Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2014
Gemtuzumab ozogamicin in children and adolescents with de novo acute myeloid leukemia improves event-free survival by reducing relapse risk: results from the randomized phase III Children’s Oncology Group trial AAML0531.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00372593 (A Phase III Randomized Trial of Gemtuzumab Ozogamicin), which is not on this map. Cited by 286 papers, 7 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase III Randomized Trial of Gemtuzumab Ozogamicin (Mylotarg) Combined With Conventional Chemotherapy for De Novo Acute Myeloid Leukemia (AML) in Children, Adolescents, and Young Adults
Who cites it
286 citing papers in PubMed, 7 syntheses or guidelines pooled it, 461 citations in OpenAlex.
- Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of acute leukemia, version 2.0.Journal for immunotherapy of cancer · 2026Guideline
- Risk of Ophthalmotoxicity Associated with Antibody-Drug Conjugates: A Systematic Review and Meta-analysis.Clinical drug investigation · 2025Pooled it
- Prognostic factors and outcomes in pediatric acute myeloid leukemia: a comprehensive bibliometric analysis of global research trends.Frontiers in oncology · 2025Pooled it
- Response to: meta-analysis on allogeneic transplant for treating pediatric patients with acute myeloid leukemia in first remission: reanalysis of primary data.Annals of hematology · 2023Pooled it
- Meta-analysis on allogeneic transplant for treating pediatric patients with acute myeloid leukemia in first remission: reanalysis of primary data.Annals of hematology · 2023Pooled it
- Allogeneic hematopoietic stem cell transplantation for pediatric acute myeloid leukemia in first complete remission: a meta-analysis.Annals of hematology · 2022Pooled it
- Clinical Benefits and Safety of Gemtuzumab Ozogamicin in Treating Acute Myeloid Leukemia in Various Subgroups: An Updated Systematic Review, Meta-Analysis, and Network Meta-Analysis.Frontiers in immunology · 2021Pooled it
- Improved outcomes of the refined risk-stratification and risk-adapted therapy in children with acute myeloid leukemia: final results of the AIEOP AML 2013.Journal of hematology & oncology · 2026Trial
- Hematopoietic Stem Cell Transplantation Outcomes for High-Risk AML: A Report From the Children's Oncology Group.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025Trial
- Gemtuzumab Ozogamicin Improves Event-Free Survival and Reduces Relapse in PediatricJournal of clinical oncology : official journal of the American Society of Clinical Oncology · 2021Trial
- Trial
- Morphologic remission status is limited compared to ΔN flow cytometry: a Children's Oncology Group AAML0531 report.Blood advances · 2020Trial
- Bortezomib with standard chemotherapy for children with acute myeloid leukemia does not improve treatment outcomes: a report from the Children's Oncology Group.Haematologica · 2020Trial
- Clofarabine Can Replace Anthracyclines and Etoposide in Remission Induction Therapy for Childhood Acute Myeloid Leukemia: The AML08 Multicenter, Randomized Phase III Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2019Trial
- ABCB1 SNP predicts outcome in patients with acute myeloid leukemia treated with Gemtuzumab ozogamicin: a report from Children's Oncology Group AAML0531 Trial.Blood cancer journal · 2019Trial
- Comparable on-therapy mortality and supportive care requirements in Black and White patients following initial induction for pediatric acute myeloid leukemia.Pediatric blood & cancer · 2019Trial
- Outcomes of adolescents and young adults with AML treated on pediatric vs adult protocols.Blood advances · 2026Article
- Article
- Race and Ethnicity and Overall Survival in Pediatric Acute Myeloid Leukemia.JAMA network open · 2026Article
- Article
226 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 9 institutions in 1 country.
Funding
Abstract
purposeTo improve survival rates in children with acute myeloid leukemia (AML), we evaluated gemtuzumab-ozogamicin (GO), a humanized immunoconjugate targeted against CD33, as an alternative to further chemotherapy dose escalation. Our primary objective was to determine whether adding GO to standard chemotherapy improved event-free survival (EFS) and overall survival (OS) in children with newly diagnosed AML. Our secondary objectives examined outcomes by risk group and method of intensification. PATIENTS AND
methodsChildren, adolescents, and young adults ages 0 to 29 years with newly diagnosed AML were enrolled onto Children’s Oncology Group trial AAML0531 and then were randomly assigned to either standard five-course chemotherapy alone or to the same chemotherapy with two doses of GO (3 mg/m2/dose) administered once in induction course 1 and once in intensification course 2 (two of three).
resultsThere were 1,022 evaluable patients enrolled. GO significantly improved EFS (3 years: 53.1% v. 46.9%; hazard ratio [HzR], 0.83; 95% CI, 0.70 to 0.99; P.04) but not OS (3 years: 69.4% v. 65.4%; HzR, 0.91; 95% CI, 0.74 to 1.13; P = .39). Although remission was not improved (88% v. 85%; P = .15), posthoc analyses found relapse risk (RR) was significantly reduced among GO recipients overall (3 years: 32.8% v. 41.3%; HzR, 0.73; 95% CI, 0.58 to 0.91; P = .006). Despite an increased postremission toxic mortality (3 years: 6.6% v. 4.1%; HzR, 1.69; 95% CI, 0.93 to 3.08; P = .09), disease-free survival was better among GO recipients (3 years: 60.6% v. 54.7%; HzR, 0.82; 95% CI, 0.67 to 1.02; P = .07).
conclusionGO added to chemotherapy improved EFS through a reduction in RR for children and adolescents with AML.
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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.