A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia.

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

97

Participants

Timeline

Start Date

February 26, 2015

Primary Completion Date

August 25, 2021

Study Completion Date

July 9, 2024

Conditions
Acute Myeloid LeukemiaFLT3-mutated Acute Myeloid Leukemia
Interventions
DRUG

Gilteritinib

Once-daily oral administration on 14 consecutive days in every cycle in each period.

DRUG

Idarubicin

Induction period: Once-daily intravenous injection of 12 mg/m\^2 idarubicin on 3 consecutive days.

DRUG

Cytarabine

"Induction period: Once-daily intravenous injection of 100 mg/m\^2 cytarabine on 7 consecutive days.~Consolidation period: Twice-daily intravenous injection of 1.5 g/m\^2 cytarabine on Days 1, 3, and 5."

Trial Locations (55)

Unknown

Site JP81037, Anjo

Site JP00003, Nagoya

Site JP81003, Nagoya

Site JP81027, Nagoya

Site JP81038, Toyohashi

Site JP81010, Narita

Site JP81039, Matsuyama

Site JP81007, Yoshida-gun

Site JP00002, Maebashi

Site JP81001, Maebashi

Site JP81026, Fukuyama

Site JP81018, Ōtake

Site JP81014, Sapporo

Site JP81015, Sapporo

Site JP81043, Himeji

Site JP00007, Kobe

Site JP81006, Kobe

Site JP81036, Mito

Site JP81023, Tsukuba

Site JP81020, Kanazawa

Site JP81013, Isehara

Site JP00006, Yokohama

Site JP81005, Yokohama

Site JP81024, Yokohama

Site JP81035, Sendai

SIte JP81011, Ōmura

Site JP81041, Tenri

Site JP81022, Shimono

Site JP81040, Bunkyo-ku

Site JP00005, Shinagawa-ku

Site JP81032, Shinagawa-ku

Site JP81029, Akita

Site JP81008, Chiba

Site JP00001, Fukuoka

Site JP81004, Fukuoka

Site JP81025, Fukuoka

Site JP81031, Fukushima

Site JP81030, Gifu

Site JP81033, Kochi

Site JP81028, Kumamoto

Site JP81016, Kyoto

Site JP81012, Nagasaki

Site JP81009, Okayama

Site JP81019, Osaka

Site JP81021, Osaka

Site KR82005, Busan

Site KR82002, Incheon

Site KR82001, Seoul

Site KR82003, Seoul

Site KR82004, Seoul

Site KR82006, Seoul

Site TW88604, Kaohsiung City

Site TW88602, Taichung

Site TW88601, Tainan City

Site TW88603, Taoyuan District

Sponsors
All Listed Sponsors
lead

Astellas Pharma Inc

INDUSTRY