Post-Transplantation Relapse
death
Of the 64 gilteritinib arm patients who underwent HSCT, 52 (81%) achieved CRc either before or after transplantation; 36 of these 52 (69%) patients resumed gilteritinib after HSCT. Eight of these 36 patients relapsed; the median time to relapse was 6.6 months (range, 4.8 to 15.2 months) from the date of HSCT. The 17 patients who did not resume gilteritinib therapy after transplantation were not required to undergo regular bone marrow evaluation per protocol and underwent follow-up for OS. Seven of these 17 patients had achieved pretransplantation CRc (CR, n = 1; CRi, n = 5; CRp, n = 1); 2 of these 7 patients had relapsed before HSCT.The cumulative incidence of relapse in gilteritinib arm patients from the time of achieving pretransplantation CR or CRc is shown in Among the patients who resumed gilteritinib after HSCT and had achieved a pretransplantation CR (n = 4) or CRc (n = 20), the cumulative relapse rates were 0% and 19%, respectively, at both 12 and 24 months. Among 53 gilteritinib arm patients without relapse for 60 days post-HSCT, the pretransplantation rate of CRc was higher in patients who resumed gilteritinib after HSCT compared with those who did not resume gilteritinib (72% versus 41%) (Of the 40 patients who resumed gilteritinib after HSCT, 29 had discontinued treatment at the time of data cutoff and 11 continued to receive gilteritinib. The most common reasons for discontinuation were death (24%; n = 7 of 29), relapse (21%; n = 6 of 29), AEs (21%; n = 6 of 29), and physician decision (17%; n = 5 of 29).