Demographic and baseline disease characteristics (safety analysis set)
| Characteristic . | Cohort 1a . | Cohort 1b . | Cohort 1c . | Total (N = 167) . |
|---|---|---|---|---|
| 25 mg/m2 MWF (n = 33) . | 37.5 mg/m2 MWF (n = 83) . | 25/25/50 mg/m2 MWF (n = 51) . | ||
| Age, y | ||||
| Median (range) | 11 (1-24) | 8 (1-20) | 12 (3-25) | 10 (1-25) |
| <6, n (%) | 9 (27) | 24 (29) | 11 (22) | 44 (26) |
| 6-<12, n (%) | 9 (27) | 34 (41) | 14 (27) | 57 (34) |
| 12-<18, n (%) | 7 (21) | 20 (24) | 18 (35) | 45 (27) |
| ≥18, n (%) | 8 (24) | 5 (6) | 8 (16) | 21 (13) |
| Sex, n (%) | ||||
| Male | 17 (52) | 55 (66) | 31 (61) | 103 (62) |
| Race, n (%) | ||||
| American Indian or Alaska native | 0 | 0 | 3 (6) | 3 (2) |
| Asian | 1 (3) | 5 (6) | 1 (2) | 7 (4) |
| Black or African American | 3 (9) | 11 (13) | 8 (16) | 22 (13) |
| White | 24 (73) | 58 (70) | 33 (65) | 115 (69) |
| Multiple | 1 (3) | 0 | 0 | 1 (1) |
| Not reported | 4 (12) | 9 (11) | 6 (12) | 19 (11) |
| BMI, median (range), 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) |
| BSA, median (range), m2 | 1.28 (0.44-2.53) | 1.01 (0.56-2.26) | 1.29 (0.54-2.43) | 1.19 (0.44-2.53) |
| Primary disease, n (%) | ||||
| ALL | ||||
| B-ALL | 27 (82) | 60 (72) | 37 (73) | 124 (74) |
| T-ALL | 4 (12) | 13 (16) | 9 (18) | 26 (16) |
| LBL | ||||
| B-LBL | 0 | 0 | 1 (2) | 1 (1) |
| T-LBL | 2 (6) | 10 (12) | 4 (8) | 16 (10) |
| Eligibility criteria met, n (%) | ||||
| Grade ≥3 allergic reaction to an Escherichia coli–derived asparaginase∗ | 27 (82) | 75 (90) | 44 (86) | 146 (87) |
| Silent inactivation | 3 (9) | 3 (4) | 1 (2) | 7 (4) |
| Allergic reaction with inactivation | 3 (9) | 5 (6) | 6 (12) | 14 (8) |
| Characteristic . | Cohort 1a . | Cohort 1b . | Cohort 1c . | Total (N = 167) . |
|---|---|---|---|---|
| 25 mg/m2 MWF (n = 33) . | 37.5 mg/m2 MWF (n = 83) . | 25/25/50 mg/m2 MWF (n = 51) . | ||
| Age, y | ||||
| Median (range) | 11 (1-24) | 8 (1-20) | 12 (3-25) | 10 (1-25) |
| <6, n (%) | 9 (27) | 24 (29) | 11 (22) | 44 (26) |
| 6-<12, n (%) | 9 (27) | 34 (41) | 14 (27) | 57 (34) |
| 12-<18, n (%) | 7 (21) | 20 (24) | 18 (35) | 45 (27) |
| ≥18, n (%) | 8 (24) | 5 (6) | 8 (16) | 21 (13) |
| Sex, n (%) | ||||
| Male | 17 (52) | 55 (66) | 31 (61) | 103 (62) |
| Race, n (%) | ||||
| American Indian or Alaska native | 0 | 0 | 3 (6) | 3 (2) |
| Asian | 1 (3) | 5 (6) | 1 (2) | 7 (4) |
| Black or African American | 3 (9) | 11 (13) | 8 (16) | 22 (13) |
| White | 24 (73) | 58 (70) | 33 (65) | 115 (69) |
| Multiple | 1 (3) | 0 | 0 | 1 (1) |
| Not reported | 4 (12) | 9 (11) | 6 (12) | 19 (11) |
| BMI, median (range), 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) |
| BSA, median (range), m2 | 1.28 (0.44-2.53) | 1.01 (0.56-2.26) | 1.29 (0.54-2.43) | 1.19 (0.44-2.53) |
| Primary disease, n (%) | ||||
| ALL | ||||
| B-ALL | 27 (82) | 60 (72) | 37 (73) | 124 (74) |
| T-ALL | 4 (12) | 13 (16) | 9 (18) | 26 (16) |
| LBL | ||||
| B-LBL | 0 | 0 | 1 (2) | 1 (1) |
| T-LBL | 2 (6) | 10 (12) | 4 (8) | 16 (10) |
| Eligibility criteria met, n (%) | ||||
| Grade ≥3 allergic reaction to an Escherichia coli–derived asparaginase∗ | 27 (82) | 75 (90) | 44 (86) | 146 (87) |
| Silent inactivation | 3 (9) | 3 (4) | 1 (2) | 7 (4) |
| Allergic reaction with inactivation | 3 (9) | 5 (6) | 6 (12) | 14 (8) |
Patients received various ALL/LBL treatment protocols, including (but not limited to) Children’s Oncology Group AALL0434, AALL0932, AALL1131, AALL1231, AALL1731, and AALL1732, as well as DFC16-001 and TOT17.
B-ALL, B-cell ALL; B-LBL, B-cell LBL; BMI, body mass index; BSA, body surface area; T-ALL, T-cell ALL; T-LBL, T-cell LBL.
All patients in part A received pegaspargase before entering the study.