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QuANTUM-Wild: a Phase III, randomized trial of quizartinib in newly diagnosed FLT3-ITD–negative acute myeloid leukemia

Fecha de publicación:

Autores de IIS La Fe

Participantes ajenos a IIS La Fe

  • Altman J.K.
  • Bullinger L.
  • Cheong J.-W.
  • Fathi A.T.
  • Levis M.J.
  • Luger S.
  • Miyamoto T.
  • Oliva E.N.
  • Perl A.E.
  • Récher C.
  • Veiga R.R.
  • Wang J.
  • Zeidan A.M.
  • Liu L.
  • Duong Y.
  • Rohrbach J.E.C.
  • Inghirami G.
  • Alexis K.
  • Gosberg A.
  • Nahar A.
  • Burns K.
  • Daver N.
  • Erba H.P.

Grupos

Abstract

Quizartinib is a potent type II inhibitor of FMS-like tyrosine kinase 3 (FLT3) that demonstrated significant survival benefit among patients with newly diagnosed (ND) acute myeloid leukemia (AML) without FLT3-internal tandem duplication (FLT3-ITD) in the randomized, Phase II QUIWI trial. Here, we present the rationale and design of QuANTUM-Wild, a double-blind, randomized, placebo-controlled, Phase III study to confirm the efficacy and safety of quizartinib plus standard induction and consolidation chemotherapy and as maintenance monotherapy in adult patients with ND FLT3-ITD–negative AML. Eligible patients are randomized 2:2:1 to one of three treatment arms. Patients in Arm A (n ˜ 280) receive quizartinib plus chemotherapy during induction and consolidation (with option for transplant without study drug), followed by up to 36 cycles of single-agent maintenance therapy. Patients in Arm B (n ˜ 280) receive placebo in all treatment phases plus chemotherapy, then as maintenance monotherapy. Patients in Arm C (n ˜ 140) receive quizartinib plus chemotherapy in the induction and consolidation phases, then placebo during the maintenance phase, to specifically assess the utility of quizartinib maintenance. The primary endpoint is overall survival. Secondary endpoints include event-free survival, remission rate, and safety. Clinical trial registration:http://www.clinicaltrials.gov identifier is NCT06578247. © 2026 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.

Datos de la publicación

ISSN/ISSNe:
1479-6694, 1744-8301

Future Oncology  TAYLOR & FRANCIS LTD

Tipo:
Article
Páginas:
1913-1924
PubMed:
42434847
Enlace a otro recurso:
www.scopus.com
Factor de Impacto:
0,836 SCImago ℠
Cuartil:
Q2 SCImago ℠

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Keywords

  • Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Benzothiazoles; Double-Blind Method; Female; fms-Like Tyrosine Kinase 3; Humans; Leukemia, Myeloid, Acute; Male; Middle Aged; Phenylurea Compounds; Protein Kinase Inhibitors; Treatment Outcome; Young Adult; antineoplastic agent; benzothiazole derivative; carbanilamide derivative; CD135 antigen; FLT3 protein, human; protein kinase inhibitor; quizartinib; acute myeloid leukemia; adult; aged; clinical trial; controlled study; diagnosis; double blind procedure; drug therapy; female; genetics; human; male; middle aged; mortality; phase 3 clinical trial; randomized controlled trial; treatment outcome; young adult

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