Table 1. Patient Characteristics in the ITT population.
| Characteristic (n) | ITT Population (n = 165) | |
|---|---|---|
| Number | % | |
| Age, years (standard deviation) | 60.8 (9.5) | |
| Male Gender | 128 | 78 |
| Race | ||
| Caucasian | 148 | 90 |
| Black | 10 | 6 |
| Asian | 1 | 1 |
| Other | 6 | 4 |
| Creatinine Clearance (mL/min, 159) | 98.2 (34.7) | |
| ≥ 30 - < 50 | 6 | 4 |
| ≥ 50 - ≤ 80 | 50 | 31 |
| > 80 | 103 | 65 |
| ECOG Performance Status (159) | ||
| 0 | 65 | 41 |
| 1 | 74 | 47 |
| 2 | 20 | 13 |
| Rai Stage (150) | ||
| I, II | 29 | 19 |
| III, IV | 121 | 81 |
| Binet Stage (109) | ||
| A | 3 | 3 |
| B, C | 106 | 97 |
| Bulky Lymphadenopathya | 115 | 70 |
| Cytogenetic Abnormalitiesb | ||
| del(17p) (141) | 49 | 35% |
| del(11q) (145) | 43 | 31% |
| Number of prior therapies (range) | 4 (1 – 12) | |
| Prior Therapies | ||
| Alkylating agent | 163 | 99 |
| Fludarabine | 165 | 100 |
| Rituximab | 143 | 87 |
| Alemtuzumab | 62 | 38 |
| Fludarabine refractory | 158 | 96 |
a
Defined as at least 1 lymph node > 5 cm in longest diameter by cross sectional imaging at study registration.
b
Classified according to Döhner, et al31.