Table 1.

Patient demographic and baseline clinical characteristics

	PART I—single dose						PART II—multiple doses
Dose	50	83.5	139.5	210	315	Overall part I	2 doses at 210	5 doses at 210	Overall part II
Patients	(n = 6)	(n = 3)	(n = 3)	(n = 3)	(n = 3)	(n = 18)	(n = 3)	(n = 3)	(n = 6)
Age
Mean	69.2	66.0	67.0	67.0	60.0	66.4	69.0	66.7	67.8
Range	60–79	61–72	63–70	56–76	58–63	56–79	63–76	56–77	56–77
Gender (number of males, %)	2 (33 %)	2 (67 %)	2 (67 %)	2 (67 %)	3 (100 %)	11 (61 %)	2 (67 %)	2 (67 %)	4 (67 %)
Duration of disease (years)
Mean	7.6	15.0	12.7	10.4	11.0	10.7	10.7	10.8	10.7
Range	4–14	14–17	5–21	7–13	7–14	4–21	7–13	6–16	6–16
Performance status
0	3	2	2	3	1	11 (61 %)	0	2	2 (33 %)
1	2	1	1	0	2	6 (33 %)	2	1	3 (50 %)
2	1	0	0	0	0	1 (6 %)	1	0	1 (17 %)
Rai stage III–IV	1	1	2	1	1	6 (33 %)	1	0	1 (17 %)
Baseline FISH analysis
Del 13q14	4 (67 %)	3 (100 %)	1 (33 %)	0	1 (33 %)	9 (50 %)	1 (33 %)	2 (67 %)	3 (50 %)
Del 11q22–23	1 (17 %)	1 (33 %)	1 (33 %)	0	1 (33 %)	4 (22 %)	1 (33 %)	1 (33 %)	2 (33 %)
Trisomy 12	1 (17 %)	0	0	0	0	1 (6 %)	2 (67 %)	1 (33 %)	3 (50 %)
Del 17p	1 (17 %)	1 (33 %)	0	0	0	2 (11 %)	0	0	0
Number of patients with number of prior therapies >1	5	2	2	3	3	15 (83 %)	2	1	3 (50 %)
Range	1–4	1–13	1–2	2	2–6	1–13	1–7	1–4	1–7
Absolute lymphocyte count (10 9 /L)
Mean	40.5	30.1	67.2	70.2	31.2	46.6	132.3	16.5	74.5
Range	15.7–85.0	11.6–53.3	38.4–90.5	15.7–106.0	1.0–68.6	1.0–106.0	50.0–229.4	9.8–29.3	9.8–229.4
Hemoglobin (g/L)
Mean	120.3	123.3	129.0	103.7	114.7	118.5	106.0	130.7	118.3
Range	110–136	114–129	107–144	103–105	99–123	99–144	9–115	116–142	99–142