A Phase 2, Multicenter, Randomized, Open-label Trial to Evaluate Safety and Efficacy of Two Dose Levels of Quizartinib as Maintenance for Adult Patients with Newly Diagnosed FLT3-ITD + Acute Myeloid Leukemia in Complete Remission [Comparison of Two Dose Levels of Quizartinib as Maintenance in FLT3-ITD + Acute Myeloid Leukemia Patients in Complete Remission] (NCT06824168)

This clinical two-arm trial is designed to evaluate two doses of quizartinib (30mg/day or 60mg/day) 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 phase

Phase 2

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

A/Prof Shaun Fleming

Key inclusion data

Adults aged 18 years or older who have a type of blood cancer called acute myeloid leukaemia (AML) with a specific gene change (FLT3-ITD) confirmed in marrow or peripheral blood. You must be in your first complete remission after standard chemotherapy, with no visible leukaemia in the bone marrow or blood. Participants must have finished their main chemotherapy and be able to start the study treatment within about 2 months. Participants need to be well enough for daily activities and have heart, kidney, liver, and blood tests within safe ranges. People cannot join if they have certain rare types of leukaemia, active cancer in the brain or spinal fluid, serious heart problems, uncontrolled infections, or if they are pregnant or breastfeeding.