A pilot study of intensified PEG-asparaginase in high-risk acute lymphoblastic leukemia: Children's oncology group study AALL08P1

Vilmarie Rodriguez, John Kairalla, Wanda L. Salzer, Elizabeth A. Raetz, Mignon L C 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, Zo Ann E Dreyer

Research output: Contribution to journalArticle

4 Scopus citations

Abstract

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 HRHigh after completion of induction therapy. Only 53% (16/30) of the HR-High patients received ≥8 total doses of I-PEG and 50% (15/30) took ≤49 weeks from start of Consolidation to the initiation of Maintenance. I-PEG did not significantly increase grade 2 to 5 targeted toxicities. I-PEG was not feasible or safe as defined in AALL08P1. Complete assessment of this regimen was limited due to removal of patients from I-PEG regimen and early closure of the study.

Original languageEnglish (US)
Pages (from-to)409-412
Number of pages4
JournalJournal of Pediatric Hematology/Oncology
Volume38
Issue number6
DOIs
StatePublished - Jul 26 2016

Keywords

  • Acute lymphoblastic leukemia
  • High risk
  • Intensified asparaginase
  • Toxicities

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Hematology
  • Oncology

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    Rodriguez, V., Kairalla, J., Salzer, W. L., Raetz, E. A., Loh, M. L. C., Carroll, A. J., Heerema, N. A., Wood, B. L., Borowitz, M. J., Burke, M. J., Asselin, B. L., Devidas, M., Winick, N. J., Carroll, W. L., Hunger, S. P., & Dreyer, Z. A. E. (2016). A pilot study of intensified PEG-asparaginase in high-risk acute lymphoblastic leukemia: Children's oncology group study AALL08P1. Journal of Pediatric Hematology/Oncology, 38(6), 409-412. https://doi.org/10.1097/MPH.0000000000000589