Baseline clinical characteristics of patients
| Characteristic . | Treatment-naive at enrollment, no. (%) . | Previously treated at enrollment, no. (%) . |
|---|---|---|
| Sample size (178 total) | 139 | 39 |
| Age, y | ||
| Median | 62 | 64 |
| Range | 35-85 | 52-82 |
| Sex | ||
| Female | 45 (32) | 9 (23) |
| Male | 94 (68) | 30 (77) |
| Rai stage | ||
| Low, 0 | 57 (41) | 8 (20) |
| Intermediate, I-II | 76 (55) | 24 (62) |
| High, III-IV | 6 (4) | 7 (18) |
| Time from diagnosis to enrollment, mo | ||
| Median | 12 | 42 |
| Range | 0-306 | 4.5-244 |
| Time from enrollment to analysis, mo | ||
| Median | 18 | 18 |
| Range | 1-32 | 1-31.5 |
| IgVH mutational status | ||
| Unmutated, 97% or more homology to germ line | 65 (47) | 25 (64) |
| Mutated, less than 97% homology to germ line | 70 (50) | 14 (36) |
| Not evaluable (97% cutoff) | 4 (3) | 0 (0) |
| Unmutated, 98% or more homology to germ line | 58 (42) | 21 (54) |
| Mutated, less than 98% homology to germ line | 77 (55) | 18 (46) |
| Not evaluable (98% cutoff) | 4 (3) | 0 (0) |
| Prioritized interphase FISH | ||
| 17p deletion | 10 (7) | 5 (13) |
| 11q deletion | 11 (8) | 5 (13) |
| 12q trisomy | 20 (14) | 11 (28) |
| Normal karyotype | 34 (25) | 7 (18) |
| 13q deletion (sole abnormality) | 64 (46) | 11 (28) |
| Multiple cytogenetic abnormalities | 20 (14) | 14 (36) |
| ZAP-70 expression | ||
| Negative, 20% or less | 80 (58) | 13 (33) |
| Positive, more than 20% | 59 (42) | 26 (67) |
| p53 Mutation | ||
| Unmutated | 127 (91) | 32 (82) |
| Mutated | 12 (9) | 7 (18) |
| CD38 expression | ||
| Negative, less than 7% | 81/139 (58) | 13 (33) |
| Positive, 7% or more | 57/139 (41) | 25 (64) |
| Not evaluable (7% cutoff) | 1/139 (1) | 1 (3) |
| Negative, less than 30% | 105 (75) | 17 (43) |
| Positive, 30% or more | 33 (24) | 21 (54) |
| Not evaluable (30% cutoff) | 1 (1) | 1 (3) |
| No. of prior therapies | ||
| Median | NA | 1 |
| Range | NA | 1-7 |
| Types of prior therapies | ||
| Chemoimmunotherapy | 33 (69) | |
| Purine analogues only | 5 (10) | |
| Alkylator only | 5 (10) | |
| Monoclonal antibody only | 5 (10) |
| Characteristic . | Treatment-naive at enrollment, no. (%) . | Previously treated at enrollment, no. (%) . |
|---|---|---|
| Sample size (178 total) | 139 | 39 |
| Age, y | ||
| Median | 62 | 64 |
| Range | 35-85 | 52-82 |
| Sex | ||
| Female | 45 (32) | 9 (23) |
| Male | 94 (68) | 30 (77) |
| Rai stage | ||
| Low, 0 | 57 (41) | 8 (20) |
| Intermediate, I-II | 76 (55) | 24 (62) |
| High, III-IV | 6 (4) | 7 (18) |
| Time from diagnosis to enrollment, mo | ||
| Median | 12 | 42 |
| Range | 0-306 | 4.5-244 |
| Time from enrollment to analysis, mo | ||
| Median | 18 | 18 |
| Range | 1-32 | 1-31.5 |
| IgVH mutational status | ||
| Unmutated, 97% or more homology to germ line | 65 (47) | 25 (64) |
| Mutated, less than 97% homology to germ line | 70 (50) | 14 (36) |
| Not evaluable (97% cutoff) | 4 (3) | 0 (0) |
| Unmutated, 98% or more homology to germ line | 58 (42) | 21 (54) |
| Mutated, less than 98% homology to germ line | 77 (55) | 18 (46) |
| Not evaluable (98% cutoff) | 4 (3) | 0 (0) |
| Prioritized interphase FISH | ||
| 17p deletion | 10 (7) | 5 (13) |
| 11q deletion | 11 (8) | 5 (13) |
| 12q trisomy | 20 (14) | 11 (28) |
| Normal karyotype | 34 (25) | 7 (18) |
| 13q deletion (sole abnormality) | 64 (46) | 11 (28) |
| Multiple cytogenetic abnormalities | 20 (14) | 14 (36) |
| ZAP-70 expression | ||
| Negative, 20% or less | 80 (58) | 13 (33) |
| Positive, more than 20% | 59 (42) | 26 (67) |
| p53 Mutation | ||
| Unmutated | 127 (91) | 32 (82) |
| Mutated | 12 (9) | 7 (18) |
| CD38 expression | ||
| Negative, less than 7% | 81/139 (58) | 13 (33) |
| Positive, 7% or more | 57/139 (41) | 25 (64) |
| Not evaluable (7% cutoff) | 1/139 (1) | 1 (3) |
| Negative, less than 30% | 105 (75) | 17 (43) |
| Positive, 30% or more | 33 (24) | 21 (54) |
| Not evaluable (30% cutoff) | 1 (1) | 1 (3) |
| No. of prior therapies | ||
| Median | NA | 1 |
| Range | NA | 1-7 |
| Types of prior therapies | ||
| Chemoimmunotherapy | 33 (69) | |
| Purine analogues only | 5 (10) | |
| Alkylator only | 5 (10) | |
| Monoclonal antibody only | 5 (10) |
NA indicates not available.