QuANTUM-FIRST Trial
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Summary of the QuANTUM-First trial, a phase 3 study evaluating the efficacy and safety of a new FLT3-ITD inhibitor, added to standard chemo, compared to placebo + standard chemo.
Quizartinib Advancement Into the Next Generation of Trials for Unmet Needs in AML – First Line (QuANTUM-First) is a randomized, double-blind, placebo-controlled, global, phase 3 study evaluating the efficacy and safety of quizartinib compared to placebo + standard induction and consolidation CTa including allo-HSCT (quizartinib arm) versus placebo + standard CTa (placebo arm), followed by single-agent continuation therapy for up to ~3 years in adult patients with FLT3-ITD–positive newly diagnosed AML aged 18–75 years.
The primary endpoint of this study was OS. Secondary endpoints included EFS, CR, and CRc (CR + CRi) rates after induction, percentage of patients achieving CR with FLT3-ITD MRD negativity and CRc with FLT3-ITD MRD negativity, safety, and PK
References:ClinicalTrials.gov, NCT02668653; All graphs, images and tables shown were adapted from Erba HP, Montesinos P, Kim H-J, et al. Quizartinib plus chemotherapy in newly diagnosed patients with FLT3-internal-tandem-dupliation positive acute myeloid leukaemia (QuANTUM-First): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2023;401(10388):1571-1583
MED-BE-QUI-00011 - Dernière révision: Novembre 2024
Hématologie