Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2017
Arsenic Trioxide Consolidation Allows Anthracycline Dose Reduction for Pediatric Patients With Acute Promyelocytic Leukemia: Report From the Children's Oncology Group Phase III Historically Controlled Trial AAML0631.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 51 papers.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
51 citing papers in PubMed, 89 citations in OpenAlex.
- Safety and efficacy of arsenic trioxide in intensification therapy for newly diagnosed childhood acute promyelocytic leukemia: results from the JPLSG AML-P13 study.International journal of hematology · 2026Trial
- Arsenic Combined With All-Trans Retinoic Acid for Pediatric Acute Promyelocytic Leukemia: Report From the CCLG-APL2016 Protocol Study.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2021Trial
- Retrospective analysis of data from 73 patients with childhood acute promyelocytic leukaemia receiving modified chemotherapy: a single-centre study.Journal of cancer research and clinical oncology · 2021Trial
- Outcome for pediatric acute promyelocytic leukemia patients at Children's Oncology Group sites on the Leukemia Intergroup Study CALGB 9710 (Alliance).Pediatric blood & cancer · 2019Trial
- Risk Markers for Significant Bleeding and Thrombosis in Pediatric Acute Promyelocytic Leukemia; Report From the Children's Oncology Group Study AAML0631.Journal of pediatric hematology/oncology · 2019Trial
- Multicenter randomized trial of arsenic trioxide and Realgar-Indigo naturalis formula in pediatric patients with acute promyelocytic leukemia: Interim results of the SCCLG-APL clinical study.American journal of hematology · 2018Trial
- Targeted therapies in pediatric oncology: A start.Molecular therapy. Oncology · 2026Review
- Regulatory Role of Zinc in Acute Promyelocytic Leukemia: Cellular and Molecular Aspects with Therapeutic Implications.International journal of molecular sciences · 2025Review
- Design, Conduct, and Analysis of Externally Controlled Trials.JAMA network open · 2025Article
- Clinical characteristics and outcome of pediatric patients with high-risk acute promyelocytic leukemia, with special focus on risk factors of early death.Annals of hematology · 2025Article
- A case report of TBL1XR1-RARB positive pediatric acute promyelocytic leukemia and literature review.Frontiers in oncology · 2025Article
- Analysis of the occurrence and liver function characteristics of arsenic-associated liver injury during the treatment of pediatric patients with acute promyelocytic leukemia.Annals of hematology · 2024Article
- Acute promyelocytic leukemia in children cancer hospital Egypt.Discover oncology · 2024Article
- Treatment of Pediatric Acute Promyelocytic Leukemia with Retinoic Acid and Arsenic Trioxide along with Chemotherapy.Indian journal of pediatrics · 2024Article
- Effects of Anionic Liposome Delivery of All-Biomimetics (Basel, Switzerland) · 2024Article
- Design of a clinical trial using generalized pairwise comparisons to test a less intensive treatment regimen.Clinical trials (London, England) · 2024Article
- Retinoid Therapy for Neuroblastoma: Historical Overview, Regulatory Challenges, and Prospects.Cancers · 2024Review
- Central venous catheters do not increase the hemorrhagic risk in acute promyelocytic leukemia patients during induction therapy.Frontiers in oncology · 2024Article
- Children's Oncology Group's 2023 blueprint for research: Myeloid neoplasms.Pediatric blood & cancer · 2023Article
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 1 institution in 1 country.
Funding
Abstract
Purpose The Children's Oncology Group AAML0631 trial for newly diagnosed pediatric acute promyelocytic leukemia (APL) was a phase III historically controlled trial to determine the survival of patients receiving arsenic trioxide (ATO) consolidation and reduced doses of anthracyclines. Patients and Methods Patients age 2 to 21 years with de novo APL confirmed by PML-RARα polymerase chain reaction were stratified as standard risk (SR) or high risk (HR) on the basis of diagnostic WBC count. All patients received all-trans retinoic acid (ATRA) during induction, each consolidation course, and maintenance. All patients received two cycles of ATO therapy during consolidation 1, an additional two (SR) or three (HR) consolidation courses that included high-dose cytarabine and anthracycline, and maintenance therapy comprising ATRA, oral methotrexate, and mercaptopurine. Results One hundred one patients (66 SR and 35 HR) were evaluable for outcome. The 3-year overall survival was 94%, and event-free survival (EFS) was 91%. For SR and HR patients with APL, the overall survival was 98% versus 86% ( P = .003), and EFS was 95% versus 83% ( P = .03), respectively. The EFS for SR patients in AAML0631 was noninferior to that of patients in the AIDA 0493 historical control, which used a significantly higher anthracycline dose and did not include ATO consolidation. Relapse risk for patients in AAML0631 from end consolidation 1 (after ATO treatment) was only 4% at 3 years and did not differ significantly between SR and HR patients. Conclusion ATO consolidation cycles were well tolerated in pediatric patients with APL and allowed significant reduction in cumulative anthracycline doses while maintaining excellent survival and a low relapse risk for both SR and HR patients with APL.
Indexed as
Identifiers
What OpenQuestion holds
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.