Study of Quizartinib in Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
Acute Myeloid Leukemia
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring AML, phase 1, hematology, malignancy, newly diagnosed
Eligibility Criteria
Inclusion Criteria:
- No prior treatment for AML (including quizartinib)
- ECOG (Eastern Cooperative Oncology Group) Performance Status of 0 to 2
Exclusion Criteria:
- Diagnosis of acute promyelocytic leukemia
- Active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial or antiviral therapy.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Quizartinib 20 mg/day
Quizartinib 40 mg/day
Participants who received 20 mg quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m^2/day IV) and either idarubicin (12 mg/m^2/day IV infusion) or daunorubicin (60 mg/m^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m^2/12 hours IV) was co-administered with quizartinib.
Participants who received 40 mg quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m^2/day IV) and either idarubicin (12 mg/m^2/day IV infusion) or daunorubicin (60 mg/m^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m^2/12 hours IV) was co-administered with quizartinib.