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

Journal of Hematology & Oncology

Yves Beguin²  Ann De Becker⁶  Marie-Paule Emonds^1,10  Evelyne Willems²  Koen Theunissen¹  Michel Van Gelder³  Philippe Lewalle⁸  Carlos Graux⁴  Laurence Seidel⁷  Aurélie Ory²  Tessa Kerre⁵  Johan Maertens⁹  Pierre Zachée^1,11  Frédéric Baron² 

[1] Jessa Ziekenhuis, Hasselt, Belgium;Department of Hematology, University of Liège, and CHU of Liège, Sart-Tilman, Liège, 4000, Belgium;Maastricht University Medical Center, Maastricht, The Netherlands;Mont-Godine University Hospital (UCL), Yvoir, Belgium;Ghent University Hospital, Ghent, Belgium;Universitair Ziekenhuis Brussel (UZ Brussels), Brussels, Belgium;Department of Statistics, University of Liège, and CHU of Liège, Liège, Belgium;Jules Bordet Institute (ULB), Bruxelles, Belgium;AZ Gasthuisberg Leuven, Leuven, Belgium;HLA Red Cross Flanders, Mechelen, Belgium;ZNA Stuivenberg, Antwerpen, Belgium

关键词: Graft-versus-leukemia effects;    GVHD;    ATG;    TLI;    TBI;    Non-myeloablative conditioning;    allo-HCT;   

Others  :  1133471
DOI  :  10.1186/s13045-014-0098-9

 received in 2014-10-15, accepted in 2014-12-20,  发布年份 2015

【 摘 要 】

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 webcite) and EUDRACT (2010-024297-19) webcite.

【 授权许可】

   
2015 Baron et al.; licensee Biomed Central.

【 图 表 】

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