Baseline characteristics of patients who underwent the transplant in the FIGARO trial grouped based on the posttransplant MRD status
| . | Posttransplant MRD status . | Overall N (%) . | P . | ||
|---|---|---|---|---|---|
| Positive at any time point N (%) . | Negative only N (%) . | Missing throughout∗ N (%) . | |||
| Treatment arm | |||||
| FLAMSA-BU | 10 (34) | 77 (49) | 21 (72) | 108 (50) | .21 |
| Flu/Bu/ATG | 9 (31) | 51 (32) | 3 (10) | 63 (29) | — |
| Flu/melphalan/alemtuzumab | 6 (21) | 21 (13) | 3 (10) | 30 (14) | — |
| Flu/Bu/alemtuzumab | 4 (14) | 9 (6) | 2 (7) | 15 (7) | — |
| Age | |||||
| <=60 y | 19 (66) | 93 (59) | 14 (48) | 126 (58) | .61 |
| >60 y | 10 (34) | 65 (41) | 15 (52) | 90 (42) | — |
| Sex | |||||
| Female | 11 (38) | 68 (43) | 12 (41) | 91 (42) | .97 |
| Male | 18 (62) | 90 (57) | 17 (59) | 125 (58) | — |
| Underlying disease | |||||
| AML | 20 (69) | 101 (64) | 23 (79) | 144 (67) | .44 |
| MDS | 9 (31) | 57 (36) | 6 (21) | 72 (33) | — |
| Patients with cytogenetic risk–AML | |||||
| Adverse risk | 9 (45) | 23 (23) | 12 (52) | 44 (31) | .11 |
| Intermediate risk | 9 (45) | 72 (71) | 11 (48) | 92 (64) | — |
| Favorable risk | 2 (10) | 5 (5) | 7 (5) | — | |
| Unknown | 1 (1) | 1 (1) | — | ||
| Disease status (AML only) | |||||
| CR1/CR2 | 18 (90) | 98 (97) | 22 (96) | 138 (96) | .38 |
| Primary refractory | 2 (10) | 3 (3) | 1 (4) | 6 (4) | — |
| FLT3 | |||||
| Absent | 11 (38) | 62 (39) | 14 (48) | 87 (40) | .76 |
| Present | 7 (24) | 28 (18) | 2 (7) | 37 (17) | — |
| Unknown | 11 (38) | 68 (43) | 13 (45) | 92 (43) | — |
| NPM1 | |||||
| Absent | 15 (52) | 61 (39) | 12 (41) | 88 (41) | .90 |
| Present | 3 (10) | 28 (18) | 4 (14) | 35 (16) | — |
| Unknown | 11 (38) | 69 (44) | 13 (45) | 93 (43) | — |
| IPSS (MDS only) | |||||
| Standard risk (<=2) | 8 (100) | 48 (96) | 4 (100) | 60 (97) | 1 |
| High risk (>2) | 2 (4) | 2 (3) | — | ||
| Donor type | |||||
| Sibling | 8 (28) | 31 (20) | 6 (21) | 45 (21) | .82 |
| Unrelated | 21 (72) | 127 (80) | 23 (79) | 171 (79) | — |
| Stem-cell source | |||||
| Peripheral blood | 29 (100) | 151 (96) | 28 (97) | 208 (96) | .86 |
| BM | 7 (4) | 1 (3) | 8 (4) | — | |
| Pretransplant MRD | |||||
| Positive | 10 (34) | 31 (20) | 2 (7) | 43 (20) | .03 |
| Negative | 12 (41) | 89 (56) | 12 (41) | 113 (52) | — |
| Missing | 7 (24) | 38 (24) | 15 (52) | 60 (28) | — |
| DLI | |||||
| Number receiving DLI (before relapse) | 6 (21) | 22 (14) | 2 (7) | 30 (14) | .32 |
| GVHD | |||||
| Acute GVHD grade 2-4 | 7 (24) | 65 (41) | 10 (34) | 82 (38) | .36 |
| Chronic GVHD | 6 (21) | 58 (37) | 3 (10) | 67 (31) | .02 |
| . | Posttransplant MRD status . | Overall N (%) . | P . | ||
|---|---|---|---|---|---|
| Positive at any time point N (%) . | Negative only N (%) . | Missing throughout∗ N (%) . | |||
| Treatment arm | |||||
| FLAMSA-BU | 10 (34) | 77 (49) | 21 (72) | 108 (50) | .21 |
| Flu/Bu/ATG | 9 (31) | 51 (32) | 3 (10) | 63 (29) | — |
| Flu/melphalan/alemtuzumab | 6 (21) | 21 (13) | 3 (10) | 30 (14) | — |
| Flu/Bu/alemtuzumab | 4 (14) | 9 (6) | 2 (7) | 15 (7) | — |
| Age | |||||
| <=60 y | 19 (66) | 93 (59) | 14 (48) | 126 (58) | .61 |
| >60 y | 10 (34) | 65 (41) | 15 (52) | 90 (42) | — |
| Sex | |||||
| Female | 11 (38) | 68 (43) | 12 (41) | 91 (42) | .97 |
| Male | 18 (62) | 90 (57) | 17 (59) | 125 (58) | — |
| Underlying disease | |||||
| AML | 20 (69) | 101 (64) | 23 (79) | 144 (67) | .44 |
| MDS | 9 (31) | 57 (36) | 6 (21) | 72 (33) | — |
| Patients with cytogenetic risk–AML | |||||
| Adverse risk | 9 (45) | 23 (23) | 12 (52) | 44 (31) | .11 |
| Intermediate risk | 9 (45) | 72 (71) | 11 (48) | 92 (64) | — |
| Favorable risk | 2 (10) | 5 (5) | 7 (5) | — | |
| Unknown | 1 (1) | 1 (1) | — | ||
| Disease status (AML only) | |||||
| CR1/CR2 | 18 (90) | 98 (97) | 22 (96) | 138 (96) | .38 |
| Primary refractory | 2 (10) | 3 (3) | 1 (4) | 6 (4) | — |
| FLT3 | |||||
| Absent | 11 (38) | 62 (39) | 14 (48) | 87 (40) | .76 |
| Present | 7 (24) | 28 (18) | 2 (7) | 37 (17) | — |
| Unknown | 11 (38) | 68 (43) | 13 (45) | 92 (43) | — |
| NPM1 | |||||
| Absent | 15 (52) | 61 (39) | 12 (41) | 88 (41) | .90 |
| Present | 3 (10) | 28 (18) | 4 (14) | 35 (16) | — |
| Unknown | 11 (38) | 69 (44) | 13 (45) | 93 (43) | — |
| IPSS (MDS only) | |||||
| Standard risk (<=2) | 8 (100) | 48 (96) | 4 (100) | 60 (97) | 1 |
| High risk (>2) | 2 (4) | 2 (3) | — | ||
| Donor type | |||||
| Sibling | 8 (28) | 31 (20) | 6 (21) | 45 (21) | .82 |
| Unrelated | 21 (72) | 127 (80) | 23 (79) | 171 (79) | — |
| Stem-cell source | |||||
| Peripheral blood | 29 (100) | 151 (96) | 28 (97) | 208 (96) | .86 |
| BM | 7 (4) | 1 (3) | 8 (4) | — | |
| Pretransplant MRD | |||||
| Positive | 10 (34) | 31 (20) | 2 (7) | 43 (20) | .03 |
| Negative | 12 (41) | 89 (56) | 12 (41) | 113 (52) | — |
| Missing | 7 (24) | 38 (24) | 15 (52) | 60 (28) | — |
| DLI | |||||
| Number receiving DLI (before relapse) | 6 (21) | 22 (14) | 2 (7) | 30 (14) | .32 |
| GVHD | |||||
| Acute GVHD grade 2-4 | 7 (24) | 65 (41) | 10 (34) | 82 (38) | .36 |
| Chronic GVHD | 6 (21) | 58 (37) | 3 (10) | 67 (31) | .02 |
CR1/2, complete remissions 1 or 2; FLAMSA-BU, Flu + cytarabine + amsacrine + Bu; IPSS, international prognostic scoring system.
Missing throughout for MRD status includes the 12 of 216 patients who underwent transplant and died or relapsed up to day +42.