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. 2019 Jul 22;134(13):1024–1036. doi: 10.1182/blood.2018891598

Table 1.

Baseline demographic and clinical characteristics

560 mg/day ibrutinib + 375 mg/m2 IV rituximab combined with:
Dose level −1: 10 mg LEN (n = 7) Dose level 1: 15 mg LEN (n = 12) Dose level 1+: 15 mg LEN (n = 9) Dose level 2: 20 mg LEN (n = 9) Dose level 3: 25 mg LEN (n = 8) Dose level 1 combined (n = 21) All dose levels (N = 45)
Age
 Median age, y (range) 59 (49-68) 62 (43-84) 68 (41-85) 64 (50-77) 68 (36-78) 64 (41-85) 64 (36-85)
 ≥65 y, n (%) 2 (29) 5 (42) 5 (56) 4 (44) 5 (63) 10 (48) 21 (47)
Male sex, n (%) 4 (57) 8 (67) 4 (44) 4 (44) 5 (63) 12 (57) 25 (56)
White race, n (%)* 5 (71) 11 (92) 8 (89) 9 (100) 7 (88) 19 (90) 40 (89)
Mean BMI, kg/m2 (SD) 29.0 (5.80) 31.0 (10.30) 29.3 (5.10) 28.0 (5.50) 25.9 (4.49) 30.3 (8.33) 28.8 (6.90)
ECOG PS, n (%)
 0 1 (14) 7 (58) 2 (22) 3 (33) 1 (13) 9 (43) 14 (31)
 1 6 (86) 5 (42) 7 (78) 6 (67) 7 (88) 12 (57) 31 (69)
Median time from initial diagnosis, mo (range) 14.4 (6-38) 15.2 (8-83) 11.2 (3-252) 11.8 (9-72) 16.9 (7-154) 14.1 (3-252) 14.1 (3-252)
DLBCL subtype, n (%)
 Non-GCB 2 (29) 5 (42) 8 (89) 5 (56) 3 (37) 13 (61) 23 (51)
 GCB 3 (42) 5 (42) 1 (11) 3 (33) 5 (63) 6 (29) 17 (38)
 Not reported/missing 2 (29) 2 (16) 0 (0) 1 (11) 0 (0) 2 (10) 5 (11)
DLBCL category, n (%)
 De novo 5 (71) 8 (67) 7 (78) 6 (67) 4 (50) 15 (71) 30 (67)
 Transformed 2 (29) 4 (33) 2 (22) 3 (33) 4 (50) 6 (29) 15 (33)
Ann Arbor staging, n (%)
 II/IIE 3 (42) 1 (8) 1 (11) 1 (11) 0 (0) 2 (9) 6 (13)
 III/IIIE/IIIE,S 2 (29) 1 (8) 0 (0) 2 (22) 3 (37) 1 (5) 8 (18)
 IV 2 (29) 10 (84) 8 (89) 6 (67) 5 (63) 18 (86) 31 (69)
Bulky disease, n (%) 6 (86) 5 (42) 3 (33) 5 (56) 5 (63) 8 (38) 24 (53)
 5-10 cm 4 (57) 2 (17) 2 (22) 3 (33) 5 (63) 4 (19) 16 (36)
 >10 cm 2 (29) 3 (25) 1 (11) 2 (22) 0 (0) 4 (19) 8 (18)
No. of prior regimens, n (%)
 1 0 (0) 2 (17) 2 (22) 2 (22) 1 (13) 4 (19) 7 (16)
 ≥2 7 (100) 10 (83) 7 (78) 7 (78) 7 (88) 17 (81) 38 (84)
Disease status at completion of treatment regimen preceding study entry, n (%)
 Refractory 4 (57) 8 (67) 5 (56) 5 (56) 5 (63) 13 (62) 27 (60)
 Relapsed 3 (43) 4 (33) 4 (44) 4 (44) 3 (38) 8 (38) 18 (40)
  CR 1 (14) 3 (25) 4 (44) 4 (44) 3 (38) 7 (33) 15 (33)
  PR 2 (29) 1 (8) 0 (0) 0 (0) 0 (0) 1 (5) 3 (7)
Primary refractory disease, n (%) 5 (71) 3 (25) 2 (22) 1 (11) 1 (13) 5 (24) 12 (27)
Prior autologous transplant§ 2 (29) 3 (25) 4 (44) 0 (0) 2 (25) 7 (33) 11 (24)
Median time from last dose of prior therapy to first ibrutinib dose, mo (range) 1.9 (1.1-20.7) 2.2 (0.7-20.6) 2.4 (0.7-36.6) 2.5 (2.1-68.3) 2.7 (0.0-65.7) 2.4 (0.7-36.6) 2.4 (0.0-68.3)

BMI, body mass index; ECOG PS, Eastern Cooperative Oncology Group performance status; SD, standard deviation.

*

1 patient in dose level −1 had unknown race.

Based on local pathology laboratory reports.

Defined as stable disease or progressive disease at completion of treatment regimen preceding study entry.

Defined as refractory to front-line regimen (only received 1 prior therapy) based on medical history.

§

Two patients with prior autologous transplant did not respond to salvage therapy.