Table 2. Dose escalation scheme, best responses, and dose-limiting toxicities during phase 1.
Dose Level | Decitabine | Patients (n) | Best Response | Dose-limiting toxicities |
---|---|---|---|---|
1 | 5 days | 6 | 1 CR, 2 CRp, 1 RD, 2 DI | --- |
2 | 7 days | 12 | 5 CR, 1 CRp, 1 CRi, 3 RD, 2 DI* | Respiratory failure/shock (1) |
3 | 10 days | 12 | 3 CR, 2 CRp, 3 MLFS, 4 RD | Respiratory failure/shock (1) |
1 patient died before receiving MEC
Abbreviations: CR, complete remission; CRi, complete remission with incomplete blood count recovery; CRp, complete remission with incomplete platelet recovery; DI: death from indeterminate cause; MLFS, morphologic-leukemia free state; RD, resistant disease