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Non-myeloablative allogeneic hematopoietic cell transplantation following fludarabine plus 2 Gy TBI or ATG plus 8 Gy TLI: a phase II randomized study from the Belgian Hematological Society.
Baron, Frédéric; Zachée, Pierre; Maertens, Johan; Kerre, Tessa; Ory, Aurélie; Seidel, Laurence; Graux, Carlos; Lewalle, Philippe; Van Gelder, Michel; Theunissen, Koen; Willems, Evelyne; Emonds, Marie-Paule; De Becker, Ann; Beguin, Yves.
Affiliation
  • Baron F; Department of Hematology, University of Liège, and CHU of Liège, Sart-Tilman, 4000, Liège, Belgium. f.baron@ulg.ac.be.
  • Zachée P; ZNA Stuivenberg, Antwerpen, Belgium. Pierre.Zachee@zna.be.
  • Maertens J; AZ Gasthuisberg Leuven, Leuven, Belgium. johan.maertens@uzleuven.be.
  • Kerre T; Ghent University Hospital, Ghent, Belgium. Tessa.Kerre@UGent.be.
  • Ory A; Department of Hematology, University of Liège, and CHU of Liège, Sart-Tilman, 4000, Liège, Belgium. aurelie.ory@chu.ulg.ac.be.
  • Seidel L; Department of Statistics, University of Liège, and CHU of Liège, Liège, Belgium. laurence.seidel@chu.ulg.ac.be.
  • Graux C; Mont-Godine University Hospital (UCL), Yvoir, Belgium. carlos.graux@uclouvain.be.
  • Lewalle P; Jules Bordet Institute (ULB), Bruxelles, Belgium. philippe.lewalle@bordet.be.
  • Van Gelder M; Maastricht University Medical Center, Maastricht, The Netherlands. m.van.gelder@mumc.nl.
  • Theunissen K; Jessa Ziekenhuis, Hasselt, Belgium. Koen.Theunissen@virgajesse.be.
  • Willems E; Department of Hematology, University of Liège, and CHU of Liège, Sart-Tilman, 4000, Liège, Belgium. e.willems@chu.ulg.ac.be.
  • Emonds MP; HLA Red Cross Flanders, Mechelen, Belgium. Marie-Paule.Emonds@rodekruis.be.
  • De Becker A; Universitair Ziekenhuis Brussel (UZ Brussels), Brussels, Belgium. Ann.DeBecker@uzbrussel.be.
  • Beguin Y; Department of Hematology, University of Liège, and CHU of Liège, Sart-Tilman, 4000, Liège, Belgium. yves.beguin@chu.ulg.ac.be.
J Hematol Oncol ; 8: 4, 2015 Feb 06.
Article in En | MEDLINE | ID: mdl-25652604
ABSTRACT

BACKGROUND:

Few studies thus far have compared head-to-head different non-myelooablative conditioning regimens for allogeneic hematopoietic cell transplantation (allo-HCT).

METHODS:

Here, we report the results of a phase II multicenter randomized study comparing non-myeloablative allo-HCT from HLA-identical siblings (n = 54) or from 10/10 HLA-matched unrelated donors (n = 40) with either fludarabine plus 2 Gy total body irradiation (Flu-TBI arm; n = 49) or 8 Gy TLI + anti-thymocyte globulin (TLI-ATG arm; n = 45) conditioning.

RESULTS:

The 180-day cumulative incidences of grade II-IV acute GVHD (primary endpoint) were 12.2% versus 8.9% in Flu-TBI and TLI-ATG patients, respectively (P = 0.5). Two-year cumulative incidences of moderate/severe chronic GVHD were 40.8% versus 17.8% in Flu-TBI and TLI-ATG patients, respectively (P = 0.017). Five Flu-TBI patients and 10 TLI-ATG patients received pre-emptive DLI for low donor chimerism levels, while 1 Flu-TBI patient and 5 TLI-ATG patients (including 2 patients given prior pre-emptive DLIs) received a second HCT for poor graft function, graft rejection, or disease progression. Four-year cumulative incidences of relapse/progression were 22% and 50% in Flu-TBI and TLI-ATG patients, respectively (P = 0.017). Four-year cumulative incidences of nonrelapse mortality were 24% and 13% in Flu-TBI and TLI-ATG patients, respectively (P = 0.5). Finally, 4-year overall (OS) and progression-free survivals (PFS) were 53% and 54%, respectively, in the Flu-TBI arm, versus 54% (P = 0.9) and 37% (P = 0.12), respectively, in the TLI-ATG arm.

CONCLUSIONS:

In comparison to patients included in the Flu-TBI arm, patients included in the TLI-ATG arm had lower incidence of chronic GVHD, higher incidence of relapse and similar OS. TRIAL REGISTRATION The study was registered on ClinicalTrial.gov ( NCT00603954 ) and EUDRACT (2010-024297-19) .
Subject(s)

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Hematopoietic Stem Cell Transplantation / Hematologic Neoplasms / Transplantation Conditioning / Graft vs Host Disease Type of study: Clinical_trials / Incidence_studies / Prognostic_studies Limits: Adult / Aged / Female / Humans / Male / Middle aged Language: En Journal: J Hematol Oncol Journal subject: HEMATOLOGIA / NEOPLASIAS Year: 2015 Document type: Article Affiliation country: Belgium

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Hematopoietic Stem Cell Transplantation / Hematologic Neoplasms / Transplantation Conditioning / Graft vs Host Disease Type of study: Clinical_trials / Incidence_studies / Prognostic_studies Limits: Adult / Aged / Female / Humans / Male / Middle aged Language: En Journal: J Hematol Oncol Journal subject: HEMATOLOGIA / NEOPLASIAS Year: 2015 Document type: Article Affiliation country: Belgium