A Study of ASP2215 (Gilteritinib) by Itself, ASP2215 Combined With Azacitidine or Azacitidine by Itself to Treat Adult Patients Who Have Recently Been Diagnosed With Acute Myeloid Leukemia With a FLT3 Gene Mutation and Who Cannot Receive Standard Chemotherapy

PHASE3CompletedINTERVENTIONAL
Enrollment

183

Participants

Timeline

Start Date

August 1, 2016

Primary Completion Date

March 10, 2023

Study Completion Date

December 18, 2024

Conditions
Acute Myeloid Leukemia (AML)Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation
Interventions
DRUG

gilteritinib

Tablet, oral

DRUG

azacitidine

Subcutaneous injection or intravenous infusion

Trial Locations (111)

704

Site TW88602, Tainan City

736

Site TW88609, Tainan City

1090

Site BE32007, Brussels

1200

Site BE32003, Brussels

2170

Site AU61004, Liverpool

3220

Site AU61007, Geelong

8041

Site ES34009, Barcelona

9000

Site BE32006, Ghent

10002

Site TW88601, Taipei

10003

Site ES34002, Cáceres

10021

Memorial Sloan-Kettering Cancer Center, New York

Weill Cornell Medical College-New York Presbyterian Hospital, New York

10449

Site TW88608, Taipei

11217

Site TW88610, Taipei

13353

Site DE49003, Berlin

14263

Roswell Park Cancer Institute, Buffalo

18057

Site DE49015, Rostock

20162

Site IT39004, Milan

26615

GHS Cancer Institute, Greenville

30029

Site FR33003, Nîmes

30625

Site DE49004, Hanover

33011

Site ES34003, Oviedo

33604

Site FR33002, Pessac

34295

Site FR33019, Montpellier

35033

Site FR33018, Rennes

38118

Site DE49012, Braunschweig

40138

Site IT39015, Bologna

44093

Site FR33001, Nantes

46026

Site ES34005, Valencia

49033

Site FR33009, Angers

49241

Site KR82014, Busan

59020

Site FR33004, Lille

59037

Site FR33006, Lille

59322

Site FR33023, Valenciennes

60126

Site IT39009, Ancona

60590

Site DE49005, Frankfurt am Main

60612

Rush University Medical Center, Chicago

63110

St. Louis University Cancer Center - Hematology/Oncology, St Louis

69310

Site FR33013, Pierre-Bénite

70376

Site DE49011, Stuttgart

71013

Site IT39011, San Giovanni Rotondo

72037

Site FR33017, Le Mans

72076

Site DE49002, Tübingen

76038

Site FR33015, Rouen

80131

Site IT39001, Napoli

81737

Site DE49007, München

83301

Site TW88604, Kaohsiung City

84143

LDS Hospital, Salt Lake City

86000

Site FR33012, Poitiers

90095

UCLA David Geffen School of Medicine, Los Angeles

90146

Site IT39006, Palermo

92868

University of California, Irvine Medical Center, Orange

60611-5975

Robert H. Lurie Comprehensive Cancer Center, Chicago

07601

Hackensack University Medical Center - John Theurer Cancer Center, Hackensack

07962

Hematology-Oncology Associates of Northern NJ, Morristown

SA 5000

Site AU61008, Adelaide

T6G 2B7

Site CA15009, Edmonton

M4N 3M5

Site CA15011, Toronto

M5G 2M9

Site CA15002, Toronto

H4A 3J1

Site CA15006, Montreal

Unknown

Site FR33020, Bayonne

Site IT39012, Florence

Site IT39007, Monza

Site IT39014, Novara

Site IT39005, Pavia

Site JP81018, Anjo

Site JP81007, Nagoya

Site JP81027, Matsuyama

Site JP81021, Fukuyama

Site JP81031, Sapporo

Site JP81033, Sapporo

Site JP81015, Kobe

Site JP81034, Hitachi

Site JP81023, Kanazawa

Site JP81001, Isehara

Site JP81032, Yokohama

Site JP81012, Sendai

Site JP81011, Kurashiki

Site JP81029, Shibuya-ku

Site JP81014, Shinagawa-ku

Site JP81035, Chiba

Site JP81008, Fukuoka

Site JP81024, Gifu

Site JP81005, Kumamoto

Site JP81016, Kyoto

Site JP81004, Nagasaki

Site JP81017, Nagasaki

Site JP81030, Osaka

Site JP81036, Osaka

Site JP81026, Tokushima

Site JP81019, Toyama

Site KR82010, Hwasun-gun

Site KR82015, Seongnam-si

Site ES34013, Madrid

Site TW88605, Kwei Shan Hsiang

06120

Site DE49009, Halle

20-081

Site PL48003, Lublin

02-776

Site PL48004, Warsaw

45-061

Site PL48002, Opole

10-228

Site PL48001, Olsztyn

405 760

Site KR82003, Namdong

05505

Site KR82013, Seoul

110-744

Site KR82006, Seoul

137-701

Site KR82002, Seoul

682-714

Site KR82001, Ulsan

156-707

Site KR82012, Seoul

07010

Site ES34007, Palma de Mallorca

08003

Site ES34008, Barcelona

08035

Site ES34004, Barcelona

08036

Site ES34010, Barcelona

S10 2JF

Site GB44007, Sheffield

All Listed Sponsors
lead

Astellas Pharma Global Development, Inc.

INDUSTRY

NCT02752035 - A Study of ASP2215 (Gilteritinib) by Itself, ASP2215 Combined With Azacitidine or Azacitidine by Itself to Treat Adult Patients Who Have Recently Been Diagnosed With Acute Myeloid Leukemia With a FLT3 Gene Mutation and Who Cannot Receive Standard Chemotherapy | Biotech Hunter | Biotech Hunter