Table 1.
Characteristic | Treatment Arm |
|||
---|---|---|---|---|
OBL-FC (n = 120) |
FC (n = 121) |
|||
No. | % | No. | % | |
Sex | ||||
Male | 89 | 74 | 89 | 74 |
Race/ethnicity | ||||
White | 105 | 88 | 109 | 90 |
Black | 6 | 5 | 7 | 6 |
Hispanic | 8 | 7 | 4 | 3 |
Other | 1 | 1 | 1 | 1 |
Age, years | ||||
Median | 63 | 63 | ||
Range | 35-86 | 42-82 | ||
≥ 65 | 53 | 44 | 52 | 43 |
≥ 75 | 17 | 14 | 10 | 8 |
ECOG performance status | ||||
0 | 41 | 34 | 38 | 31 |
≥ 1 | 78 | 65 | 80 | 66 |
Unknown | 1 | 1 | 2 | 2 |
Rai stage | ||||
≤ 2 | 66 | 55 | 59 | 49 |
3-4 | 54 | 45 | 61 | 50 |
Unknown | 0 | 0 | 1 | 1 |
Median time from diagnosis, months | 70 | 58 | ||
No. of prior regimens | ||||
1-2 | 60 | 50 | 63 | 52 |
≥ 3 | 60 | 50 | 58 | 48 |
Fludarabine sensitivity | ||||
Relapsed | 51 | 43 | 50 | 41 |
Refractory | 69 | 58 | 71 | 59 |
Response to last therapy, months | ||||
> 6 | 54 | 45 | 52 | 43 |
≤ 6 | 66 | 55 | 69 | 57 |
β2 microglobulin* | ||||
< 4 | 57 | 48 | 58 | 48 |
≥ 4 | 52 | 43 | 47 | 39 |
Serum LDH level† | ||||
< ULN range | 63 | 53 | 63 | 52 |
≥ ULN range | 53 | 44 | 52 | 43 |
Platelet count, × 103/μL | ||||
< 100,000 | 43 | 36 | 43 | 36 |
≥ 100,000 | 77 | 64 | 78 | 64 |
Abbreviations: OBL-FC, oblimersen plus fludarabine/cyclophosphamide; FC, fludarabine/cyclophosphamide; ECOG, Eastern Cooperative Oncology Group; LDH, lactate dehydrogenase; ULN, upper limit of normal.
Not available for 11 patients in the OBL-FC group and 16 patients in the FC group.
Not available for four patients in the OBL-FC group and six patients in the FC group.