Alternative donor transplantation after reduced intensity conditioning: results of parallel phase 2 trials using partially HLA-mismatched related bone marrow or unrelated double umbilical cord blood grafts
Claudio G Brunstein, Ephraim J Fuchs, Shelly L Carter, Chatchada Karanes, Luciano J Costa, Juan Wu, Steven M Devine, John R Wingard, Omar S Aljitawi, Corey S Cutler, Madan H Jagasia, Karen K Ballen, Mary Eapen, Paul V O'Donnell, Blood and Marrow Transplant Clinical Trials Network, Chatchada Karanes, Corey Cutler, Karen Ballen, Marcie Tomblyn, Luciano Jose Megale Costa, Steve Devine, Carlos Bachier, John Wingard, Margarida Silverman, Omar Aljitawi, Claudio G Brunstein, Elizabeth Hexner, Mark B Juckett, Harold M Chung, Peter Westervelt, Tsiporah B Shore, Claudio G Brunstein, Ephraim J Fuchs, Shelly L Carter, Chatchada Karanes, Luciano J Costa, Juan Wu, Steven M Devine, John R Wingard, Omar S Aljitawi, Corey S Cutler, Madan H Jagasia, Karen K Ballen, Mary Eapen, Paul V O'Donnell, Blood and Marrow Transplant Clinical Trials Network, Chatchada Karanes, Corey Cutler, Karen Ballen, Marcie Tomblyn, Luciano Jose Megale Costa, Steve Devine, Carlos Bachier, John Wingard, Margarida Silverman, Omar Aljitawi, Claudio G Brunstein, Elizabeth Hexner, Mark B Juckett, Harold M Chung, Peter Westervelt, Tsiporah B Shore
Abstract
The Blood and Marrow Transplant Clinical Trials Network conducted 2 parallel multicenter phase 2 trials for individuals with leukemia or lymphoma and no suitable related donor. Reduced intensity conditioning (RIC) was used with either unrelated double umbilical cord blood (dUCB) or HLA-haploidentical related donor bone marrow (Haplo-marrow) transplantation. For both trials, the transplantation conditioning regimen incorporated cyclophosphamide, fludarabine, and 200 cGy of total body irradiation. The 1-year probabilities of overall and progression-free survival were 54% and 46%, respectively, after dUCB transplantation (n = 50) and 62% and 48%, respectively, after Haplo-marrow transplantation (n = 50). The day +56 cumulative incidence of neutrophil recovery was 94% after dUCB and 96% after Haplo-marrow transplantation. The 100-day cumulative incidence of grade II-IV acute GVHD was 40% after dUCB and 32% after Haplo-marrow transplantation. The 1-year cumulative incidences of nonrelapse mortality and relapse after dUCB transplantation were 24% and 31%, respectively, with corresponding results of 7% and 45%, respectively, after Haplo-marrow transplantation. These multicenter studies confirm the utility of dUCB and Haplo-marrow as alternative donor sources and set the stage for a multicenter randomized clinical trial to assess the relative efficacy of these 2 strategies. The trials are registered at www.clinicaltrials.gov under NCT00864227 (BMT CTN 0604) and NCT00849147 (BMT CTN 0603).
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Source: PubMed