Table 1.
Baseline Characteristics of Patients With Refractory CLL Treated With Ofatumumab
| Characteristic | FA-ref (n = 59) |
BF-ref (n = 79) |
||
|---|---|---|---|---|
| No. of Patients | % | No. of Patients | % | |
| Age, years | ||||
| Median | 64 | 62 | ||
| Range | 41-86 | 43-84 | ||
| Sex | ||||
| Male | 44 | 75 | 57 | 72 |
| Female | 15 | 25 | 22 | 28 |
| No. of prior treatments | ||||
| Median | 5 | 4 | ||
| Range | 1-14 | 1-16 | ||
| Duration of CLL, years | ||||
| Median | 6 | 6 | ||
| Range | 1-18.6 | 0.7-18.0 | ||
| Largest lymph node > 5 cm based on clinical evaluation | 11 | 19 | 36 | 46 |
| Largest lymph node > 5 cm by palpation or CT scan | 55 | 93 | 79 | 100 |
| Rai stage at screening | ||||
| 0 | 1 | 2 | 0 | 0 |
| I or II | 26 | 44 | 24 | 30 |
| III or IV | 32 | 54 | 55 | 70 |
| Binet stage at screening | ||||
| A | 6 | 10 | 4 | 5 |
| B | 23 | 39 | 24 | 30 |
| C | 30 | 51 | 51 | 65 |
| ECOG PS | ||||
| 0 | 27 | 46 | 25 | 32 |
| 1-2 | 31* | 53 | 54 | 68 |
| Prior alkylating therapy | 55 | 93 | 73 | 92 |
| Prior rituximab-containing regimen | 35 | 59 | 43 | 54 |
Abbreviations: CLL, chronic lymphocytic leukemia; FA-ref, fludarabine and alemtuzumab refractory; BF-ref, bulky fludarabine refractory; CT, computed tomography; ECOG, Eastern Cooperative Oncology Group; PS, performance status.
*
One patient in the FA-ref group had ECOG PS of 3 at baseline as a result of elbow surgery unrelated to CLL and was allowed to enroll onto the study.