Demographic and baseline characteristics (safety analysis population)
| . | IM 25 mg/m2 MWF (n = 33) . | IM 37.5 mg/m2 MWF (n = 83) . | IM 25/25/50 mg/m2 MWF (n = 51) . | IM total (n = 167) . | IV 25/25/50 mg/m2 MWF (n = 61) . |
|---|---|---|---|---|---|
| Median (range) age, y | 11 (1-24) | 8 (1-20) | 12 (3-25) | 10 (1-25) | 10 (1-24) |
| <6 | 9 (27) | 24 (29) | 11 (22) | 44 (26) | 20 (33) |
| ≥6 to <12 | 9 (27) | 34 (41) | 14 (27) | 57 (34) | 14 (23) |
| ≥12 to <18 | 7 (21) | 20 (24) | 18 (35) | 45 (27) | 17 (28) |
| ≥18 | 8 (24) | 5 (6) | 8 (16) | 21 (13) | 10 (16) |
| Sex | |||||
| Female | 16 (48) | 28 (34) | 20 (39) | 64 (38) | 25 (41) |
| Male | 17 (52) | 55 (66) | 31 (61) | 103 (62) | 36 (59) |
| Ethnicity∗ | |||||
| Hispanic or Latino | 13 (39) | 23 (28) | 17 (33) | 53 (32) | 21 (34) |
| Not Hispanic or Latino | 18 (55) | 56 (67) | 32 (63) | 106 (63) | 34 (56) |
| Not reported | 2 (6) | 4 (5) | 2 (4) | 8 (5) | 6 (10) |
| Race∗ | |||||
| American Indian or Alaska Native | 0 | 0 | 3 (6) | 3 (2) | 2 (3) |
| Asian | 1 (3) | 5 (6) | 1 (2) | 7 (4) | 3 (5) |
| Black or African American | 3 (9) | 11 (13) | 8 (16) | 22 (13) | 2 (3) |
| White | 24 (73) | 58 (70) | 33 (65) | 115 (69) | 43 (70) |
| Multiple | 1 (3) | 0 | 0 | 1 (1) | 1 (2) |
| Not reported | 4 (12) | 9 (11) | 6 (12) | 19 (11) | 10 (16) |
| Median (range) BMI, kg/m2 | 19.9 (13.4-42.6) | 17.9 (13.7-30.7)† | 18.4 (13.8-42.0) | 18.4 (13.4-42.6)‡ | 19.6 (13.2-43.8) |
| Median (range) BSA, m2 | 1.3 (0.4-2.5) | 1.0 (0.6-2.3)† | 1.3 (0.5-2.4) | 1.2 (0.4-2.5)‡ | 1.2 (0.5-2.4) |
| Primary disease | |||||
| ALL | |||||
| B-ALL | 27 (82) | 60 (72) | 37 (73) | 124 (74) | 51 (84) |
| T-ALL | 4 (12) | 13 (16) | 9 (18) | 26 (16) | 7 (11) |
| LBL | |||||
| B-LBL | 0 | 0 | 1 (2) | 1 (1) | 2 (3) |
| T-LBL | 2 (6) | 10 (12) | 4 (8) | 16 (10) | 1 (2) |
| Eligibility criteria met | |||||
| Grade ≥3 allergic reaction to an E coli–derived asparaginase§ | 27 (82) | 75 (90) | 44 (86) | 146 (87) | 44 (72) |
| Silent inactivation‖ | 3 (9) | 3 (4) | 1 (2) | 7 (4) | 8 (13) |
| Allergic reaction with inactivation | 3 (9) | 5 (6) | 6 (12) | 14 (8) | 9 (15) |
| . | IM 25 mg/m2 MWF (n = 33) . | IM 37.5 mg/m2 MWF (n = 83) . | IM 25/25/50 mg/m2 MWF (n = 51) . | IM total (n = 167) . | IV 25/25/50 mg/m2 MWF (n = 61) . |
|---|---|---|---|---|---|
| Median (range) age, y | 11 (1-24) | 8 (1-20) | 12 (3-25) | 10 (1-25) | 10 (1-24) |
| <6 | 9 (27) | 24 (29) | 11 (22) | 44 (26) | 20 (33) |
| ≥6 to <12 | 9 (27) | 34 (41) | 14 (27) | 57 (34) | 14 (23) |
| ≥12 to <18 | 7 (21) | 20 (24) | 18 (35) | 45 (27) | 17 (28) |
| ≥18 | 8 (24) | 5 (6) | 8 (16) | 21 (13) | 10 (16) |
| Sex | |||||
| Female | 16 (48) | 28 (34) | 20 (39) | 64 (38) | 25 (41) |
| Male | 17 (52) | 55 (66) | 31 (61) | 103 (62) | 36 (59) |
| Ethnicity∗ | |||||
| Hispanic or Latino | 13 (39) | 23 (28) | 17 (33) | 53 (32) | 21 (34) |
| Not Hispanic or Latino | 18 (55) | 56 (67) | 32 (63) | 106 (63) | 34 (56) |
| Not reported | 2 (6) | 4 (5) | 2 (4) | 8 (5) | 6 (10) |
| Race∗ | |||||
| American Indian or Alaska Native | 0 | 0 | 3 (6) | 3 (2) | 2 (3) |
| Asian | 1 (3) | 5 (6) | 1 (2) | 7 (4) | 3 (5) |
| Black or African American | 3 (9) | 11 (13) | 8 (16) | 22 (13) | 2 (3) |
| White | 24 (73) | 58 (70) | 33 (65) | 115 (69) | 43 (70) |
| Multiple | 1 (3) | 0 | 0 | 1 (1) | 1 (2) |
| Not reported | 4 (12) | 9 (11) | 6 (12) | 19 (11) | 10 (16) |
| Median (range) BMI, kg/m2 | 19.9 (13.4-42.6) | 17.9 (13.7-30.7)† | 18.4 (13.8-42.0) | 18.4 (13.4-42.6)‡ | 19.6 (13.2-43.8) |
| Median (range) BSA, m2 | 1.3 (0.4-2.5) | 1.0 (0.6-2.3)† | 1.3 (0.5-2.4) | 1.2 (0.4-2.5)‡ | 1.2 (0.5-2.4) |
| Primary disease | |||||
| ALL | |||||
| B-ALL | 27 (82) | 60 (72) | 37 (73) | 124 (74) | 51 (84) |
| T-ALL | 4 (12) | 13 (16) | 9 (18) | 26 (16) | 7 (11) |
| LBL | |||||
| B-LBL | 0 | 0 | 1 (2) | 1 (1) | 2 (3) |
| T-LBL | 2 (6) | 10 (12) | 4 (8) | 16 (10) | 1 (2) |
| Eligibility criteria met | |||||
| Grade ≥3 allergic reaction to an E coli–derived asparaginase§ | 27 (82) | 75 (90) | 44 (86) | 146 (87) | 44 (72) |
| Silent inactivation‖ | 3 (9) | 3 (4) | 1 (2) | 7 (4) | 8 (13) |
| Allergic reaction with inactivation | 3 (9) | 5 (6) | 6 (12) | 14 (8) | 9 (15) |
Data are n (%) unless stated otherwise. Patients received various ALL/LBL treatment protocols, including (but not limited to) Children’s Oncology Group AALL0232, AALL0434, AALL0932, AALL1131, AALL1231, AALL1631, AALL1731, and AALL1732, as well as DFC16-001 and TOT17. The prior pegylated asparaginase doses received ranged from 1-6 in this study.
B-ALL, B-cell ALL; B-LBL, B-cell LBL; BMI, body mass index; T-ALL, T-cell ALL; T-LBL, T-cell LBL.
Self-reported.
Based on 82 patients.
Based on 166 patients.
Prior long-acting E coli–derived asparaginase treatment was pegaspargase for all patients apart from 1 who received another type of E coli–derived asparaginase.
Silent inactivation was defined as NSAA of <0.5 IU/mL within 1 hour to 1 day, or <0.3 IU/mL within 7 days, or <0.1 IU/mL within 14 days of completing a long-acting E coli–derived asparaginase infusion without clinical signs/symptoms of hypersensitivity or allergy.