Table 3.
Complete and Overall Response Rates, According to Cohort and Subgroup.
Variable | No. of Patients | Complete Response Rate* | Overall Response Rate |
---|---|---|---|
percent of patients (95% CI) | |||
All patients | 116 | 20 (13–28) | 79 (71–86) |
Dose-escalation cohort | 56 | 30 (19–44) | 77 (64–87) |
Expansion cohort | 60 | 10 (4–21) | 82 (70–91) |
Age | |||
≥70 yr | 34 | 21 (9–38) | 71 (53–85) |
<70 yr | 82 | 20 (12–30) | 83 (73–90) |
No. of previous therapies | |||
≥4 | 56 | 16 (8–28) | 73 (60–84) |
<4 | 60 | 23 (13–36) | 85 (73–93) |
Fludarabine resistance | |||
Yes | 70 | 16 (8–26) | 79 (67–88) |
No | 44 | 27 (15–43) | 82 (67–92) |
Bulky nodes of >5 cm | |||
Yes | 67 | 8 (3–17) | 78 (66–87) |
No | 48 | 38 (24–53) | 83 (70–93) |
Chromosome 17p deletion | |||
Yes | 31 | 16 (6–34) | 71 (52–86) |
No | 60 | 18 (10–30) | 80 (68–89) |
Chromosome 11q deletion | |||
Yes | 28 | 11 (2–28) | 82 (63–94) |
No | 62 | 21 (12–33) | 76 (63–86) |
IGHV status | |||
Unmutated | 46 | 17 (8–31) | 76 (61–87) |
Mutated | 17 | 29 (10–56) | 94 (71–100) |
A complete response includes complete remission with incomplete count recovery.