Authors
Vilmarie Rodriguez, John Kairalla, Wanda L Salzer, Elizabeth A Raetz, Mignon LC Loh, Andrew J Carroll, Nyla A Heerema, Brent L Wood, Michael J Borowitz, Michael J Burke, Barbara L Asselin, Meenakshi Devidas, Naomi J Winick, William L Carroll, Stephen P Hunger, ZoAnn E Dreyer
Publication date
2016/8/1
Journal
Journal of pediatric hematology/oncology
Volume
38
Issue
6
Pages
409-417
Publisher
LWW
Description
AALL08P1 was designed to determine whether biweekly intensified pegaspargase (I-PEG) was feasible and safe in pediatric patients with newly diagnosed high-risk B-precursor lymphoblastic leukemia when given with Children’s Oncology Group hemiaugmented BFM therapy. High-risk average (HR-Avg) patients received standard pegaspargase dosing (6 doses), whereas high-risk high (HR-High) patients received I-PEG biweekly from the start of Consolidation until day 1 of Maintenance. Feasibility and safety were defined in advance as≥ 65% of patients tolerating at least 8 doses of I-PEG and 90% requiring≤ 49 weeks from day 1 of Consolidation to the initiation of Maintenance. Targeted toxicities included allergic reactions, anaphylaxis, pancreatitis, thrombosis, bleeding, central nervous system events, and sepsis. AALL08P1 enrolled 104 patients; 54 were classified as HR-Avg and 30 as HR-High after …
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