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
Daiichi Sankyo
Summary
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).
Description
This study also involves the Holter sub-study, which is designed to assess the impact of rapid acceleration in heart rate on the cardiac safety of quizartinib.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: 1. 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). 2. Newly diagnosed, morphologically documented primary AML or AML secondary to myelodysplastic syndrome or a myeloproliferative neoplasm based on the World Health Organization (WHO) 2008/2016 classification. 3. Participant has confirmed FLT3-ITD-positive (≥0.05 SR or ≥5% VAF) activating mutation from initial diagnosis in bone marrow or peripheral blood as determined by a local institution's validated molecular testing. 4. Participants…
Interventions
- DrugQuizartinib High Dose
Participants in Arm 1 will receive oral daily higher dose of quizartinib,
- DrugQuizartinib Low Dose
Participants in Arm 2 will receive oral daily lower dose of quizartinib
Locations (58)
- John Hopkins School of MedicineBaltimore, Maryland
- Umass Memorial Health Care SystemsWorcester, Massachusetts
- Roswell Park Cancer InstituteBuffalo, New York
- Weill CornellNew York, New York
- Westchester Medical CollegeValhalla, New York
- Clinical Research AllicanceWestbury, New York