Table 1. Characteristics of the 11... | American Society of Hematology

Table 1.

Characteristics of the 11 patients with CLL enrolled in the 12-week pilot trial, along with dosing changes and poststudy dose

Patient no.	Age/sex	Years since diagnosis	Prior therapies	WBC ×10³/μL	ALC ×10³/μL	IGHV status	FISH	IBR dosed per protocol?	Poststudy IBR dose (mg/d)
1	69/F	9	1	33	29	Unknown	Trisomy 12	Yes	140
2	68/F	8	0	64	55	Mutated	Del13q	Yes	140*
3	68/F	7	0	179	173	Mutated	Del13q	Yes	140
4	56/M	20	3	29	24	Mutated	Del13q, trisomy 12	Yes	140
5	74/F	11	1	53	49	Unmutated	Trisomy 12	Yes	140 q.o.d.
6	67/M	2	0	153	130	Unmutated	Normal	†	140
7	53/F	2	0	33	28	Mutated	Normal	‡	420
8	73/M	8	1	67	61	Mutated	Del13q, trisomy 12	Yes	140, 280¶
9	79/M	17	4	71	62	Mutated	Del13q	Yes	140
10	79/F	10	1	34	31	Mutated	Del13q	§	—
11	52/M	13	2	45	41	Mutated	Del13q, trisomy 12	Yes	140

Patient no.	Age/sex	Years since diagnosis	Prior therapies	WBC ×10³/μL	ALC ×10³/μL	IGHV status	FISH	IBR dosed per protocol?	Poststudy IBR dose (mg/d)
1	69/F	9	1	33	29	Unknown	Trisomy 12	Yes	140
2	68/F	8	0	64	55	Mutated	Del13q	Yes	140*
3	68/F	7	0	179	173	Mutated	Del13q	Yes	140
4	56/M	20	3	29	24	Mutated	Del13q, trisomy 12	Yes	140
5	74/F	11	1	53	49	Unmutated	Trisomy 12	Yes	140 q.o.d.
6	67/M	2	0	153	130	Unmutated	Normal	†	140
7	53/F	2	0	33	28	Mutated	Normal	‡	420
8	73/M	8	1	67	61	Mutated	Del13q, trisomy 12	Yes	140, 280¶
9	79/M	17	4	71	62	Mutated	Del13q	Yes	140
10	79/F	10	1	34	31	Mutated	Del13q	§	—
11	52/M	13	2	45	41	Mutated	Del13q, trisomy 12	Yes	140

ALC, absolute lymphocyte count; F, female; FISH, fluorescent in-situ hybridization; IBR, ibrutinib; M, male; WBC, white blood cells.

Patient continued 140 mg/d IBR for 6 months and then switched to a different therapy because of fatigue.

†

Discontinued on C1D28 because of the need for surgery to repair an abdominal aortic aneurysm.

‡

Patient dose was increased to 420 mg/d because of joint pain and swelling on C3D8.

Patient continued 140 mg/d IBR for 14 months, and then the dose of IBR was increased to 280 mg/d by the treating physician.

Patient experienced IBR intolerance (headaches, arthralgias, myalgias, and weakness) in C1 and treatment was suspended for 7 days and then resumed at 280 mg/d in C2, during which time treatment was suspended again because of intolerance that responded slightly to holding of the drug, prompting her physician to discontinue IBR and take her off the study on C2D28.

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