TEAEs for B-cell ALL and T-cell ALL/LL cohorts
| n (%) . | Childhood B-cell ALL (n = 7) . | Childhood T-cell ALL (n = 24) . | Young adult T-cell ALL (n = 5) . | T-cell LL (n = 10) . |
|---|---|---|---|---|
| Any-grade TEAE | 7 (100) | 24 (100) | 5 (100) | 10 (100) |
| Any-grade TEAEs in >50% of patients in any cohort | ||||
| Febrile neutropenia | 5 (71.4) | 12 (50.0) | 3 (60.0) | 6 (60.0) |
| Anemia | 4 (57.1) | 16 (66.7) | 2 (40.0) | 10 (100) |
| Thrombocytopenia | 2 (28.6) | 18 (75.0) | 3 (60.0) | 9 (90.0) |
| Neutropenia | 2 (28.6) | 15 (62.5) | 2 (40.0) | 6 (60.0) |
| Leukopenia | 3 (42.9) | 9 (37.5) | 1 (20.0) | 5 (50.0) |
| Vomiting | 2 (28.6) | 15 (62.5) | 2 (40.0) | 5 (50.0) |
| Abdominal pain | 2 (28.6) | 12 (50.0) | 3 (60.0) | 4 (40.0) |
| Stomatitis | 0 | 11 (45.8) | 3 (60.0) | 7 (70.0) |
| Constipation | 2 (28.6) | 6 (25.0) | 4 (80.0) | 2 (20.0) |
| Pyrexia | 4 (57.1) | 17 (70.8) | 3 (60.0) | 8 (80.0) |
| Fatigue | 0 | 3 (12.5) | 3 (60.0) | 1 (10.0) |
| Hyperbilirubinemia | 0 | 8 (33.3) | 4 (80.0) | 4 (40.0) |
| ALT increased | 3 (42.9) | 10 (41.7) | 3 (60.0) | 5 (50.0) |
| AST increased | 2 (28.6) | 5 (20.8) | 3 (60.0) | 5 (50.0) |
| Blood AP increased | 0 | 0 | 4 (80.0) | 0 |
| Hypoalbuminemia | 0 | 12 (50.0) | 3 (60.0) | 5 (50.0) |
| Hyponatremia | 0 | 6 (25.0) | 4 (80.0) | 2 (20.0) |
| Cough | 3 (42.9) | 7 (29.2) | 0 | 5 (50.0) |
| Hypoxia | 2 (28.6) | 4 (16.7) | 3 (60.0) | 0 |
| Grade 3/4 TEAE | 7 (100) | 24 (100) | 5 (100) | 10 (100) |
| Grade 3/4 TEAEs in >40% of patients in any cohort | ||||
| Febrile neutropenia | 5 (71.4) | 12 (50.0) | 3 (60.0) | 5 (50.0) |
| Anemia | 3 (42.9) | 16 (66.7) | 1 (20.0) | 10 (100) |
| Leukopenia | 3 (42.9) | 9 (37.5) | 1 (20.0) | 5 (50.0) |
| Neutropenia | 2 (28.6) | 15 (62.5) | 2 (40.0) | 6 (60.0) |
| Thrombocytopenia | 1 (14.3) | 15 (62.5) | 3 (60.0) | 9 (90.0) |
| Serious TEAE | 3 (42.9) | 16 (66.7) | 4 (80.0) | 7 (70.0) |
| TEAE leading to daratumumab discontinuation | 0 | 1 (4.2) | 2 (40.0) | 1 (10.0) |
| Death due to TEAEs | 2 (28.6) | 2 (8.3) | 0 | 1 (10.0) |
| IRRs | ||||
| Grade 1/2 | 4 (57.1) | 15 (62.5) | 4 (80.0) | 7 (70.0) |
| Grade 3 | 0 | 1 (4.2) | 0 | 1 (10.0) |
| n (%) . | Childhood B-cell ALL (n = 7) . | Childhood T-cell ALL (n = 24) . | Young adult T-cell ALL (n = 5) . | T-cell LL (n = 10) . |
|---|---|---|---|---|
| Any-grade TEAE | 7 (100) | 24 (100) | 5 (100) | 10 (100) |
| Any-grade TEAEs in >50% of patients in any cohort | ||||
| Febrile neutropenia | 5 (71.4) | 12 (50.0) | 3 (60.0) | 6 (60.0) |
| Anemia | 4 (57.1) | 16 (66.7) | 2 (40.0) | 10 (100) |
| Thrombocytopenia | 2 (28.6) | 18 (75.0) | 3 (60.0) | 9 (90.0) |
| Neutropenia | 2 (28.6) | 15 (62.5) | 2 (40.0) | 6 (60.0) |
| Leukopenia | 3 (42.9) | 9 (37.5) | 1 (20.0) | 5 (50.0) |
| Vomiting | 2 (28.6) | 15 (62.5) | 2 (40.0) | 5 (50.0) |
| Abdominal pain | 2 (28.6) | 12 (50.0) | 3 (60.0) | 4 (40.0) |
| Stomatitis | 0 | 11 (45.8) | 3 (60.0) | 7 (70.0) |
| Constipation | 2 (28.6) | 6 (25.0) | 4 (80.0) | 2 (20.0) |
| Pyrexia | 4 (57.1) | 17 (70.8) | 3 (60.0) | 8 (80.0) |
| Fatigue | 0 | 3 (12.5) | 3 (60.0) | 1 (10.0) |
| Hyperbilirubinemia | 0 | 8 (33.3) | 4 (80.0) | 4 (40.0) |
| ALT increased | 3 (42.9) | 10 (41.7) | 3 (60.0) | 5 (50.0) |
| AST increased | 2 (28.6) | 5 (20.8) | 3 (60.0) | 5 (50.0) |
| Blood AP increased | 0 | 0 | 4 (80.0) | 0 |
| Hypoalbuminemia | 0 | 12 (50.0) | 3 (60.0) | 5 (50.0) |
| Hyponatremia | 0 | 6 (25.0) | 4 (80.0) | 2 (20.0) |
| Cough | 3 (42.9) | 7 (29.2) | 0 | 5 (50.0) |
| Hypoxia | 2 (28.6) | 4 (16.7) | 3 (60.0) | 0 |
| Grade 3/4 TEAE | 7 (100) | 24 (100) | 5 (100) | 10 (100) |
| Grade 3/4 TEAEs in >40% of patients in any cohort | ||||
| Febrile neutropenia | 5 (71.4) | 12 (50.0) | 3 (60.0) | 5 (50.0) |
| Anemia | 3 (42.9) | 16 (66.7) | 1 (20.0) | 10 (100) |
| Leukopenia | 3 (42.9) | 9 (37.5) | 1 (20.0) | 5 (50.0) |
| Neutropenia | 2 (28.6) | 15 (62.5) | 2 (40.0) | 6 (60.0) |
| Thrombocytopenia | 1 (14.3) | 15 (62.5) | 3 (60.0) | 9 (90.0) |
| Serious TEAE | 3 (42.9) | 16 (66.7) | 4 (80.0) | 7 (70.0) |
| TEAE leading to daratumumab discontinuation | 0 | 1 (4.2) | 2 (40.0) | 1 (10.0) |
| Death due to TEAEs | 2 (28.6) | 2 (8.3) | 0 | 1 (10.0) |
| IRRs | ||||
| Grade 1/2 | 4 (57.1) | 15 (62.5) | 4 (80.0) | 7 (70.0) |
| Grade 3 | 0 | 1 (4.2) | 0 | 1 (10.0) |
ALT, alanine aminotransferase; AST, aspartate aminotransferase; AP, alkaline phosphatase.