Disease characteristics at enrollment (n = 93)
| Characteristics . | n (%) . | Overall response (CR + PR, %) . |
|---|---|---|
| Median age (y, range) | 66 (31-86) | 2 + 29 (33) |
| Patients > 70 y | 26 (28) | 1 + 7 (31) |
| Rai stage | ||
| 0 | 1 (1) | 0 |
| I | 5 (5) | 0 + 2 (40) |
| II | 16 (17) | 0 + 7 (44) |
| III | 16 (17) | 2 + 6 (50) |
| IV | 55 (59) | 0 + 14 (25) |
| Lymph node involvement | ||
| No involvement | 22 (23) | 0 + 8 (36) |
| All < 2 cm in diameter | 25 (27) | 1 + 10 (44) |
| At least one node 2-5 cm in diameter | 29 (31) | 1 + 9 (34) |
| At least one node > 5 cm in diameter | 17 (18) | 0 + 2 (12) |
| Hepatomegaly | 34 (37) | 0 + 9 (26) |
| Splenomegaly | 51 (55) | 2 + 14 (31) |
| Splenectomy | 16 (17) | 0 + 5 (31) |
| B-symptoms | 39 (42) | 1 + 8 (23) |
| WHO performance status | ||
| 0 | 24 (26) | 2 + 9 (49) |
| 1 | 50 (54) | 0 + 20 (40) |
| 2 | 19 (20) | 0 |
| Median duration since CLL diagnosis | 6.1 | NA |
| (y, range) | (0.7-37.0) | |
| Hemoglobin ≤ 11.0 g/dL | 57 (61) | 2 + 13 (26) |
| ANC < 1.5 109/L | 24 (26) | 1 + 4 (21) |
| Platelets ≤ 100 × 109/L* | 54 (58) | 0 + 13 (24) |
| Previous therapy | ||
| Never responded to fludarabine | 45 (48) | 1 + 12 (29) |
| Response to fludarabine†,‡ | 48 (52) | 1 + 18 (38) |
| Number of prior therapies1-153 | ||
| 2 | 26 (28) | 1 + 8 (35) |
| 3 | 28 (30) | 1 + 8 (32) |
| 4 | 25 (27) | 0 + 10 (40) |
| > 4 | 14 (15) | 0 + 3 (21) |
| Characteristics . | n (%) . | Overall response (CR + PR, %) . |
|---|---|---|
| Median age (y, range) | 66 (31-86) | 2 + 29 (33) |
| Patients > 70 y | 26 (28) | 1 + 7 (31) |
| Rai stage | ||
| 0 | 1 (1) | 0 |
| I | 5 (5) | 0 + 2 (40) |
| II | 16 (17) | 0 + 7 (44) |
| III | 16 (17) | 2 + 6 (50) |
| IV | 55 (59) | 0 + 14 (25) |
| Lymph node involvement | ||
| No involvement | 22 (23) | 0 + 8 (36) |
| All < 2 cm in diameter | 25 (27) | 1 + 10 (44) |
| At least one node 2-5 cm in diameter | 29 (31) | 1 + 9 (34) |
| At least one node > 5 cm in diameter | 17 (18) | 0 + 2 (12) |
| Hepatomegaly | 34 (37) | 0 + 9 (26) |
| Splenomegaly | 51 (55) | 2 + 14 (31) |
| Splenectomy | 16 (17) | 0 + 5 (31) |
| B-symptoms | 39 (42) | 1 + 8 (23) |
| WHO performance status | ||
| 0 | 24 (26) | 2 + 9 (49) |
| 1 | 50 (54) | 0 + 20 (40) |
| 2 | 19 (20) | 0 |
| Median duration since CLL diagnosis | 6.1 | NA |
| (y, range) | (0.7-37.0) | |
| Hemoglobin ≤ 11.0 g/dL | 57 (61) | 2 + 13 (26) |
| ANC < 1.5 109/L | 24 (26) | 1 + 4 (21) |
| Platelets ≤ 100 × 109/L* | 54 (58) | 0 + 13 (24) |
| Previous therapy | ||
| Never responded to fludarabine | 45 (48) | 1 + 12 (29) |
| Response to fludarabine†,‡ | 48 (52) | 1 + 18 (38) |
| Number of prior therapies1-153 | ||
| 2 | 26 (28) | 1 + 8 (35) |
| 3 | 28 (30) | 1 + 8 (32) |
| 4 | 25 (27) | 0 + 10 (40) |
| > 4 | 14 (15) | 0 + 3 (21) |
All patients included in the study had received alkylating agents and had failed fludarabine.
One patient had a baseline central lab with platelets of 100 × 109/L, but was assessed as Rai IV based on a local lab at baseline of 94 × 109/L and the investigator assessment of Rai IV on inclusion criteria.
Failed fludarabine and/or other purine analog, including cladribine (n = 3) and nelarabine (n = 2) as final treatment.
One patient did not fail by protocol definition, because progression occurred 10 months, not 6 months after therapy.
Each regimen was counted only once, regardless of the number of courses administered or relapse and retreatment.