Trial reportAmerican journal of hematology2026
Quizartinib in Combination With FLAG-IDA for Relapsed or Refractory Acute Myeloid Leukemia (FLAG-QUIDA): A PETHEMA Phase I-II Trial.
Trial report in American journal of hematology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04112589 (A Multicenter, Prospective, Non-randomized, Phase I-II Trial to Assess the Efficacy and Safety of the Combination of Oral Quizartinib and the FLAG-IDA Chemotherapy Regimen in First Relapsed/Refractory Acute Myeloid Leukemia), which is not on this map. Not yet cited in PubMed.
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A Multicenter, Prospective, Non-randomized, Phase I-II Trial to Assess the Efficacy and Safety of the Combination of Oral Quizartinib and the FLAG-IDA Chemotherapy Regimen in First Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) Patients
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30 authors.
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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.
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