A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial Of Quizartinib Administered in Combination With Induction and Consolidation Chemotherapy and Administered as Maintenance Therapy in Adult Patients With Newly Diagnosed FLT3-ITD Negative Acute Myeloid Leukemia
Daiichi Sankyo
Summary
This study will compare the effects of Quizartinib versus placebo in combination with chemotherapy in participants with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML).
Description
This is a clinical trial to compare the effect of quizartinib versus placebo (administered with standard induction and consolidation chemotherapy, then administered as maintenance therapy for up to 36 cycles) on the primary endpoint of overall survival (OS) in adult patients with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML). Participants will be tested for FLT3-ITD mutation status in a central laboratory using a validated assay.
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: 1. Must be competent and able to comprehend, sign, and date an Ethics Committee (EC)- or Institutional Review Board (IRB)-approved ICF before performance of any trial-specific procedures or tests. 2. ≥18 years or the minimum legal adult age (whichever is greater) and ≤70 years (at Screening). 3. Newly diagnosed, morphologically documented primary AML based on the World Health Organization (WHO) 2016 classification (at Screening) 4. Eastern Cooperative Oncology Group (ECOG) performance status (at the time the participant signs their ICF) of 0-2. 5. Participant is a cand…
Interventions
- DrugQuizartinib
Participants will receive quizartinib at 60 mg/day orally once daily
- DrugPlacebo
Participants will receive placebo at 60 mg/day orally once daily
- DrugChemotherapy
Participants will receive commercially available cytarabine (cytosine arabinoside) and anthracycline (daunorubicin or idarubicin).
Locations (288)
- City of Hope PhoenixGoodyear, Arizona
- Mayo Clinic - PhoenixPhoenix, Arizona
- University of Arizona Cancer CenterTucson, Arizona
- David Geffen School of MedicineLos Angeles, California
- University of California Davis Health SystemSacramento, California
- Ucsf - School of MedicineSan Francisco, California