Evaluation of Two Dose Levels of Quizartinib as Maintenance in FLT3-ITD (+) Acute Myeloid Leukemia Patients in Complete Remission

This clinical two-arm trial is designed to evaluate two doses of quizartinib as maintenance therapy after induction/consolidation in participants with FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) (+) acute myeloid leukemia (AML) in first complete remission (CR) who have not received allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Trial Details

NCT ID
NCT06824168
Phase
PHASE2
Sponsor
Daiichi Sankyo
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Quizartinib High Dose
  • Quizartinib Low Dose
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Los Angeles, California, United States|34.05223,-118.24368
  • Baltimore, Maryland, United States|39.29038,-76.61219
  • Worcester, Massachusetts, United States|42.26259,-71.80229
  • Hackensack, New Jersey, United States|40.88593,-74.04347

Key Eligibility Criteria

  • Adults ≥18 years of age or the minimum legal adult age (whichever is greater) on the day of signing the ICF (no upper limit of age).
  • Newly diagnosed, morphologically documented primary AML or AML secondary to myelodysplastic syndrome or a myeloproliferative neoplasm based on the …
  • Participant has confirmed FLT3-ITD-positive (≥0.05 SR or ≥5% VAF) activating mutation from initial diagnosis in bone marrow or peripheral blood as …
  • Participants must have confirmed, morphologically documented CR1, on the most recent BMA, based on the local laboratory results, performed within 2…

For full eligibility, visit ClinicalTrials.gov.

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