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
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
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DOI：
10.1182/blood-2011-03-344853
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发表时间：
2011-07-14
期刊：
影响因子：
20.3
通讯作者：
O'Donnell, Paul V.
中科院分区：
文献类型：
--
作者：
Brunstein, Claudio G.;Fuchs, Ephraim J.;O'Donnell, Paul V.
血液和骨髓移植临床试验网络对白血病或淋巴瘤患者进行了2个平行的多中心2期试验，没有合适的相关供体。降低强度调节（RIC）用于无亲缘关系的双脐带血（dUCB）或hla -单倍体相同的相关供体骨髓（haploo -marrow）移植。在两项试验中，移植调理方案均采用环磷酰胺、氟达拉滨和200cgy的全身照射。dUCB移植（n = 50）后的1年总生存率和无进展生存率分别为54%和46%，单倍骨髓移植（n = 50）后的1年总生存率和无进展生存率分别为62%和48%。dUCB术后+56天累积中性粒细胞恢复率为94%，单倍骨髓移植术后为96%。dUCB后100天II-IV级急性GVHD累积发生率为40%，单倍骨髓移植后为32%。dUCB移植后1年累计非复发死亡率和复发率分别为24%和31%，单倍骨髓移植后1年累计非复发死亡率和复发率分别为7%和45%。这些多中心研究证实了dUCB和单倍骨髓作为替代供体来源的效用，并为多中心随机临床试验奠定了基础，以评估这两种策略的相对疗效。这些试验在www.clinicaltrials.gov上注册，编号为NCT00864227 （BMT CTN 0604）和NCT00849147 （BMT CTN 0603）。(Blood.2011; 118 (2): 282 - 288)
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 non-relapse 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). (Blood.2011;118(2):282-288)