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Clinical Trial VICCHEM1423


A Phase 3 Open-Label Randomized Study of Quizartinib (AC220) Monotherapy Versus Salvage Chemotherapy in Subjects with FLT3-ITD Positive Acute Myeloid Leukemia (AML) Refractory To or Relapsed After First-line Treatment With or Without Hematopoietic Stem Cell Transplantation (HSCT) Consolidation

Principal Investigator(s)

Stephen Strickland


  • Protocol No. VICCHEM1423
  • Open Date: 08/08/2014
  • Staging: Phase III
  • Age Group: Adults
  • Scope: National
  • Objective: The primary objective of the study is to determine whether quizartinib monotherapy prolongs overall survival (OS) compared to salvage chemotherapy in subjects with FLT3-ITD(+) AML who are refractory to or have relapsed within 6 months, after first-line AML therapy.
  • Disease Sites: Leukemia
  • Therapies: Chemotherapy - cytotoxic; Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: AC220; Cytarabine (ARA-C); Etoposide; Filgrastim (GCSF); Fludarabine (Fludara); Idarubicin; Mitoxantrone; Quizartinib
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT02039726
  • Secondary Protocol No: AC220-007


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