ArticleHemaSphere2023
Incidence and Characteristics of Hypersensitivity Reactions to PEG-asparaginase Observed in 6136 Children With Acute Lymphoblastic Leukemia Enrolled in the AIEOP-BFM ALL 2009 Study Protocol.
Article in HemaSphere, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.
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Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.
- PEG-asparaginase treatment regimens for acute lymphoblastic leukaemia in children: a network meta-analysis.The Cochrane database of systematic reviews · 2023Pooled it
- Identification of favorable subgroups of pediatric high-hyperdiploid acute lymphoblastic leukemia-A retrospective multinational study.HemaSphere · 2026Article
- Molecular variants, clonal evolution and clinical relevance in pediatric and adult T-cell lymphoblastic neoplasia.Blood cancer journal · 2026Article
- Article
- Blinatumomab restores asparaginase activity in pediatric B-cell acute lymphoblastic leukemia patients with PEGasparaginase hypersensitivity.Haematologica · 2026Article
- PEGylated Asparaginase in Children with Acute Lymphoblastic Leukemia Treated within the AIEOP-BFM ALL 2009 Trial: Population Pharmacokinetics and Drug Exposure.European journal of drug metabolism and pharmacokinetics · 2025Article
- Results in pediatric T-ALL patients treated in trial AIEOP-BFM ALL 2009: Prognostic factors in the context of modern risk-adapted therapy.HemaSphere · 2025Article
- Pharmacokinetics of Pegaspargase with a Limited Sampling Strategy for Asparaginase Activity Monitoring in Children with Acute Lymphoblastic Leukemia.Pharmaceutics · 2025Article
- Pharmacokinetics of PEGasparaginase in Infants with Acute Lymphoblastic Leukemia.Pharmaceutical research · 2024Article
- Back to the future: the amazing journey of the therapeutic anti-leukemia enzyme asparaginaseHaematologica · 2023Article
- Hypersensitivity Reactions to NativeHemaSphere · 2023Article
- Current Use of Asparaginase in Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma.Frontiers in pediatrics · 2022Review
Corrections and comments
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Authors and funding
19 authors at 11 institutions in 7 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The incidence of hypersensitivity reactions (HSRs) to PEG-asparaginase (PEG-ASNase) was evaluated in 6136 children with ALL enrolled in the AIEOP-BFM ALL 2009 study. Patients with B-cell precursor-acute lymphoblastic leukemia (BCP-ALL) were stratified as standard-risk/medium-risk (MR)/high-risk (HR) and those with T-ALL as non-High/HR. PEG-ASNase was administered intravenously at 2500 IU/sqm/dose. All patients received 2 PEG-ASNase doses in induction; thereafter non-HR versus HR patients received 1 versus 6 PEG-ASNase doses, respectively. After the single regular dose of PEG-ASNase at the beginning of delayed intensification, BCP-ALL-MR patients were randomized to receive 9 additional PEG-ASNase doses every 2 weeks (experimental arm [EA]) versus none (standard arm [SA]); HR patients were randomized to receive, in consolidation, 4 weekly PEG-ASNase doses (EA) versus none (SA). The HSR cumulative incidence (CI) was estimated adjusting for competing risks. An HSR occurred in 472 of 6136 (7.7%) patients. T-non- HR/BCP-Standard-Risk, BCP-MR-SA, BCP-MR-EA, HR-SA and HR-EA patients had 1-year-CI-HSR (±SE) rates of 5.2% (0.5), 5.2% (0.5), 4.0% (0.8), 20.2% (1.2), and 6.4% (1.3), respectively. The randomized intensification of PEG-ASNase did not significantly impact on HSR incidence in BCP-MR patients (1-y-CI-HSR 3.8% [0.8] versus 3.2% [0.6] in MR-EA versus MR-SA;
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.