Evidence map›Paper›PMID 39503987›Full record

Trial reportInternational journal of hematology2025

A phase 1/2 study of gilteritinib in combination with chemotherapy in newly diagnosed patients with AML in Asia.

Masashi Sawa, Toshihiro Miyamoto, Hee-Je Kim, Yasushi Hiramatsu, June-Won Cheong, Takayuki Ikezoe, Tomoki Naoe, Koichi Akashi, Satoshi Morita, Masanori Kosako and 8 more

Abstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of hematology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. FLT3-Mutated AML: Transplanting with Precision in the Targeted Era.Current hematologic malignancy reports · 2026
    Review
  2. Article
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.

Masashi SawaDepartment of Hematology and Oncology, Aichi, Japan. msawa@wine.plala.or.jp.
Toshihiro MiyamotoDepartment of Hematology, Kanazawa University, Ishikawa, Japan.
Hee-Je KimCatholic Hematology Hospital, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
Yasushi HiramatsuDepartment of Hematology and Oncology, Japanese Red Cross Society Himeji Hospital, Hyogo, Japan.
June-Won CheongDepartment of Internal Medicine, Severance Hospital, Yonsei University Health System, Seoul, South Korea.
Takayuki IkezoeDepartment of Hematology, Fukushima Medical University Hospital, Fukushima, Japan.
Tomoki NaoeNational Hospital Organization Nagoya Medical Center, Aichi, Japan.
Koichi AkashiDepartment of Medicine and Biosystemic Science, Kyushu University Hospital, Fukuoka, Japan.
Satoshi MoritaKyoto University Graduate School of Medicine, Kyoto, Japan.
Masanori KosakoAstellas Pharma Inc, Tokyo, Japan.
Moyu IkegayaAstellas Pharma Inc, Tokyo, Japan.
Wataru TeradaAstellas Pharma Inc, Tokyo, Japan.
Takeshi KadokuraAstellas Pharma Inc, Tokyo, Japan.
Jason HillAstellas Pharma US, Inc., Northbrook, IL, USA.
Shuichi MiyawakiDivision of Hematology, Tokyo Metropolitan Otsuka Hospital, Tokyo, Japan.
Stanley C GillAstellas Pharma US, Inc., Northbrook, IL, USA.
Alexandra HeinlothAstellas Pharma US, Inc., Northbrook, IL, USA.
Nahla HasabouAstellas Pharma US, Inc., Northbrook, IL, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThis interim analysis of a phase 1/2, open-label, single-arm study assessed the safety, efficacy, and pharmacokinetics of gilteritinib plus chemotherapy in adults with newly diagnosed FLT3 mutation-positive acute myeloid leukemia.

methodsIn sequential phase 1 and 2 studies, induction and consolidation therapy with gilteritinib 120 mg/day plus chemotherapy (induction: idarubicin/cytarabine once daily; consolidation: cytarabine twice daily) was followed by maintenance gilteritinib 120 mg/day monotherapy. Endpoints included maximum tolerated dose (MTD), recommended expansion dose (RED), and dose-limiting toxicity (phase 1), and complete remission (CR) rate following induction therapy (primary endpoint), overall survival (OS), safety, and pharmacokinetics (phase 2).

resultsIn phase 1, MTD was not reached and RED was 120 mg/day. In phase 2, the CR rate was 50.0% after induction (90% confidence interval [CI] 40.4, 59.6); however, the lower confidence limit did not exceed the pre-defined 55% benchmark. Composite CR (CRc) rates were high following induction (86.6%, 95% CI [77.3, 93.1]), consolidation, and maintenance therapy (87.8%, 95% CI [78.7, 94.0], each). The probability of OS was 86.6% at 12 months. No new safety findings were reported.

conclusionIn this interim analysis, gilteritinib 120 mg/day in combination with chemotherapy was well tolerated, with similar CRc rates to previous studies.

Indexed as

Aniline CompoundsAntineoplastic Combined Chemotherapy ProtocolsLeukemia, Myeloid, AcutePyrazinesAdultAgedCytarabineFemalefms-Like Tyrosine Kinase 3HumansIdarubicinMaleMaximum Tolerated DoseMiddle AgedMutationTreatment OutcomeAniline CompoundsCytarabineFLT3 protein, humanfms-Like Tyrosine Kinase 3gilteritinibIdarubicinPyrazinesAcute myeloid leukemiaChemotherapyFLT3 mutationGilteritinibNewly diagnosed

Identifiers

PMID39503987
PMCPMC11748473

What OpenQuestion holds

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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.