Phase 2 Study of Two Quizartinib Dose Levels as Maintenance Treatment in Adults with FLT3-ITD Positive Acute Myeloid Leukemia in Complete Remission

What this Trial Is About

Researchers are evaluating two different doses of quizartinib as maintenance therapy for adults with FLT3-ITD positive acute myeloid leukemia AML who are in their first complete remission and have not undergone allogeneic hematopoietic stem cell transplantation. This Phase 2 clinical trial aims to assess the safety and effectiveness of these doses in helping maintain remission in this specific group of AML patients. The study also includes a Holter sub-study to examine how rapid heart rate changes might affect the heart safety of quizartinib. Participants are randomly assigned to receive either a higher or lower oral daily dose of quizartinib. The trial has two parallel treatment groups, each receiving one of the two dose levels. The maintenance therapy starts within 60 days after the last consolidation cycle of prior treatment. The study is open-label, meaning both participants and researchers know the dose being administered. Throughout the study, participants will be monitored for serious treatment-emergent adverse events from the first dose until 30 days after the last dose, with follow-up up to 87 months. Researchers will also track overall survival and relapse-free survival during this time. Participants will undergo regular evaluations, including physical exams, blood tests, and heart monitoring, to assess safety and treatment effects over the long term.

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