Quizartinib in Combination With FLAG ‐ IDA for Relapsed or Refractory Acute Myeloid Leukemia ( FLAG ‐ QUIDA ): A PETHEMA Phase I‐ II Trial
Year: 2026
Type: article
Study design: Clinical Trial
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.
Source: American Journal of Hematology
DOI: 10.1002/ajh.70424
Authors: Teresa Bernal, Javier Zambrano Márquez, Rebeca Rodríguez‐Veiga, Eduardo Rodríguez‐Arbolí, Juan Manuel Bergua‐Burgués, Susana Vives, Montserrat Arnán, Pilar Martínez Sánchez, Pilar Herrera‐Puente, Josefina Serrano‐López, Vicente Rubio, Inmaculada Marchante‐Cepillo, Marta Cervera‐Calvo, Andrés Novo García, Rosa Fernández Martín, Cristina Gil Cortés, Carlos Rodríguez‐Medina, Victor Noriega‐Concepción, Ana Alfonso‐Piérola, Carmen Loredo, María Antuña‐Casal, Blanca Boluda, Isabel Cano‐Ferri, Evelyn Acuña‐Cruz, Laura Torres‐Miñana, Joaquín Sánchez‐García, Cristina Bilbao, Maria Teresa Gómez‐Casares, David Martínez Cuadrón, Pau Montesinos
Institutions: Hospital Universitario Central de Asturias, Instituto de Investigación Sanitaria del Principado de Asturias, Hospital Universitario San Agustín, Hospital Universitari i Politècnic La Fe, Consejo Superior de Investigaciones Científicas, Instituto de Biomedicina de Sevilla, Hospital Universitario Virgen del Rocío, Universidad de Sevilla, Hospital San Pedro de Alcántara, Josep Carreras Leukaemia Research Institute, Hospital Universitari Germans Trias i Pujol, Institut Català d'Oncologia, Hospital Universitario 12 De Octubre, Hospital Universitario Ramón y Cajal, Instituto Maimónides de Investigación Biomédica de Córdoba, Hospital Universitario Reina Sofía, University of Córdoba, Hospital Universitario de Jerez, Hospital Universitari Joan XXIII de Tarragona, Hospital Universitario Son Espases, Hospital Universitario Insular de Gran Canaria, Hospital General Universitario de Alicante Doctor Balmis, Hospital Universitario de Gran Canaria Doctor Negrín, Complexo Hospitalario Universitario A Coruña, Clinica Universidad de Navarra, Universitat de València
Language: English
Subfield: Hematology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $5,450
OpenAlex ID: W7166717766