Patient characteristics
| Factors . | All patients . | With gilteritinib . | Without gilteritinib . | P value . |
|---|---|---|---|---|
| n = 25 . | n = 14 . | n = 11 . | ||
| Age, y (median range]) | 52 (25-72) | 50 (32-72) | 53 (25-70) | .94 |
| Transplantation years before 2018, n (%) | 6 (24%) | 2 (14.3) | 4 (36.4) | .35 |
| WBC count at SCT, /μL (median range]) | 110 (0-6420) | 245 (0-2960) | 80 (0-6420) | .48 |
| Hb at SCT, g/dL (median [range]) | 8.6 (6.8-13.2) | 8.6 (6.8-13.2) | 8.7 (7.1-12.2) | .93 |
| Plt at SCT, 104/μL (median [range]) | 4.2 (1.5-33.2) | 5.0 (1.5-11.5) | 3.9 (2.2-33.2) | .96 |
| LDH at SCT, U/L (median [range]) | 244 (98-512) | 285 (124-512) | 190 (98-322) | .007 |
| sCre at SCT, mg/dL (median [range]) | 0.53 (0.32-0.85) | 0.56 (0.32-0.85) | 0.52 (0.4-0.77) | .41 |
| T-Bil at SCT, mg/L (median [range]) | 0.69 (0.29-2.3) | 0.76 (0.4-1.17) | 0.58 (0.29-2.3) | .17 |
| Conventional karyotype, n (%) | ||||
| Normal karyotype | 17 (68.0) | 10 (71.4) | 7 (63.6) | 1 |
| FLT3-ITD/TKD, n (%) | ||||
| ITD | 20 (80.0) | 11 (78.6) | 9 (81.8) | 1 |
| TKD | 3 (12.0) | 2 (14.3) | 1 (9.1) | |
| Both | 2 (8.0) | 1 (7.1) | 1 (9.1) | |
| Previous administration of FLT3-inhibitor before SCT, n (%) | ||||
| YES | 19 (76.0) | 14 (100) | 5 (45.5) | .003 |
| AML status at SCT, n (%) | ||||
| CR, WT1 neg | 6 (24.0) | 3 (21.4) | 3 (27.3) | .44 |
| CR, WT1 pos | 12 (48.0) | 9 (64.3) | 4 (36.4) | |
| non-CR | 6 (24.0) | 2 (14.3) | 4 (36.4) | |
| Number of SCT, n (%) | ||||
| First SCT | 19 (76.0) | 11 (78.6) | 8 (72.7) | .79 |
| Second SCT | 5 (20.0) | 2 (14.3) | 3 (27.3) | |
| Third SCT | 1 (4.0) | 1 (7.1) | 0 (0.0) | |
| Conditioning intensity, n (%) | ||||
| MAC | 17 (68.0) | 9 (64.3) | 8 (72.7) | 1 |
| HCT-CI (%)∗ | ||||
| 0 | 4 (20.0) | 2 (25.0) | 2 (16.7) | .88 |
| 1 | 11 (55.0) | 5 (62.5) | 6 (50.0) | |
| 2 | 2 (10.0) | 1 (12.5) | 1 (8.3) | |
| 3 ≤ | 3 (15.0) | 0 ( 0.0) | 3 (27.3) | |
| Donor selection, n (%) | ||||
| 8/8 matched related | 5 (20.0) | 3 (21.4) | 2 (18.2) | .85 |
| 8/8 matched unrelated | 3 (12.0) | 1 (7.1) | 2 (18.2) | |
| 7/8 mismatched unrelated | 1 (4.0) | 1 (7.1) | 0 (0.0) | |
| ≤6/8 haplo-identical | 7 (28.0) | 3 (21.4) | 4 (36.4) | |
| Cord blood | 9 (36.0) | 6 (42.9) | 3 (27.3) | |
| Post-SCT status at day 28-45, n (%) | ||||
| CR, MRD neg | 8 (32.0) | 3 (21.4) | 5 (45.5) | .14 |
| CR, MRD pos | 16 (64.0) | 11 (78.6) | 5 (45.5) | |
| CR, not MRD evaluated | 1 (4.0) | 0 (0.0) | 1 (9.1) |
| Factors . | All patients . | With gilteritinib . | Without gilteritinib . | P value . |
|---|---|---|---|---|
| n = 25 . | n = 14 . | n = 11 . | ||
| Age, y (median range]) | 52 (25-72) | 50 (32-72) | 53 (25-70) | .94 |
| Transplantation years before 2018, n (%) | 6 (24%) | 2 (14.3) | 4 (36.4) | .35 |
| WBC count at SCT, /μL (median range]) | 110 (0-6420) | 245 (0-2960) | 80 (0-6420) | .48 |
| Hb at SCT, g/dL (median [range]) | 8.6 (6.8-13.2) | 8.6 (6.8-13.2) | 8.7 (7.1-12.2) | .93 |
| Plt at SCT, 104/μL (median [range]) | 4.2 (1.5-33.2) | 5.0 (1.5-11.5) | 3.9 (2.2-33.2) | .96 |
| LDH at SCT, U/L (median [range]) | 244 (98-512) | 285 (124-512) | 190 (98-322) | .007 |
| sCre at SCT, mg/dL (median [range]) | 0.53 (0.32-0.85) | 0.56 (0.32-0.85) | 0.52 (0.4-0.77) | .41 |
| T-Bil at SCT, mg/L (median [range]) | 0.69 (0.29-2.3) | 0.76 (0.4-1.17) | 0.58 (0.29-2.3) | .17 |
| Conventional karyotype, n (%) | ||||
| Normal karyotype | 17 (68.0) | 10 (71.4) | 7 (63.6) | 1 |
| FLT3-ITD/TKD, n (%) | ||||
| ITD | 20 (80.0) | 11 (78.6) | 9 (81.8) | 1 |
| TKD | 3 (12.0) | 2 (14.3) | 1 (9.1) | |
| Both | 2 (8.0) | 1 (7.1) | 1 (9.1) | |
| Previous administration of FLT3-inhibitor before SCT, n (%) | ||||
| YES | 19 (76.0) | 14 (100) | 5 (45.5) | .003 |
| AML status at SCT, n (%) | ||||
| CR, WT1 neg | 6 (24.0) | 3 (21.4) | 3 (27.3) | .44 |
| CR, WT1 pos | 12 (48.0) | 9 (64.3) | 4 (36.4) | |
| non-CR | 6 (24.0) | 2 (14.3) | 4 (36.4) | |
| Number of SCT, n (%) | ||||
| First SCT | 19 (76.0) | 11 (78.6) | 8 (72.7) | .79 |
| Second SCT | 5 (20.0) | 2 (14.3) | 3 (27.3) | |
| Third SCT | 1 (4.0) | 1 (7.1) | 0 (0.0) | |
| Conditioning intensity, n (%) | ||||
| MAC | 17 (68.0) | 9 (64.3) | 8 (72.7) | 1 |
| HCT-CI (%)∗ | ||||
| 0 | 4 (20.0) | 2 (25.0) | 2 (16.7) | .88 |
| 1 | 11 (55.0) | 5 (62.5) | 6 (50.0) | |
| 2 | 2 (10.0) | 1 (12.5) | 1 (8.3) | |
| 3 ≤ | 3 (15.0) | 0 ( 0.0) | 3 (27.3) | |
| Donor selection, n (%) | ||||
| 8/8 matched related | 5 (20.0) | 3 (21.4) | 2 (18.2) | .85 |
| 8/8 matched unrelated | 3 (12.0) | 1 (7.1) | 2 (18.2) | |
| 7/8 mismatched unrelated | 1 (4.0) | 1 (7.1) | 0 (0.0) | |
| ≤6/8 haplo-identical | 7 (28.0) | 3 (21.4) | 4 (36.4) | |
| Cord blood | 9 (36.0) | 6 (42.9) | 3 (27.3) | |
| Post-SCT status at day 28-45, n (%) | ||||
| CR, MRD neg | 8 (32.0) | 3 (21.4) | 5 (45.5) | .14 |
| CR, MRD pos | 16 (64.0) | 11 (78.6) | 5 (45.5) | |
| CR, not MRD evaluated | 1 (4.0) | 0 (0.0) | 1 (9.1) |
| Factors at gilteritinib administration post-SCT . | ||||
|---|---|---|---|---|
| WBC count/μL (median [range]) | 3960 (1300-6830) | |||
| Hb, g/dL (median [range]) | 9.1 (7.5-11.3) | |||
| Plt, 104/μL (median [range]) | 5.8 (1.4-21.0) | |||
| Antifungal drug at initiation of gilteritinib | ||||
| FLCZ | 7 (50.0) | |||
| VRCZ | 2 (14.3) | |||
| PSCZ | 2 (14.3) | |||
| L-Amb | 1 (7.1) | |||
| MCFG | 2 (14.3) | |||
| Days from SCT to gilteritinib administration (median [range]) | 36 (21-110) | |||
| Gilteritinib initial dose, mg/day, n (%) | ||||
| 40 | 8 (57.1) | |||
| 80 | 3 (21.4) | |||
| 120 | 3 (21.4) | |||
| Gilteritinib maximum dose, mg/d (median [range]) | 120 (40-120) | |||
| Factors at gilteritinib administration post-SCT . | ||||
|---|---|---|---|---|
| WBC count/μL (median [range]) | 3960 (1300-6830) | |||
| Hb, g/dL (median [range]) | 9.1 (7.5-11.3) | |||
| Plt, 104/μL (median [range]) | 5.8 (1.4-21.0) | |||
| Antifungal drug at initiation of gilteritinib | ||||
| FLCZ | 7 (50.0) | |||
| VRCZ | 2 (14.3) | |||
| PSCZ | 2 (14.3) | |||
| L-Amb | 1 (7.1) | |||
| MCFG | 2 (14.3) | |||
| Days from SCT to gilteritinib administration (median [range]) | 36 (21-110) | |||
| Gilteritinib initial dose, mg/day, n (%) | ||||
| 40 | 8 (57.1) | |||
| 80 | 3 (21.4) | |||
| 120 | 3 (21.4) | |||
| Gilteritinib maximum dose, mg/d (median [range]) | 120 (40-120) | |||
AML, acute myeloid leukemia; FLCZ, fluconazole; FLT3-ITD/TKD, fms-like tyrosine kinase 3-internal tandem duplication/tyrosine kinase domain; Hb, hemoglobin; HCT-CI, hematopoietic cell transplant-comorbidity index; MAC, myeloablative conditioning regimen; MCFG, micafungin; L-Amb, liposomal amphotericin B; LDH, lactate dehydrogenase; Plt, platelet; PSCZ, posaconazole; sCre, serum creatinine; SCT, stem-cell transplantation; T-Bil, total bilirubin; VRCZ, voriconazole; WBC, white blood cell.
n = 20