Table 2.
Cohort | Subject number | Sex/age | WHO diagnosis | Donor | GVHD gradea | Cycle (mg/m2/day for 5 days) | ||||
---|---|---|---|---|---|---|---|---|---|---|
Acute | Chronic | 1 | 2 | 3 | 4 | |||||
1 | 1 | F/19 | RAEB-2 | MSD | 0 | 0 | 5b,c | 1.5 | 1.5 | 1.5 |
2 | M/36 | AML | MSD | 0 | 0 | 5b | 6 | 5.5 | 6 | |
3 | M/60 | RAEB-2 | MUD | 1 | 0 | 5 | – | – | – | |
4 | M/48 | AML | MSD | 0 | 0 | 5b,c | 1.5 | 2.5 | 3 | |
2 | 5 | M/64 | RAEB-2 | PMUD | 1 | 0 | 4b | 4 | 5.5 | 7 |
6 | F/43 | RAEB-2 | MSD | 0 | 0 | 4b | 7 | 8 | 12 | |
7 | M/64 | AML | MSD | 0 | 0 | 4b | 6 | 5.5 | 5.5 | |
3 | 8 | F/51 | RAEB-2 | MUD | 1 | 0 | 5b | 7.5b,c | 7.5c | 7 |
9 | F/59 | RAEB-1 | MUD | 2 | 0 | 5b,c | 3.5 | 4 | 4.5 | |
10 | F/36 | RAEB-2 | MUD | 1 | 0 | 5b | 6b | 8.5 | 9 | |
4 | 11 | M/64 | RAEB-2 | MSD | 2 | 0 | 5.5b | 2b | – | – |
12 | M/60 | RAEB-2 | MSD | 0 | Mild | 5.5b,c | 4.5b | 7 | 8 | |
13 | M/41 | RAEB-2 | MSD | 0 | 0 | 5.5b,c | 3 | 5 | 8 | |
5 | 14 | M/49 | AML | MUD | 2 | 0 | 5b | 1.5 | 2.5 | 3 |
15 | F/50 | AML | MSD | 2 | 0 | 5b,c | 4 | 6 | 9 | |
16 | F/49 | RAEB-2 | MSD | 2 | 0 | 5b | 7.5 | 8 | 11c |
GVHD graft-versus-host disease, RAEB refractory anemia with excess blast, MSD matched sibling donor, PMUD partially matched unrelated donor, MUD matched unrelated donor
aAssessed at the time of decitabine initiation
bIndividual dose titration (IDT) by the PK-PD model was not applied
cThe cycles where grade 4 toxicities occurred