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
- 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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