN - 0390-6078
IS - 10
ER -