Dose-limiting toxicities and response or hematologic improvement by cohort
| Cohort . | Dose, mg . | N . | N with DLT . | DLT . | Response or improvement . | Cytogenetics . | Cycle of response or improvement . | Duration of response or improvement, wk . |
|---|---|---|---|---|---|---|---|---|
| 1 | 100 (3×/d) | 3 | 0 | NA | 1 CRi | 47 (+8) | 4 | 0.1 |
| 2 | 150 (3×/d) | 3 | 0 | NA | — | — | — | — |
| 3 | 200 (3×/d) | 12 | 1 | Grade 3 fatigue | 1 CR | Diploid | 2 | 9 |
| 3 | — | — | — | Grade 3 nausea | 1 CRi | Diploid | 1 | 2 |
| 3 | — | — | — | — | 2 HI | Hyper + other, pseudodiploid | 3, 1 | 3, 9* |
| 4 | 250 (3×/d) | 7 | 0 | NA | — | — | — | — |
| 5 | 300 (3×/d) | 3 | 2 | Grade 2 vomiting | — | — | — | — |
| 5 | — | — | — | Grade 3 diarrhea | — | — | — | — |
| 5 | — | — | — | Grade 3 vomiting | — | — | — | — |
| 6 | 300 (2×/d) | 7 | 3 | Grade 3 fatigue (2) | — | — | — | — |
| 6 | — | — | — | Grade 3 nausea | — | — | — | — |
| 6 | — | — | — | Grade 3 vomiting | — | — | — | — |
| 6a | 200 (2×/d) | 6 | 1 | Grade 3 fatigue | 1 CR | Diploid | 8 | 53* |
| 6a | — | — | — | — | 1 HI | 47 (+8) | 2 | 6* |
| Cohort . | Dose, mg . | N . | N with DLT . | DLT . | Response or improvement . | Cytogenetics . | Cycle of response or improvement . | Duration of response or improvement, wk . |
|---|---|---|---|---|---|---|---|---|
| 1 | 100 (3×/d) | 3 | 0 | NA | 1 CRi | 47 (+8) | 4 | 0.1 |
| 2 | 150 (3×/d) | 3 | 0 | NA | — | — | — | — |
| 3 | 200 (3×/d) | 12 | 1 | Grade 3 fatigue | 1 CR | Diploid | 2 | 9 |
| 3 | — | — | — | Grade 3 nausea | 1 CRi | Diploid | 1 | 2 |
| 3 | — | — | — | — | 2 HI | Hyper + other, pseudodiploid | 3, 1 | 3, 9* |
| 4 | 250 (3×/d) | 7 | 0 | NA | — | — | — | — |
| 5 | 300 (3×/d) | 3 | 2 | Grade 2 vomiting | — | — | — | — |
| 5 | — | — | — | Grade 3 diarrhea | — | — | — | — |
| 5 | — | — | — | Grade 3 vomiting | — | — | — | — |
| 6 | 300 (2×/d) | 7 | 3 | Grade 3 fatigue (2) | — | — | — | — |
| 6 | — | — | — | Grade 3 nausea | — | — | — | — |
| 6 | — | — | — | Grade 3 vomiting | — | — | — | — |
| 6a | 200 (2×/d) | 6 | 1 | Grade 3 fatigue | 1 CR | Diploid | 8 | 53* |
| 6a | — | — | — | — | 1 HI | 47 (+8) | 2 | 6* |
CR indicates complete response (neutrophils of at least 104/L, platelets more than 106/L, and marrow blasts less than 5% lasting at least 4 weeks); CRi, CR with incomplete blood count recovery (marrow blasts <5%, with peripheral neutrophils of at least 104/L or platelets greater than 106/L); Grade, grade based on National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0.31 ; HI, hematologic improvement (>50% decrease in blast counts with incomplete blood count recovery); NA, not applicable; and —, no data.
*Patient went on to bone marrow transplantation.