Table 1.

Patient demographics

Cohort (dose)	Pt#	Age/sex	IgvH (% Horn)	%ZAP70+	%CD38+	Prior treatments	Cytogenetics	FISH	ECOG	Rai stage	β2M g/dL	Responsea	TNTx
1 (1 × 1010 vp)	1	49/M	92.2	29.8	0	Idiotype vaccine   conjugated with KLH	46, XY	del13q	0	II	1.6	PD	6.8
	2	55/M	96.8	36.7	0	None	46, XY	del13q	0	II	4	PR	15.5
	3	67/M	100	28.1	0	AT-101, HDMP + R, A	46, XY	del17p, del13q	0	II	1.3	SD	4.0
2 (3.3 × 1010 vp)	4	73/M	100	10.3	0	GT, X-cyte therapy,   HDMP + R, AT-101 + R	NA	del11q, del13q	0	IV	2.5	SD	3.8
	5	52/M	94	5.2	44	HDMP + R	48, XY	tri12, del13q	0	II	2.1	PR	12.5
	6b	53/M	NA	NA	NA	FM, FCR, R, A, 0	46, XY	Normal	0	II	2.5	PD	4.7
3 (1 × 1011 vp)	7	53/F	98.6	4.8	NA	None	46, XX	del11q	1	II	2.9	PR	7.0
	8b	48/M	100	33.7	NA	CP, C, F, FCR,   HDMP + R,   AT-101 + R	46, XY	del11q, del13q	0	II	3.7	PD	1.1
	9	61/M	99.3	98.7	98.7	FR, R	47, XY	Tri12	0	II	2.9	SD	2.7
4 (3.3 × 1011 vp)	10	55/F	95.7	81.5	0	FR, A, Anti-CD40   antibody, AT-101 + R	46, XX	Normal	1	IV	1.2	PD	3.0
	11	54/F	100	8.1	82	None	NA	Normal	0	II	2.2	SD	9.8
	12	45/M	NA	32.8	0	FCR, R	47, XY	tri12, del17p	0	IV	3.4	PD	1.4
3E(1 × 1010 vp)	13	57/M	100	92.5	19.3	HDMP+R	46, XY	del11q	0	IV	2.9	SD	5.0
	14	54/F	NA	NA	NA	None	46, XX	del13q	0	III	2.6	SD	5.0
	15	63/F	96.1	83.9	8.7	HDMP+R, A, Hsp90	46, XX	de!13q	0	II	2.8	SD	7.7

Abbreviations: % Horn, percentage of gene homology; A, alemtuzumab; AT-101, BCL-2 family member inhibitor; C, chlorambucil; CP, chlorambucil and prednisone; F, fludarabine: FCR, fludarabine, cyclophosphamide, and rituximab; FM, fludarabine and mitoxantrone; FR, fludarabine and rituximab; GT, gene therapy (CD154); HDMP, high-dose methylprednisolone; NA, not available; O, ofatumumab; R, rituximab; X-cyte, T-cell therapy.

^aResponse assessment was conducted on the basis of IWCLL 2008 guidelines criteria.

^bPatient fludarabine refractory based on IWCLL 2008 definition.