M

M.S., S.S., and A.H. (0.9)01 (0.6)Additional01 (1.9)1 (0.6)Initial diagnosis to randomization (months)Mean (SD)54.7 (57.8)64.9 (58.7)58.1 (58.1)Median40.145.941.1Range(0.0, 405.4)(3.8, 283.5)(0.0, 405.4)Initial diagnosis, (%)CLL100 (94.3)51 (94.4)151 (94.4)SLL6 (5.7)3 ITX3 (5.6)9 (5.6)Baseline Rai stage (CLL only), (%) (%) (%)Yes69 (65.1)42 (77.8)111 (69.4)Failed to respond28 (26.4)12 (22.2)40 (25.0)Relapse 6?months9 (8.5)7 (13.0)16 (10.0)Relapse 6 to ITX3 12?months5 (4.7)6 (11.1)11 (6.9)Relapse 12 to 24?months13 (12.3)6 (11.1)19 (11.9)Relapse 24?months10 (9.4)9 (16.7)19 (11.9)Not evaluable/unfamiliar4 (3.8)2 (3.7)6 (3.8)No37 (34.9)12 (22.2)49 (30.6)Quantity of prior CLL/SLL therapies (%)155 (52.4)23 (42.6)78 (49.1)224 (22.9)11 (20.4)35 (22.0)326 (24.8)20 (37.0)46 (28.9)Mean (SD)2.0 (1.7)2.2 (1.4)2.1 (1.6)Previous rituximab treatment, (%)34 (32.1)24 (44.4)58 (36.3)ECOG performance status, (%)054 (50.9)23 (42.6)77 (48.1)152 (49.1)31 (57.4)83 (51.9)Bulky disease, (%)Yes (5?cm)42 (39.6)28 (51.9)70 (43.8)No ( 5?cm)64 (60.4)26 (48.1)90 (56.3)Chromosome 11q deletion, (%)Yes22 (20.8)12 (22.2)34 ITX3 (21.3)No84 (79.2)42 (77.8)126 (78.8)Chromosome 17p deletion, (%)Yes23 (21.7)13 (24.1)36 (22.5)No83 (78.3)41 (75.9)124 (77.5)IGVH status, (%)Mutated33 (31.1)16 (29.6)49 (30.6)Unmutated63 (59.4)35 (64.8)98 (61.3)Unevaluable10 (9.4)3 (5.6)13 (8.1)Cytopenia at baselinea, (%)Yes82 (77.4)43 (79.6)125 (78.1)Platelet count 100,000/ em /em L69 (65.1)32 (59.3)101 (63.1)Hgb 11?g/dL49 (46.2)32 (59.3)81 (50.6)ANC 1500/ em /em L15 (14.2)18 (33.3)33 (20.6)No24 (22.6)11 (20.4)35 (21.9) Open in a separate window ANC, absolute neutrophil TMOD2 count; CLL, ITX3 chronic lymphocytic leukemia; ECOG, Eastern Cooperative Oncology Group; Hgb, hemoglobin; IGVH, immunoglobulin weighty chain variable region; ITT, intention\to\treat; SD, standard deviation; SLL, small lymphocytic lymphoma. aCytopenia defined as platelet count 100,000/ em /em L, Hgb 11?g/dL, or ANC 1500/ em /em L. Percentages were calculated with the number of individuals in the ITT analysis set in each treatment group with nonmissing ideals for the parameter as the denominator. In January 2016, a planned interim analysis was carried out after 48 PFS events were observed; the clinical cutoff day was 1 December 2015. The self-employed data monitoring committee (DMC) examined the unblinded security and effectiveness data and confirmed the prespecified statistical boundary for early effectiveness preventing was crossed. The DMC recommended early analysis and preventing of the study for effectiveness. We ITX3 carried out an updated analysis that included follow\up data having a cutoff day of 14 April 2016. The data from your updated analysis with longer follow\up will become offered here; data from your interim analysis and updated analysis were consistent (Table S2). At the data cutoff day of 14 April 2016, 36 individuals from your rituximab arm completed all six cycles of treatment. Early treatment discontinuation was reported for 32 (30.2%) ibrutinib\treated individuals and 16 (29.6%) rituximab\treated individuals (Fig. S3). The reasons for treatment discontinuation in the ibrutinib arm were AEs (12.3%), PD/relapse (9.4%), withdrawal of consent (5.7%), and death (2.8%); the reasons for treatment discontinuation in the rituximab arm were PD/relapse (9.3%), AEs (7.4%), withdrawal of consent (7.4%), and death (5.6%). Twenty (37.0%) individuals in the rituximab arm crossed over to receive next collection ibrutinib treatment after confirmed PD. The median duration of exposure (measured from your first day of study drug dose to the last day of study drug dose) was 16.4?weeks for ibrutinib and 4.6?weeks for rituximab. Seventy\two (67.9%) individuals in the ibrutinib arm and no individuals in the rituximab arm remained on treatment. Effectiveness In the updated analysis, 64 PFS events were reported (26 [24.5%] in the ibrutinib arm and 38 [70.4%] in the rituximab arm). PFS was significantly improved for individuals in the ibrutinib arm compared with the rituximab arm (HR?=?0.180, 95% CI: 0.105C0.308; em P? /em em ? /em 0.0001). The median PFS was not reached in the ibrutinib arm; median PFS for the rituximab arm was 8.3?weeks (range, 0C22.6?weeks). In the 18\month landmark, the estimated PFS rate in the ibrutinib arm was 74.0%, and in the rituximab arm, it was 11.9% (Fig.?1A). Open in a separate window Number 1 (A) KaplanCMeier Curves for Progression\Free Survival (ITT Populace). The median progression\free survival (PFS) was not reached in.