Evidence map›Paper›PMID 40906031›Full record

Trial reportInternational journal of hematology2026

Safety and efficacy of arsenic trioxide in intensification therapy for newly diagnosed childhood acute promyelocytic leukemia: results from the JPLSG AML-P13 study.

Hiroyuki Takahashi, Shiro Tanaka, Yuki Yuza, Yuka Iijima-Yamashita, Daisuke Hasegawa, Hiroshi Moritake, Kiminori Terui, Shotaro Iwamoto, Akira Shimada, Jun Matsubayashi and 8 more

Abstract readMulticenter StudyClinical Trial
PubMed Publisher
In one paragraph

Trial report in International journal of hematology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Hiroyuki TakahashiDepartment of Pediatrics, Toho University, 6-11-1, Omori-Nishi, Ota-ku, Tokyo, 143-8541, Japan. hiroyuki.takahashi@med.toho-u.ac.jp.ORCID http://orcid.org/0000-0001-8763-0280
Shiro TanakaDepartment of Clinical Biostatistics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Yuki YuzaDepartment of Hematology-Oncology, Tokyo Metropolitan Children's Medical Center, Tokyo, Japan.
Yuka Iijima-YamashitaDepartment of Advanced Diagnosis, Clinical Research Center, NHO Nagoya Medical Center, Aichi, Japan.
Daisuke HasegawaDepartment of Pediatrics, St. Luke's International Hospital, Tokyo, Japan.
Hiroshi MoritakeDivision of Pediatrics, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan.
Kiminori TeruiDepartment of Pediatrics, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.
Shotaro IwamotoDepartment of Pediatrics, Mie University Graduate School of Medicine, Tsu, Japan.
Akira ShimadaDepartment of Pediatrics, Jichi Medical University Hospital, Tochigi, Japan.
Jun MatsubayashiCenter for Clinical Research and Advanced Medicine, Shiga University of Medical Science, Otsu, Japan.
Takao DeguchiDivision of Cancer Immunodiagnostics, Children's Cancer Center, National Center for Child Health and Development, Tokyo, Japan.
Yoshiko HashiiDepartment of Pediatrics, Osaka International Cancer Institute, Osaka, Japan.
Nobutaka KiyokawaDepartment of Pediatric Hematology and Oncology Research, Research Institute, National Center for Child Health and Development, Tokyo, Japan.
Hayato MiyachiFaculty of Clinical Laboratory Sciences, Nitobe Bunka College, Tokyo, Japan.
Akiko M SaitoClinical Research Center, NHO Nagoya Medical Center, Nagoya, Japan.
Takashi TagaDepartment of Pediatrics, Shiga University of Medical Science, Otsu, Japan.
Souichi AdachiDepartment of Human Health Sciences, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Daisuke TomizawaDivision of Leukemia and Lymphoma, Children's Cancer Center, National Center for Child Health and Development, Tokyo, Japan.

Funding

Ministry of Health, Labour and Welfare H26-Kakushinteki Gan-Ippan-061National Center for Child Health and Development 22-5National Center for Child Health and Development 26-20
6 · The paper itself

Abstract

Arsenic trioxide (ATO) in combination with all-trans retinoic acid (ATRA) has been shown to be effective in both adult and pediatric patients with acute promyelocytic leukemia (APL). Addition of ATO to conventional chemotherapy could lead to a reduction in the doses of cytotoxic agents, but the long-term safety of ATO is not fully understood, especially in children. The Japan Children's Cancer Group conducted a risk-stratified prospective study to investigate safety and efficacy of ATO in children with newly diagnosed APL by replacing all three intensification phases with ATO. The 3-year event-free survival and overall survival rates in 27 children were 96.3% (95% CI 76.5%-99.5%) and 100% (95% CI 87.2%-100%), respectively. Prolonged QTc interval or other cardiac conduction disorders of any grade were observed in 20 out of the 63 intensification cycles. The durations of leukocytopenia, neutropenia, and G-CSF treatment were significantly shorter in this study than in a previous Japanese study that used conventional cytotoxic chemotherapy. Furthermore, no cardiac, metabolic, renal, cutaneous, or neurological symptoms were reported for up to 5 years after completion of the protocol therapy. The JPLSG AML-P13 study demonstrated excellent outcomes and safety of ATO in children with APL.

Indexed as

Antineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsArsenic TrioxideLeukemia, Promyelocytic, AcuteAdolescentChildChild, PreschoolDisease-Free SurvivalFemaleHumansInfantInfant, NewbornJapanMaleProspective StudiesSurvival RateAntineoplastic AgentsArsenic TrioxideTretinoinAcute promyelocytic leukemiaArsenic trioxideChildhood leukemiaClinical trial

Identifiers

PMID40906031

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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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.