Table III.
Toxicity | B1 Cohort (weekly × 4) (n=54) |
B2 Cohort (twice weekly × 8) (n=60) |
B1 and B2 Cohorts (n=114) |
AALL01P2* (n=63) |
P-value** |
---|---|---|---|---|---|
Infection (documented clinically or microbiologically) | 35 (64.8%) | 22 (36.7%) | 57 (50.0%) | 21 (33.3%) | 0.0233 |
Febrile neutropenia | 9 (16.7%) | 21 (35%) | 30 (26.3%) | 28 (44.4%) | 0.0114 |
Hyperglycemia | 17 (31.5) | 11(18.3%) | 28 (24.6%) | 7 (11.1%) | 0.0227 |
ALT elevation | 4 (7.4%) | 7 (11.7%) | 11 (9.6%) | 12 (19.0%) | 0.0629 |
Pancreatitis | 6 (11.1%) | 1 (1.7%) | 7 (6.1%) | 4 (6.3%) | 0.5953 |
Analysis limited to the 63 patients on AALL01P2 with early marrow B-lineage relapses;
One-sided P-values are provided for comparisons of toxicites in the B1 and B2 cohorts combined vs. AALL01P2.