Phase II Trial of Reduced-Intensity @entity1863 / @entity19859 Conditioning with Allogeneic Hematopoietic Stem Cell Transplantation for @entity1 with @entity3052 , @entity2590 , and XXXX .

@entity1 @entity981 @entity2590 @entity3052 @entity1778 @entity2132 @entity1863 @entity19859 @entity1349
UNASSIGNED: @entity19859 has potent antileukemia activity and its inclusion in reduced-intensity conditioning (RIC) allogeneic hematopoietic stem cell transplantation (HSCT) for acute @entity1778 could potentially improve outcomes. We conducted a phase II study of @entity1863 (.8 mg/kg i.v. twice daily on days  -5,  -4,  -3, and  -2) with @entity19859 (40 mg/m(2) i.v. daily on days  -5,  -4,  -3, and  -2) conditioning before allogeneic 8/8 HLA-matched related or unrelated HSCT. The primary endpoint was donor neutrophil engraftment by day  +40. Secondary endpoints included nonrelapse mortality (NRM), @entity2132 ( @entity2132 ), progression-free survival (PFS), and @entity1349 ( @entity1349 ). Thirty-four @entity1 ( @entity3052 [ @entity3052 ], n  = 25; @entity2590 , n  = 5; and @entity981 , n  = 4) were enrolled. Day 40+ engraftment with donor chimerism was achieved in 33 of 34 @entity1 with 1 @entity1 dying before count recovery. Day 100 and 1-year NRM were 5.9% (95% confidence interval [CI], 1.0 to 17.4) and 24% (95% CI, 11 to 39), respectively. The 2-year relapse rate was 26% (95% CI, 13 to 42). Cumulative incidences of acute and chronic @entity2132 were 21% and 44%, respectively. The 2-year PFS was 50% (95% CI, 32 to 65) and @entity1349 was 56% (95% CI, 38 to 71). For @entity1 with @entity3052 in first complete remission, 2-year PFS and @entity1349 were both 82% (95% CI, 55 to 94). RIC with @entity1863 and @entity19859 leads to successful engraftment with acceptable rates of NRM and @entity2132 .
