Quizartinib in Combination With <scp>FLAG</scp> ‐ <scp>IDA</scp> for Relapsed or Refractory Acute Myeloid Leukemia ( <scp>FLAG</scp> ‐ <scp>QUIDA</scp> ): A <scp>PETHEMA</scp> Phase I‐ <scp>II</scp> Trial

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.

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Journal
American Journal of Hematology
Published
2026-06-29
DOI
https://doi.org/10.1002/ajh.70424
Primary Topic
Acute Myeloid Leukemia Research
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article
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article

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

Pau Montesinos, David Martínez Cuadrón, C E Loredo, Inmaculada Marchante-Cepillo et al.
American Journal of Hematology
Acute Myeloid Leukemia Research
article

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

Pau Montesinos, David Martínez Cuadrón, C E Loredo, Inmaculada Marchante-Cepillo, Laura Torres-Miñana, Isabel Cano‐Ferri, Andrés Novo García, Eduardo Rodríguez‐Arbolí, Cristina Bilbao, Juan Bergua, Víctor Noriega, Teresa Bernal, Vicente Rubio, María Teresa Gómez‐Casares, Pilar Herrera‐Puente, Josefina Serrano‐López, Cristina Gil Cortes, Montserrat Arnán, Evelyn Acuña‐Cruz, Rosa Fernandez Martin, Ana Alfonso‐Pierola, Pilar Martinez Sanchez, Joaquín Sánchez-García, Susana Vives, Maria Antuna-Casal, Carlos Rodríguez‐Medina, Rebeca Rodríguez‐Veiga, Blanca Boluda, Marta Cervera‐Calvo, Javier Zambrano Márquez
article en

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.

American Journal of Hematology
Universitat de València (ES), Hospital Universitario Insular de Gran Canaria (ES), Hospital Universitari i Politècnic La Fe (ES), Research Institute Hospital 12 de Octubre (ES), Hospital Universitario San Agustín (ES), Instituto Maimónides de Investigación Biomédica de Córdoba (ES), Hospital Universitario de Gran Canaria Doctor Negrín (ES), Hospital Universitario 12 De Octubre (ES), Institut Català d'Oncologia (ES), Hospital San Pedro de Alcántara (ES), Leitat Technological Center (ES), Hospital Universitario Reina Sofía (ES), Hospital Materno-Infantil (ES), Instituto de Biomedicina de Sevilla (ES), Hospital Universitario Central de Asturias (ES), Clinica Universidad de Navarra (ES), Hospital General Universitario de Alicante Doctor Balmis (ES), Complexo Hospitalario Universitario A Coruña (ES), Hospital Universitari Joan XXIII de Tarragona (ES), Hospital Universitario Son Espases (ES), Hospital Universitario Virgen del Rocío (ES), Hospital Universitari Germans Trias i Pujol (ES), Hospital Jerez Puerta del Sur (ES), Hospital Universitario Ramón y Cajal (ES), Instituto de Investigación Sanitaria La Fe (ES), Instituto de Investigación Sanitaria del Principado de Asturias (ES), Universidad de Navarra (ES)
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Openalex Percentile: Top 7%
Acute Myeloid Leukemia Research
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