Evidence map›Paper›PMID 40079105›Full record

Trial reportHaematologica2025

Impact of hematopoietic cell transplantation and quizartinib in newly diagnosed patients with acute myeloid leukemia and FMS-like tyrosine kinase 3-internal tandem duplications in the QuANTUM-First trial.

Richard F Schlenk, Pau Montesinos, Hee-Je Kim, Antonio Romero-Aguilar, Radovan Vrhovac, Elżbieta Patkowska, Pavel Žak, Po-Nan Wang, James Hanyok, Li Liu and 11 more

Erratum issued Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Haematologica, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02668653 (A Phase 3, Double-Blind, Placebo-controlled Study of Quizartinib Administered in Combination With Induction and Consolidation Chemotherapy, and Administered as Continuation Therapy in Subjects 18 to 75 Years Old With Newly Diagnosed FLT3-ITD), which is not on this map. Cited by 15 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 2 pooled it
–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.

NCT02668653 phase3completednot on this map

A Phase 3, Double-Blind, Placebo-controlled Study of Quizartinib Administered in Combination With Induction and Consolidation Chemotherapy, and Administered as Continuation Therapy in Subjects 18 to 75 Years Old With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (QuANTUM First)

TypeinterventionalSponsorDaiichi SankyoRan2016 to 2023Enrolled539ConditionsAcute Myeloid Leukemia, LeukemiaArmsChemotherapy, Quizartinib, Placebo
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. FLT3-Mutated AML: Transplanting with Precision in the Targeted Era.Current hematologic malignancy reports · 2026
    Review
  5. Review
  6. Article
  7. Review
  8. Review
  9. Review
  10. Haematologica · 2026
    Article
  11. All patients with AML andHaematologica · 2026
    Article
  12. Article
  13. Article
  14. Article
  15. Article
4 · The record

Corrections and comments

  • Erratum issued
    2026
5 · Who and what money

Authors and funding

21 authors.

Richard F SchlenkNational Center of Tumor Diseases Trial Center, German Cancer Research Center and Heidelberg University Hospital, Heidelberg, Germany; Department of Internal Medicine V, Heidelberg University Hospital, Heidelberg. richard.schlenk@nct-heidelberg.de.
Pau MontesinosHematology Department, La Fe University and Polytechnic Hospital, Valencia.
Hee-Je KimDepartment of Hematology, Catholic Hematology Hospital, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul.
Antonio Romero-AguilarUniversity Hospital Virgen de las Nieves, Granada.
Radovan VrhovacDivision of Hematology, University Hospital Centre Zagreb, Zagreb, Croatia.
Elżbieta PatkowskaInstitute of Hematology and Blood Transfusion, Warsaw.
Pavel ŽakDepartment of Internal Medicine-Haematology, University Hospital Hradec Kralove, Hradec Kralove, Czechia.
Po-Nan WangChang Gung Medical Foundation, Linkou.
James HanyokDaiichi Sankyo, Inc, Basking Ridge, NJ.
Li LiuDaiichi Sankyo, Inc, Basking Ridge, NJ.
Yasser Mostafa KamelDaiichi Sankyo, Inc, Basking Ridge, NJ.
Karima ImadalouDaiichi Sankyo, Inc, Basking Ridge, NJ.
Arnaud LesegretainDaiichi Sankyo, Inc, Basking Ridge, NJ.
Jorge CortesGeorgia Cancer Center at Augusta University Medical Center, Augusta, GA.
Mikkael A SekeresSylvester Cancer Center, University of Miami Health System, Miami, FL.
Herve DombretHopital Saint-Louis, Assistance Publique-Hopitax de Paris, Universite Paris Cite.
Sergio AmadoriTor Vergata Polyclinic Hospital Rome, Rome.
Jianxiang WangInstitute of Hematology and Blood Diseases Hospital, Tianjin.
Alexander E PerlDivision of Hematology/Oncology, University of Pennsylvania, Philadelphia, PA.
Mark J LevisDivision of Hematologic Malignancies, Johns Hopkins University, Baltimore, MD.
Harry P ErbaDuke Cancer Institute, Durham, NC.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

QuANTUM-First (ClinicalTrials.gov identifier: NCT02668653) was a randomized phase III trial in patients with newly diagnosed FLT3-internal tandem duplication (ITD)-positive acute myeloid leukemia (AML) treated with quizartinib or placebo plus standard induction and consolidation chemotherapy and/or allogeneic hematopoietic cell transplantation (allo-HCT), followed by single-agent maintenance therapy. We evaluated the impact of allo-HCT performed in first complete remission (CR1) or composite CR1 (CRc1) on overall survival (OS), considering treatment randomization. Post-hoc extended Cox regression multivariable analyses were conducted in patients who achieved complete remission/composite complete remission by the end of induction, including allo-HCT in CR1/CRc1 as a time-dependent variable to identify prognostic and predictive factors for OS. There were 297 patients with complete remission by the end of induction (quizartinib, N=147; placebo, N=150); of these, 157 (52.9%) underwent allo-HCT in CR1 (quizartinib, N=84; placebo, N=73). There were 368 patients with composite complete remission by the end of induction (quizartinib, N=192; placebo, N=176); of these, 196 (53.3%) underwent allo-HCT in CRc1 (quizartinib, N=110; placebo, N=86). Multivariable analyses revealed quizartinib treatment and allo-HCT in either CR1 (hazard ratio [HR]=0.553, 95% confidence interval [95% CI]: 0.383-0.798, P=0.0015 and HR=0.527, 95% CI: 0.349-0.796, P=0.0023, respectively) or CRc1 (HR=0.645, 95% CI: 0.470‒0.886, P=0.0068 and HR=0.557, 95% CI: 0.391-0.793, P=0.0012, respectively) as significant predictive factors for a longer OS. No new safety signals were identified. Patients who underwent protocol-specified allo-HCT in CR1/CRc1 experienced post-transplant-related complications, mostly grade ≥2 graft-versus-host disease, as expected. This post-hoc analysis further supports the use of quizartinib and allo-HCT in CR1/CRc1 as an efficacious and well-tolerated treatment strategy for newly diagnosed FLT3-ITD-positive AML patients fit for intensive chemotherapy.

Indexed as

Benzothiazolesfms-Like Tyrosine Kinase 3Hematopoietic Stem Cell TransplantationLeukemia, Myeloid, AcutePhenylurea CompoundsTandem Repeat SequencesAdolescentAdultAgedCombined Modality TherapyFemaleGene DuplicationHumansMaleMiddle AgedRemission InductionBenzothiazolesFLT3 protein, humanfms-Like Tyrosine Kinase 3Phenylurea Compoundsquizartinib

Identifiers

PMID40079105
PMCPMC12399959

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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.