A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3 (FLT3) Mutation

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

276

Participants

Timeline

Start Date

October 25, 2017

Primary Completion Date

December 25, 2023

Study Completion Date

March 31, 2026

Conditions
AML With FLT3 Mutation
Interventions
DRUG

Gilteritinib

Tablet administered orally once daily.

DRUG

Cytarabine

Once/twice daily Intravenously (IV)/subcutaneously (SC).

DRUG

Mitoxantrone

Once daily IV injection.

DRUG

Etoposide

Once daily IV injection.

DRUG

G-CSF

Once daily IV/SC injection.

DRUG

Fludarabine

Once daily IV injection.

Trial Locations (49)

Unknown

Site CN103, Beijing

Site CN108, Beijing

Site CN109, Beijing

Site CN110, Beijing

Site CN131, Beijing

Site CN116, Changchun

Site CN120, Changsha

Site CN119, Fuzhou

Site CN102, Guangzhou

Site CN114, Guangzhou

Site CN121, Guangzhou

Site CN130, Guiyang

Site CN107, Hangzhou

Site CN118, Hefei

Site CN123, Huangpu Qu

Site CN117, Jinan

Site CN133, Lanzhou

Site CN128, Nanjing

Site CN106, Qingdao

Site CN126, Shanghai

Site CN129, Shanghai

Site CN125, Shenyang

Site CN101, Tianjin

Site CN105, Wuhan

Site CN122, Xi'an

Site CN132, Zhangzhou

Site CN113, Zhengzhou

Site CN136, Zhengzhou

Site MY306, Ampang

Site MY305, George Town

Site MY301, Johor Bahru

Site MY304, Kota Kinabalu

Site MY302, Kuala Lumpur

Site MY303, Pulau Pinang

Site RU506, Kemerovo

Site RU504, Krasnoyarsk

Site RU508, Moscow

Site RU509, Moscow

Site RU501, Saint Petersburg

Site RU502, Saint Petersburg

Site RU507, Saint Petersburg

Site SG401, Singapore

Site SG402, Singapore

Site SG403, Singapore

Site TH203, Bangkok

Site TH205, Bangkok

Site TH204, Chiang Mai

Site TH201, Khon Kaen

Site TH202, Khon Kaen

Sponsors
All Listed Sponsors
lead

Astellas Pharma Inc

INDUSTRY