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

PHASE3CompletedINTERVENTIONAL
Enrollment

371

Participants

Timeline

Start Date

October 20, 2015

Primary Completion Date

September 17, 2018

Study Completion Date

February 25, 2025

Conditions
Leukemia, Acute Myeloid (AML)
Interventions
DRUG

gilteritinib

tablet, oral

DRUG

LoDAC (Low Dose Cytarabine)

subcutaneous (SC) or intravenous (IV) injection

DRUG

Azacitidine

SC or IV injection

DRUG

MEC (Mitoxantrone, Etoposide, Cytarabine)

IV injection

DRUG

FLAG-IDA (Granulocyte-Colony Stimulating Factor (G-CSF), Fludarabine, Cytarabine, Idarubicin)

SC (G-CSF) and IV (Fludarabine, Cytarabine, Idarubicin) injection

Trial Locations (126)

112

Site TW88606, Kaohsiung City

Site TW88611, Taipei

114

Site TW88602, Taipei

404

Site TW88608, Taichung

704

Site TW88601, Tainan City

5530

Site BE32002, Yvoir

10002

Site TW88603, Taipei

10029

Site US10037, New York

10032

Site US10008, New York

10065

Site US10013, New York

Site US10072, New York

10449

Site TW88610, Taipei

13210

Site US10046, Syracuse

14263

Site US10001, Buffalo

17007

Site ES34016, Girona

17033

Site US10041, Hershey

19104

Site US10010, Philadelphia

19107

Site US10080, Philadelphia

20132

Site IT39001, Milan

21100

Site IT39002, Varese

21201

Site US10005, Baltimore

25126

Site IT39010, Brescia

27100

Site IT39011, Pavia

27157

Site US10078, Winston-Salem

27710

Site US10024, Durham

29425

Site US10014, Charleston

29609

Site FR33013, Brest

30342

Site US10081, Atlanta

31059

Site FR33008, Toulouse

31096

Site IL97209, Haifa

32610

Site US10045, Gainesville

33305

Site TW88605, Taoyuan District

33604

Site FR33009, Pessac

35033

Site FR33014, Rennes

35043

Site DE49003, Marburg

37007

Site ES34014, Salamanca

40138

Site IT39005, Bologna

40202

Site US10074, Louisville

40705

Site TW88609, Taichung

43210

Site US10084, Columbus

44106

Site US10044, Cleveland

46026

Site ES34017, Valencia

48201

Site US10087, Detroit

49100

Site IL97206, Petah Tikva

53226

Site US10035, Milwaukee

55455

Site US10057, Minneapolis

59037

Site FR33010, Lille

60637

Site US10006, Chicago

66205

Site US10075, Westwood

70112

Site US10048, New Orleans

72076

Site DE49010, Tübingen

73104

Site US10058, Oklahoma City

76100

Site IL97208, Rehovot

78157

Site FR33002, Le Chesnay

78278

Site IL97201, Ashkelon

81737

Site DE49002, München

83301

Site TW88604, Kaohsiung City

90146

Site IT39004, Palermo

91031

Site IL97203, Jerusalem

91120

Site IL97210, Jerusalem

92868

Site US10076, Orange

94143

Site US10073, San Francisco

135710

Site KR82001, Seoul

137701

Site KR82002, Seoul

443380

Site KR82005, Suwon

602739

Site KR82010, Busan

35294-0006

Site US10011, Birmingham

90095-1752

Site US10012, Los Angeles

06504

Site US10067, New Haven

02114

Site US10034, Boston

02215

Site US10022, Boston

Site US10085, Boston

03756-1000

Site US10023, Lebanon

07601

Site US10027, Hackensack

08903

Site US10077, New Brunswick

37232-0656

Site US10063, Nashville

T6G 2G3

Site CA15004, Edmonton

L8V 1C3

Site CA15001, Hamilton

M5G 2M9

Site CA15015, Toronto

H1T 2M4

Site CA15003, Montreal

01307

Site DE49009, Dresden

04103

Site DE49011, Leipzig

00189

Site IT39007, Roma

Unknown

Site JP81002, Nagoya

Site JP81010, Narita

Site JP81026, Yoshida-gun

Site JP81016, Sapporo

Site JP81018, Kobe

Site JP81017, Tsukuba

Site JP81009, Isehara

Site JP81006, Yokohama

Site JP81012, Sendai

Site JP81007, Kurashiki

Site JP81014, Sayama

Site JP81020, Kawagoe

Site JP81027, Shimotsuke

Site JP81005, Chuo-ku

Site JP81004, Shinagawa-ku

Site JP81022, Shinjuku-ku

Site JP81023, Akita

Site JP81021, Aomori

Site JP81013, Kumamoto

Site JP81025, Kyoto

Site JP81008, Nagasaki

Site JP81024, Okayama

Site JP81011, Osaka

80-952

Site PL48002, Gdansk

45-372

Site PL48005, Opole

50-367

Site PL48004, Wroclaw

602-715

Site KR82009, Goyang

519-809

Site KR82003, Jeollanam-do

110-744

Site KR82007, Seoul

120-752

Site KR82004, Seoul

138-736

Site KR82008, Seoul

156-707

Site KR82011, Seoul

08025

Site ES34009, Badalona

08035

Site ES34011, Barcelona

08036

Site ES34012, Barcelona

08916

Site ES34010, Barcelona

08907

Site ES34005, L'Hospitalet de Llobregat

06100

Site TR90001, Ankara

06500

Site TR90004, Ankara

BH7 7DW

Site GB44014, Bournemouth

HA1 3UJ

Site GB44013, Harrow

M13 9WL

Site GB44003, Manchester

PL6 8DH

Site GB44015, Plymouth

All Listed Sponsors
lead

Astellas Pharma Global Development, Inc.

INDUSTRY

NCT02421939 - A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation | Biotech Hunter | Biotech Hunter