Study | N | Age, median [range] | INO dosing | CR/CRi Rate | HSCT Rate | Median OS | VOD/SOS rate |
---|---|---|---|---|---|---|---|
Kantarjian H et al. 2013 [11] (Phase II) | 90 | 39.5 [4–84] | • Patients #1–49: 1.3–1.8 mg/m2 once per cycle • Patients #50–90: 0.8 mg/m2 on D1, 0.5 mg/m2 on D8 and D15 each cycle | 58% | 40% | 6.2 months | 17%a |
Deangelo DJ et al. 2017 [12] (Phase I/II) | 72 | 45 [20–79] | • Induction: 0.8 mg/m2 on D1, 0.5 mg/m2 on D8 and D15 each cycleb • Once in CR/CRi: 0.8 mg/m2 on D1, 0.4 mg/m2 on D8 and D15 each cycle | 68% | 33% | 7.4 months | 6% |
Kantarjian H et al. 2016 [1] (Phase III) | 164c | 47 [18–78] | • Induction: 0.8 mg/m2 on D1, 0.5 mg/m2 on D8 and D15 each cycle • Once in CR/CRi: 0.5 mg/m2 on D1, D8 and D15 each cycle | 80.7% | 41% | 7.7 months | 11% |