Evidence map›Paper›PMID 31473943›Full record

Trial reportInternational journal of hematology2019

Efficacy and safety of quizartinib in Japanese patients with FLT3-ITD positive relapsed or refractory acute myeloid leukemia in an open-label, phase 2 study.

Takeshi Takahashi, Kensuke Usuki, Kosei Matsue, Hitoshi Ohno, Toru Sakura, Ryota Imanaka, Masato Murakami, Shoichi Ohwada, Taiga Takagi, Sakura Sakajiri

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in International journal of hematology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02984995 (Phase 2 Open-label, Single-arm Study of Quizartinib), which is not on this map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
2.0field-weighted citation impact, top 13% of its field
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.

NCT02984995 phase2completednot on this map

Phase 2 Open-label, Single-arm Study of Quizartinib (AC220) Monotherapy in Japanese Patients With FLT3-ITD Positive Refractory or Relapsed Acute Myeloid Leukemia

TypeinterventionalSponsorDaiichi Sankyo Co., Ltd.Ran2016 to 2018Enrolled37ConditionsLeukemia, Myeloid, AcuteArmsQuizartinib
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 19 citations in OpenAlex.

  1. Trial
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  3. Observational
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  6. Review
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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

10 authors at 8 institutions in 1 country.

Takeshi TakahashiGifu Municipal Hospital, 7-1 Kashima-cho, Gifu, Japan. ttakahashi@gmhosp.gifu.gifu.jp.
Kensuke UsukiNTT Medical Center Tokyo, Tokyo, Japan.
Kosei MatsueKameda Medical Center, Kamogawa, Japan.
Hitoshi OhnoTenri Hospital, Tenri, Japan.
Toru SakuraSaiseikai Maebashi Hospital, Maebashi, Japan.
Ryota ImanakaHiroshima Red Cross and Atomic-bomb Survivors Hospital, Hiroshima, Japan.
Masato MurakamiDaiichi Sankyo Co., Ltd, Tokyo, Japan.
Shoichi OhwadaDaiichi Sankyo Co., Ltd, Tokyo, Japan.
Taiga TakagiDaiichi Sankyo Co., Ltd, Tokyo, Japan.
Sakura SakajiriJuntendo University, Urayasu Hospital, Urayasu, Japan.
Daiichi-Sankyo (Japan) · JPGifu Municipal Hospital · JPGunma Saiseikai Maebashi Hospital · JPHiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital · JPJuntendo University Urayasu Hospital · JPKameda Medical Center · JPNTT Medical Center · JPTenri Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

FMS-like tyrosine kinase 3 (FLT3) internal tandem duplication (ITD) mutations in patients with acute myeloid leukemia (AML) are associated with early relapse and poor survival. This multicenter, single-arm, two-stage phase 2 study (NCT02984995) was conducted to evaluate the efficacy and safety of quizartinib hydrochloride (initial dose 20/30 mg/day), an oral, highly potent, selective FLT3 inhibitor in Japanese patients (median age 65 years) with FLT3-ITD positive relapsed/refractory (R/R) AML. The composite complete remission (CRc) rate (primary endpoint) was 53.8% (90% confidence interval 36.2-70.8%) for evaluable patients in the efficacy analysis set. The median duration of CRc and overall survival was 16.1 weeks and 34.1 weeks, respectively. The most frequent treatment-emergent adverse events (TEAEs) were febrile neutropenia (43.2%), platelet count decreased (37.8%), and QT prolonged (35.1%). Two (5.4%) patients experienced TEAEs associated with treatment discontinuation. All serious TEAEs (45.9%), except febrile neutropenia (16.2%), were reported in ≤ 2 patients. The incidence of QTcF 451-480 ms and 481-500 ms was 37.8% and 2.7%, respectively. No QTcF > 500 ms, events of torsade de pointes or arrhythmia with clinical symptoms were reported. Quizartinib monotherapy was well tolerated and resulted in clinically meaningful reductions in blast count in Japanese patients with FLT3-ITD R/R AML.

Indexed as

AgedBenzothiazolesFemalefms-Like Tyrosine Kinase 3HumansJapanLeukemia, Myeloid, AcuteMaleMiddle AgedMutationPhenylurea CompoundsProtein Kinase InhibitorsRemission InductionSalvage TherapyTreatment OutcomeBenzothiazolesFLT3 protein, humanfms-Like Tyrosine Kinase 3Phenylurea CompoundsProtein Kinase InhibitorsquizartinibAcute myeloid leukemiaFLT3 inhibitorFLT3-ITD mutationQuizartinibRelapsed or refractory acute myeloid leukemia

Identifiers

PMID31473943
OpenAlexW2970675021

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.