Patient demographics and baseline characteristics
| . | Daily VEN administration . | VEN administration for 10 d per 21-d cycle . | ||||
|---|---|---|---|---|---|---|
| Characteristic, n (%) . | VEN 200 mg, . | VEN 400 mg, . | VEN 600 mg, . | VEN 800 mg, . | . | |
| Cohort 1 (n = 7) . | Cohort 2 (n = 3) . | Cohort 3 (n = 8) . | Cohort 4 (n = 6) . | Total (N = 24) . | ||
| Arm A: VEN + R-CHOP | ||||||
| Mean age, y (range) | 67.0 (57-79) | 61.0 (52-76) | 57.0 (37-70) | 56.3 (44-77) | 60.3 (37-79) | |
| Sex | ||||||
| Male | 4 (57.1) | 1 (33.3) | 6 (75.0) | 4 (66.7) | 15 (62.5) | |
| Female | 3 (42.9) | 2 (66.7) | 2 (25.0) | 2 (33.3) | 9 (37.5) | |
| ECOG performance status | ||||||
| 0-1 | 7 (100) | 3 (100) | 7 (87.5) | 6 (100) | 23 (95.8) | |
| 2 | 0 | 0 | 1 (12.5) | 0 | 1 (4.2) | |
| BM involvement | ||||||
| Yes | 1 (14.3) | 1 (33.3) | 3 (37.5) | 1 (16.7) | 6 (25.0) | |
| No | 6 (85.7) | 1 (33.3) | 4 (50.0) | 4 (66.7) | 15 (62.5) | |
| Unknown | 0 | 1 (33.3) | 1 (12.5) | 1 (16.7) | 3 (12.5) | |
| Histology | ||||||
| DLBCL | 3 (42.9) | 0 | 2 (25.0) | 5 (83.3) | 10 (41.7) | |
| FL | 3 (42.9) | 1 (33.3) | 6 (75.0) | 0 | 10 (41.7) | |
| Other* | 1 (14.3) | 2 (66.7) | 0 | 1 (16.7) | 4 (16.7) | |
| Number of patients with prior therapies† | 1 | 0 | 1 | 0 | 2 | |
| Number of patients with bulky disease (cutoff 10 cm) | 0 | 0 | 1 | 0 | 1 | |
| Number of patients with lymphocytosis | 0 | 0 | 1 | 1 | 2 | |
| . | Daily VEN administration . | VEN administration for 10 d per 21-d cycle . | ||||
|---|---|---|---|---|---|---|
| Characteristic, n (%) . | VEN 200 mg, . | VEN 400 mg, . | VEN 600 mg, . | VEN 800 mg, . | . | |
| Cohort 1 (n = 7) . | Cohort 2 (n = 3) . | Cohort 3 (n = 8) . | Cohort 4 (n = 6) . | Total (N = 24) . | ||
| Arm A: VEN + R-CHOP | ||||||
| Mean age, y (range) | 67.0 (57-79) | 61.0 (52-76) | 57.0 (37-70) | 56.3 (44-77) | 60.3 (37-79) | |
| Sex | ||||||
| Male | 4 (57.1) | 1 (33.3) | 6 (75.0) | 4 (66.7) | 15 (62.5) | |
| Female | 3 (42.9) | 2 (66.7) | 2 (25.0) | 2 (33.3) | 9 (37.5) | |
| ECOG performance status | ||||||
| 0-1 | 7 (100) | 3 (100) | 7 (87.5) | 6 (100) | 23 (95.8) | |
| 2 | 0 | 0 | 1 (12.5) | 0 | 1 (4.2) | |
| BM involvement | ||||||
| Yes | 1 (14.3) | 1 (33.3) | 3 (37.5) | 1 (16.7) | 6 (25.0) | |
| No | 6 (85.7) | 1 (33.3) | 4 (50.0) | 4 (66.7) | 15 (62.5) | |
| Unknown | 0 | 1 (33.3) | 1 (12.5) | 1 (16.7) | 3 (12.5) | |
| Histology | ||||||
| DLBCL | 3 (42.9) | 0 | 2 (25.0) | 5 (83.3) | 10 (41.7) | |
| FL | 3 (42.9) | 1 (33.3) | 6 (75.0) | 0 | 10 (41.7) | |
| Other* | 1 (14.3) | 2 (66.7) | 0 | 1 (16.7) | 4 (16.7) | |
| Number of patients with prior therapies† | 1 | 0 | 1 | 0 | 2 | |
| Number of patients with bulky disease (cutoff 10 cm) | 0 | 0 | 1 | 0 | 1 | |
| Number of patients with lymphocytosis | 0 | 0 | 1 | 1 | 2 | |
| . | Daily VEN administration . | VEN administration for 10 d per 21-d cycle/5 d for Cohort 4B . | ||||
|---|---|---|---|---|---|---|
| Characteristic, n (%) . | VEN 200 mg, . | VEN 400 mg, . | VEN 600 mg, . | VEN 800 mg, . | VEN 800 mg, . | . |
| Cohort 1 (n = 7) . | Cohort 2 (n = 7) . | Cohort 3 (n = 6) . | Cohort 4A (n = 6) . | Cohort 4B (n = 6) . | Total (N = 32) . | |
| Arm B: VEN + G-CHOP | ||||||
| Mean age, y (range) | 52.1 (24-69) | 60.9 (55-73) | 66.7 (61-71) | 60.5 (39-76) | 66.8 (58-74) | 61.1 (24-76) |
| Sex | ||||||
| Male | 5 (71.4) | 2 (28.6) | 2 (33.3) | 2 (33.3) | 4 (66.7) | 15 (46.9) |
| Female | 2 (28.6) | 5 (71.4) | 4 (66.7) | 4 (66.7) | 2 (33.3) | 17 (53.1) |
| ECOG performance status | ||||||
| 0-1 | 7 (100) | 7 (100) | 6 (100) | 6 (100) | 5 (83.3) | 31 (96.9) |
| 2 | 0 | 0 | 0 | 0 | 1 (16.7) | 1 (3.1) |
| Number of patients with prior therapies† | 1 | 0 | 1 | 1 | 0 | 3 |
| Number of patients with bulky disease (cutoff 10 cm) | 0 | 1 | 1 | 0 | 0 | 2 |
| Number of patients with lymphocytosis | 2 | 1 | 0 | 1 | 0 | 4 |
| BM involvement | ||||||
| Yes | 2 (28.6) | 2 (28.6) | 3 (50.0) | 3 (50.0) | 2 (33.3) | 12 (37.5) |
| No | 5 (74.1) | 4 (57.1) | 3 (50.0) | 3 (50.0) | 4 (66.7) | 19 (59.4) |
| Unknown | 0 | 1 (14.3) | 0 | 0 | 0 | 1 (3.1) |
| Histology | ||||||
| DLBCL | 0 | 1 (14.3) | 2 (33.3) | 2 (33.3) | 3 (50.0) | 8 (25.0) |
| FL | 3 (42.9) | 3 (42.9) | 3 (50.0) | 3 (50.0) | 2 (33.3) | 14 (43.8) |
| Other* | 4 (57.1) | 3 (42.9) | 1 (16.7) | 1 (16.7) | 1 (16.7) | 10 (31.3) |
| . | Daily VEN administration . | VEN administration for 10 d per 21-d cycle/5 d for Cohort 4B . | ||||
|---|---|---|---|---|---|---|
| Characteristic, n (%) . | VEN 200 mg, . | VEN 400 mg, . | VEN 600 mg, . | VEN 800 mg, . | VEN 800 mg, . | . |
| Cohort 1 (n = 7) . | Cohort 2 (n = 7) . | Cohort 3 (n = 6) . | Cohort 4A (n = 6) . | Cohort 4B (n = 6) . | Total (N = 32) . | |
| Arm B: VEN + G-CHOP | ||||||
| Mean age, y (range) | 52.1 (24-69) | 60.9 (55-73) | 66.7 (61-71) | 60.5 (39-76) | 66.8 (58-74) | 61.1 (24-76) |
| Sex | ||||||
| Male | 5 (71.4) | 2 (28.6) | 2 (33.3) | 2 (33.3) | 4 (66.7) | 15 (46.9) |
| Female | 2 (28.6) | 5 (71.4) | 4 (66.7) | 4 (66.7) | 2 (33.3) | 17 (53.1) |
| ECOG performance status | ||||||
| 0-1 | 7 (100) | 7 (100) | 6 (100) | 6 (100) | 5 (83.3) | 31 (96.9) |
| 2 | 0 | 0 | 0 | 0 | 1 (16.7) | 1 (3.1) |
| Number of patients with prior therapies† | 1 | 0 | 1 | 1 | 0 | 3 |
| Number of patients with bulky disease (cutoff 10 cm) | 0 | 1 | 1 | 0 | 0 | 2 |
| Number of patients with lymphocytosis | 2 | 1 | 0 | 1 | 0 | 4 |
| BM involvement | ||||||
| Yes | 2 (28.6) | 2 (28.6) | 3 (50.0) | 3 (50.0) | 2 (33.3) | 12 (37.5) |
| No | 5 (74.1) | 4 (57.1) | 3 (50.0) | 3 (50.0) | 4 (66.7) | 19 (59.4) |
| Unknown | 0 | 1 (14.3) | 0 | 0 | 0 | 1 (3.1) |
| Histology | ||||||
| DLBCL | 0 | 1 (14.3) | 2 (33.3) | 2 (33.3) | 3 (50.0) | 8 (25.0) |
| FL | 3 (42.9) | 3 (42.9) | 3 (50.0) | 3 (50.0) | 2 (33.3) | 14 (43.8) |
| Other* | 4 (57.1) | 3 (42.9) | 1 (16.7) | 1 (16.7) | 1 (16.7) | 10 (31.3) |
VEN, venetoclax.
Transformed lymphoma, marginal zone lymphoma, composite lymphoma, and Waldenström macroglobulinemia. Given the mixed population of NHL patients enrolled in the study, risk categories for the International Prognostic Index (DLBCL patients) and Follicular Lymphoma International Prognostic Index (FL patients) were not collected on the case report form.
One patient with FL received 2 prior therapies (1L rituximab and then second-line cyclophosphamide, vincristine, and prednisone followed by rituximab maintenance); however, this was considered a protocol violation. Four (7%) additional patients received 1 prior therapy, including 1 patient with FL who received rituximab, 2 patients with FL who received radiotherapy, and 1 patient with marginal zone lymphoma who received rituximab, cyclophosphamide, vincristine, and prednisone.