Best protocol response
| Dose level . | Dose, µg/kg . | Number treated . | Number evaluable . | cCR . | PR . | Hematologic activity . | Stable disease . | Progressive disease . | Not evaluable . |
|---|---|---|---|---|---|---|---|---|---|
| 1A | 5 | 1 | 1 | 1 | |||||
| 2A | 10 | 1 | 1 | 1 (CRi) | |||||
| 3A | 20 | 1 | 1 | 1 | |||||
| 3B | 20 | 4 | 4 | 1 | 2 | 1 | |||
| 4A | 30 | 4 | 4 | 3 | 1 | ||||
| 4B | 30 | 5 | 4 | 1 (MRD negative) | 1 | 1 | 1 | 1 | |
| 5B | 40 | 8 | 7 | 1 (MRD negative) | 3 | 2 | 1 | 1 | |
| 5C | 32* (40) | 11 | 7 | 2 | 1 | 1 | 1 | 2 | 4 |
| 6B | 50 | 6 | 6 | 2 (1 MRD negative) | 1 | 3 | |||
| 6C | 50 | 14 | 12 | 2 CR (1 MRD negative), 1 CRi (MRD negative) | 2 | 1 | 5 | 1 | 2 |
| 55 | 47 | 11 (23%) | 4 (9%) | 11 (23%) | 12 (26%) | 9 (19%) | 8 |
| Dose level . | Dose, µg/kg . | Number treated . | Number evaluable . | cCR . | PR . | Hematologic activity . | Stable disease . | Progressive disease . | Not evaluable . |
|---|---|---|---|---|---|---|---|---|---|
| 1A | 5 | 1 | 1 | 1 | |||||
| 2A | 10 | 1 | 1 | 1 (CRi) | |||||
| 3A | 20 | 1 | 1 | 1 | |||||
| 3B | 20 | 4 | 4 | 1 | 2 | 1 | |||
| 4A | 30 | 4 | 4 | 3 | 1 | ||||
| 4B | 30 | 5 | 4 | 1 (MRD negative) | 1 | 1 | 1 | 1 | |
| 5B | 40 | 8 | 7 | 1 (MRD negative) | 3 | 2 | 1 | 1 | |
| 5C | 32* (40) | 11 | 7 | 2 | 1 | 1 | 1 | 2 | 4 |
| 6B | 50 | 6 | 6 | 2 (1 MRD negative) | 1 | 3 | |||
| 6C | 50 | 14 | 12 | 2 CR (1 MRD negative), 1 CRi (MRD negative) | 2 | 1 | 5 | 1 | 2 |
| 55 | 47 | 11 (23%) | 4 (9%) | 11 (23%) | 12 (26%) | 9 (19%) | 8 |
Response rates based on evaluable population (response criteria listed in Table 1). Cohorts: A: every other day × 6 doses, no steroids; B: every other day × 6 doses, dexamethasone prophylaxis cycle 1; C: every other day × 10 doses, dexamethasone prophylaxis cycle 1, doses 1 to 6.
CRi, CR with incomplete blood count recovery.
32 µg/kg process 3 equivalent bioactivity to 40 µg/kg of prior product.