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A Phase 3, Double-Blind, Placebo-controlled Study of Quizartinib Administered in Combination with Induction and Consolidation Chemotherapy, and Administered as Continuation Therapy in Subjects 18 to 75 Years Old with Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (QuANTUM First)

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Trial Profile

A Phase 3, Double-Blind, Placebo-controlled Study of Quizartinib Administered in Combination with Induction and Consolidation Chemotherapy, and Administered as Continuation Therapy in Subjects 18 to 75 Years Old with Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (QuANTUM First)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Jun 2025

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At a glance

  • Drugs Quizartinib (Primary) ; Cytarabine; Daunorubicin; Idarubicin
  • Indications Acute myeloid leukaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms QuANTUM-First
  • Sponsors Daiichi Sankyo Inc

Most Recent Events

  • 16 Jun 2025 According to a Daiichi Sankyo Inc media release, based on results from this trial VANFLYTA (quizartinib) has been approved by Health Canada for use in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by VANFLYTA maintenance monotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FMS-like tyrosine kinase 3-internal tandem duplication (FLT3-ITD) positive.1
  • 10 Dec 2024 Results (n=342) assessing FLT3-ITD detection using the MRD assay in paired bone marrow (BM) aspirates and peripheral blood (PB) samples, presented at the 66th American Society of Hematology Annual Meeting and Exposition
  • 02 Dec 2024 According to a Daiichi Sankyo Company media release, data from this trial will be presented in 3 Poster Sessions, at American Society of Hematology (#ASH24) Annual Meeting.

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