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

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 HR-High 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)
JournalJournal of Pediatric Hematology/Oncology
DOIs
StateAccepted/In press - Jun 13 2016

Fingerprint

Precursor Cell Lymphoblastic Leukemia-Lymphoma
Maintenance
pegaspargase
Anaphylaxis
Pancreatitis
Sepsis
Hypersensitivity
Thrombosis
Central Nervous System
Pediatrics
Hemorrhage
Safety
Therapeutics

ASJC Scopus subject areas

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

Cite this

A Pilot Study of Intensified PEG-Asparaginase in High-risk Acute Lymphoblastic Leukemia : Children’s Oncology Group Study AALL08P1. / Rodriguez, Vilmarie; Kairalla, John; Salzer, Wanda L.; Raetz, Elizabeth A.; Loh, Mignon L C; Carroll, Andrew J.; Heerema, Nyla A.; Wood, Brent L.; Borowitz, Michael J; Burke, Michael J.; Asselin, Barbara L.; Devidas, Meenakshi; Winick, Naomi J.; Carroll, William L.; Hunger, Stephen P.; Dreyer, Zo Ann E.

In: Journal of Pediatric Hematology/Oncology, 13.06.2016.

Research output: Contribution to journalArticle

Rodriguez, V, Kairalla, J, Salzer, WL, Raetz, EA, Loh, MLC, Carroll, AJ, Heerema, NA, Wood, BL, Borowitz, MJ, Burke, MJ, Asselin, BL, Devidas, M, Winick, NJ, Carroll, WL, Hunger, SP & Dreyer, ZAE 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. https://doi.org/10.1097/MPH.0000000000000589
Rodriguez, Vilmarie ; Kairalla, John ; Salzer, Wanda L. ; Raetz, Elizabeth A. ; Loh, Mignon L C ; Carroll, Andrew J. ; Heerema, Nyla A. ; Wood, Brent L. ; Borowitz, Michael J ; Burke, Michael J. ; Asselin, Barbara L. ; Devidas, Meenakshi ; Winick, Naomi J. ; Carroll, William L. ; Hunger, Stephen P. ; Dreyer, Zo Ann E. / A Pilot Study of Intensified PEG-Asparaginase in High-risk Acute Lymphoblastic Leukemia : Children’s Oncology Group Study AALL08P1. In: Journal of Pediatric Hematology/Oncology. 2016.
@article{dfa0c4801dd2462bab395dcc4a0e5b7b,
title = "A Pilot Study of Intensified PEG-Asparaginase in High-risk Acute Lymphoblastic Leukemia: Children’s Oncology Group Study AALL08P1",
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 HR-High 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.",
author = "Vilmarie Rodriguez and John Kairalla and Salzer, {Wanda L.} and Raetz, {Elizabeth A.} and Loh, {Mignon L C} and Carroll, {Andrew J.} and Heerema, {Nyla A.} and Wood, {Brent L.} and Borowitz, {Michael J} and Burke, {Michael J.} and Asselin, {Barbara L.} and Meenakshi Devidas and Winick, {Naomi J.} and Carroll, {William L.} and Hunger, {Stephen P.} and Dreyer, {Zo Ann E}",
year = "2016",
month = "6",
day = "13",
doi = "10.1097/MPH.0000000000000589",
language = "English (US)",
journal = "Journal of Pediatric Hematology/Oncology",
issn = "1077-4114",
publisher = "Lippincott Williams and Wilkins",

}

TY - JOUR

T1 - A Pilot Study of Intensified PEG-Asparaginase in High-risk Acute Lymphoblastic Leukemia

T2 - Children’s Oncology Group Study AALL08P1

AU - Rodriguez, Vilmarie

AU - Kairalla, John

AU - Salzer, Wanda L.

AU - Raetz, Elizabeth A.

AU - Loh, Mignon L C

AU - Carroll, Andrew J.

AU - Heerema, Nyla A.

AU - Wood, Brent L.

AU - Borowitz, Michael J

AU - Burke, Michael J.

AU - Asselin, Barbara L.

AU - Devidas, Meenakshi

AU - Winick, Naomi J.

AU - Carroll, William L.

AU - Hunger, Stephen P.

AU - Dreyer, Zo Ann E

PY - 2016/6/13

Y1 - 2016/6/13

N2 - 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 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.

AB - 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 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.

UR - http://www.scopus.com/inward/record.url?scp=84974724296&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84974724296&partnerID=8YFLogxK

U2 - 10.1097/MPH.0000000000000589

DO - 10.1097/MPH.0000000000000589

M3 - Article

C2 - 27299599

AN - SCOPUS:84974724296

JO - Journal of Pediatric Hematology/Oncology

JF - Journal of Pediatric Hematology/Oncology

SN - 1077-4114

ER -