Quizartinib in Combination With FLAG-IDA for Relapsed or Refractory Acute Myeloid Leukemia (FLAG-QUIDA): A PETHEMA Phase I-II Trial

Fecha de publicación:

Autores de IIS La Fe

Participantes ajenos a IIS La Fe

  • Bernal T.
  • Zambrano Márquez J.
  • Rodríguez-Arbolí E.
  • Bergua-Burgués J.M.
  • Vives S.
  • Arnán M.
  • Martínez Sánchez P.
  • Herrera-Puente P.
  • Serrano-López J.
  • Rubio V.
  • Marchante-Cepillo I.
  • Cervera-Calvo M.
  • Novo García A.
  • Fernández Martín R.
  • Gil Cortés C.
  • Rodríguez-Medina C.
  • Noriega-Concepción V.
  • Alfonso-Piérola A.
  • Loredo C.
  • Antuña-Casal M.
  • Sánchez-García J.
  • Bilbao C.
  • Gómez-Casares M.T.

Grupos

Abstract

Quizartinib is a tyrosine kinase inhibitor with single agent activity in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) and has demonstrated efficacy in first-line therapy when combined with intensive chemotherapy in both FLT3 ITD-negative and positive AML. The FLAG-QUIDA trial was a multicenter phase 1/2 study of quizartinib combined with FLAG-IDA in adult patients with first R/R AML. The primary objectives were to determine the recommended phase 2 dose (RP2D) in phase 1 and to establish the complete remission (CR) and CR with incomplete hematologic recovery (CRi) rates in phase 2. Nine patients were included in phase 1 and 52 in phase 2. Eighteen out of 61 (30%) patients were FLT3-ITD-positive. The RP2D of quizartinib was established at 60 mg/day for 14 days per 28-day cycle. Overall, the CR/CRi rate was 56% (n = 34), and the CR/CRi plus morphologic leukemia free state (MLFS) rate was 66% (n = 40), without differences across genetic subgroups. Measurable residual disease negativity was achieved in 38% (n = 13) of CR/CRi patients. Thirty-one patients (51%) were bridged to allogeneic stem cell transplantation after FLAG-QUIDA, 28 in CR/CRi and 3 in MLFS. Median relapse-free survival was 17 months as compared to 7.6 months in a cohort of matched patients treated with FLAG-IDA without quizartinib (p = 0.028), and median overall survival was 15.8 months in the FLAG-QUIDA cohort and 8.6 months in the matched cohort (p = 0.09). No safety concerns were raised. FLAG-IDA with quizartinib demonstrated promising efficacy in R/R AML, supporting future investigations. Trial Registration: EudraCT number: 2019-001976-12; ClinicalTrials.gov identifier: NCT04112589. © 2026 The Author(s). American Journal of Hematology published by Wiley Periodicals LLC.

Datos de la publicación

ISSN/ISSNe:
0361-8609, 1096-8652

AMERICAN JOURNAL OF HEMATOLOGY  WILEY

Tipo:
Article
Páginas:
-
PubMed:
42374628
Enlace a otro recurso:
www.scopus.com
Factor de Impacto:
2,600 SCImago ℠
Cuartil:
Q1 SCImago ℠

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Keywords

  • acute myeloid leukemia; chemotherapy; quizartinib; relapse

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