Nonhematologic toxicities for 55 adults with relapsed and refractory acute leukemia
| Dose level, mg/m2 (no. of patients) . | Tumor lysis . | Mucositis . | Increase in bilirubin . | Cardiac . | Documented infection . | Death* . | |
|---|---|---|---|---|---|---|---|
| Oral . | GI . | ||||||
| 1. 20/30 (6) | 1 | 3 (2 grade 3) | 0 (1 grade 3) | 4 | 2 | 5 | 0 |
| 2. 25/35 (10) | 4 (1 grade 5) | 1 | 2 (1 grade 3) | 3 (2 grade 3) | 2 (2 grade 3/4)† | 5 (1 grade 5) | 2 |
| 3. 30/40 (6) | 2 | 0 | 5 | 1 | 0 | 3 | 0 |
| 4. 30/50 (6) | 5 (1 grade 3) | 1 | 2 | 0 | 0 | 3 | 0 |
| 5. 30/60 (25)‡ | |||||||
| (6) | 5 (1 grade 3) | 1 | 2 | 2 (1 grade 3) | 0 | 3 | 0 |
| (19) | 9 (1 grade 3) | 2 (1 grade 3) | 5 | 3 (2 grade 3) | 1 (grade 3)§ | 7 (2 grade 5) | 2 |
| 6. 30/70 (2)‖ | 2 (1 grade 4) | 2 (1 grade 4) | 2 (1 grade 3) | 1 (1 grade 4) | 0 | 1 (1 grade 5) | 1 |
| Grade 3-5 toxicity | 5 (9%) | 4 (7%) | 2 (4%) | 6 (11%)¶ | 2 (4%) | 4 (7%) | 5 (9%)# |
| Total | 28 (51%) | 10 (18%) | 18 (33%) | 14 (25%) | 5 (9%) | 27 (49%) | 5 (9%) |
| Dose level, mg/m2 (no. of patients) . | Tumor lysis . | Mucositis . | Increase in bilirubin . | Cardiac . | Documented infection . | Death* . | |
|---|---|---|---|---|---|---|---|
| Oral . | GI . | ||||||
| 1. 20/30 (6) | 1 | 3 (2 grade 3) | 0 (1 grade 3) | 4 | 2 | 5 | 0 |
| 2. 25/35 (10) | 4 (1 grade 5) | 1 | 2 (1 grade 3) | 3 (2 grade 3) | 2 (2 grade 3/4)† | 5 (1 grade 5) | 2 |
| 3. 30/40 (6) | 2 | 0 | 5 | 1 | 0 | 3 | 0 |
| 4. 30/50 (6) | 5 (1 grade 3) | 1 | 2 | 0 | 0 | 3 | 0 |
| 5. 30/60 (25)‡ | |||||||
| (6) | 5 (1 grade 3) | 1 | 2 | 2 (1 grade 3) | 0 | 3 | 0 |
| (19) | 9 (1 grade 3) | 2 (1 grade 3) | 5 | 3 (2 grade 3) | 1 (grade 3)§ | 7 (2 grade 5) | 2 |
| 6. 30/70 (2)‖ | 2 (1 grade 4) | 2 (1 grade 4) | 2 (1 grade 3) | 1 (1 grade 4) | 0 | 1 (1 grade 5) | 1 |
| Grade 3-5 toxicity | 5 (9%) | 4 (7%) | 2 (4%) | 6 (11%)¶ | 2 (4%) | 4 (7%) | 5 (9%)# |
| Total | 28 (51%) | 10 (18%) | 18 (33%) | 14 (25%) | 5 (9%) | 27 (49%) | 5 (9%) |
Death within 60 days of the start of chemotherapy.
Gade 3 pericarditis, grade 4 atrial fibrillation with rapid ventricular response.
Dose level 5: 6 patients in dose-escalation phase, 19 patients in expansion phase.
Grade 3 LVEF decrease.
Both patients had grade 4 toxicity in one or more parameters (1 grade 5).
Hyperbilirubinemia: 4 tumor lysis, 2 overwhelming infection.
Four with infection and 1 multiorgan failure (tumor lysis).