Phase 3 CLL cladribine studies: untreated patients
| Study/regimen . | No. of patients . | Cladribine dose . | Response, % . | Median duration, mo . | OS, mo . | |
|---|---|---|---|---|---|---|
| OR . | CR . | |||||
| Robak et al (2000)86 | ||||||
| 2-CdA + P | 126 | A | 87 | 47 | 24 (P = .01): 46% | 24 (P = .6): 78% |
| Chl + P | 103 | 12 mg/m2/d PO + 30 mg/m2/d PO for 7 days | 57 | 12 | 24 (33%) | 24: 82% |
| Robak et al (2006)87 | ||||||
| 2-CdA | 166 | B | 77 | 21 | 24 (P = .47) | 51 (P = .73) |
| 2-CdA + Cy | 162 | C | 83 | 29 | 22 (P = .49) | Not yet reached |
| 2-CdA + Cy + M | 151 | D | 80 | 36 | 24 | Not yet reached |
| Karlsson et al (2007)85 | ||||||
| 2-CdA | 72 | E | 75 | NA | 25 (P < .001) | 82 (NS) |
| F | 73 | 25 mg/m2/d IV for 5 days | 70 | NA | 10 | 68 |
| Chl | 76 | 10 mg/m2/d PO for 10 days | 62 | NA | 9 | 62 |
| Robak et al (2010)88 | ||||||
| 2-CdA + Cy | 212 | F | 88 | 47 | 28 (P = .51) | 48 (P = .16): 62% |
| F + Cy | 211 | 25 mg/m2/d IV + 250 mg/m2/d IV for 3 days | 82 | 46 | 27 | 48: 61% |
| Study/regimen . | No. of patients . | Cladribine dose . | Response, % . | Median duration, mo . | OS, mo . | |
|---|---|---|---|---|---|---|
| OR . | CR . | |||||
| Robak et al (2000)86 | ||||||
| 2-CdA + P | 126 | A | 87 | 47 | 24 (P = .01): 46% | 24 (P = .6): 78% |
| Chl + P | 103 | 12 mg/m2/d PO + 30 mg/m2/d PO for 7 days | 57 | 12 | 24 (33%) | 24: 82% |
| Robak et al (2006)87 | ||||||
| 2-CdA | 166 | B | 77 | 21 | 24 (P = .47) | 51 (P = .73) |
| 2-CdA + Cy | 162 | C | 83 | 29 | 22 (P = .49) | Not yet reached |
| 2-CdA + Cy + M | 151 | D | 80 | 36 | 24 | Not yet reached |
| Karlsson et al (2007)85 | ||||||
| 2-CdA | 72 | E | 75 | NA | 25 (P < .001) | 82 (NS) |
| F | 73 | 25 mg/m2/d IV for 5 days | 70 | NA | 10 | 68 |
| Chl | 76 | 10 mg/m2/d PO for 10 days | 62 | NA | 9 | 62 |
| Robak et al (2010)88 | ||||||
| 2-CdA + Cy | 212 | F | 88 | 47 | 28 (P = .51) | 48 (P = .16): 62% |
| F + Cy | 211 | 25 mg/m2/d IV + 250 mg/m2/d IV for 3 days | 82 | 46 | 27 | 48: 61% |
2-CdA indicates cladribine; P, prednisone; Chl, chlorambucil; Cy, cyclophosphamide; M, mitoxantrone; F, fludarabine; IV, intravenously; PO, by mouth; and NS, not significant.
A indicates 0.12 mg/kg per day 2-hour intravenous infusion for 5 consecutive days + prednisone 30 mg/m2 PO for 5 days; B, 0.12 mg/kg per day as 2-hour intravenous infusion for 5 consecutive days; C, 0.12 mg/kg per day as 2-hour intravenous infusion for 3 consecutive days + cyclophosphamide 650 mg/m2 intravenous on day 1; D, 0.12 mg/kg per day as 2-hour intravenous infusion for 3 consecutive days + cyclophosphamide 650 mg/m2 intravenous on day 1 + mitoxantrone 10 mg/m2 intravenous on day 1; E, 5 mg/m2 2-hour intravenous infusion for 5 consecutive days; and F, 0.12 mg/kg per day as 2-hour intravenous infusion for 3 consecutive days + cyclophosphamide 250 mg/m2 per day intravenous for 3 consecutive days.