Table 1.
Alemtuzumab single-agent trials in relapsed/refractory chronic lymphocytic leukemia (CLL).
| Trial | No. enrolled | Median prior lines (range) | ORR, % (CR, %) | Median OS, months | Median PFS, months | Patient characteristics |
|---|---|---|---|---|---|---|
| Osterborg et al. [1997] | 29 | nr | 41 (3) | nr | 12* | r/r |
| Keating [2002] (CAM-211) | 93 | 3 (2–4$) | 33 (2) | 16 | 4.7 | Fludarabine r/r |
| Rai et al. [2002] | 24 (23 CLL, 1 T-PLL) | 3 (1–8) | 33 (0) | 35.8 | 19.6 | Fludarabine refractory |
| Ferrajoli et al. [2003] | 78 (42 CLL, 18 T-PLL, 18 others) | 3 (1–9)$ | 31 (5)* | 12‡ | Nr | Relapsed or no established frontline therapy |
| Lozanski et al. [2004] | 36 | 3 (1–12) | 31 (6) | nr | 10§ | 81% fludarabine r/r |
| Rawstron et al. [2004] | 43 | 3 (1–7) | 37 (21) | nr | Nr | r/r to purine analogs |
| Moreton et al. [2005] | 91¶ | 3 (1–8) | 54 (35) | nr but MRD better | Nr | r/r |
| Ionita et al. [2009] | 27 | 3 (1–6) | 33 (7.4) | 19.1 | 7.7 | Fludarabine refractory |
| Total number treated | 421 |
Only trials with enrollment of 20 or more patients are shown. Unless otherwise noted, all patients have CLL.
*
Response duration.
$
Patients with CLL only.
‡
All patients.
§
Responders.
¶
Seven received subcutaneous treatment.
CR, complete response; MRD, minimal residual disease; nr, not reported; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; r/r, relapsed/refractory; T-PLL, T-cell prolymphocytic leukemia.