A Study of ASP2215 (Gilteritinib), Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects With FMS-like Tyrosine Kinase 3 (FLT3/ITD) Acute Myeloid Leukemia (AML) in First Complete Remission

PHASE2CompletedINTERVENTIONAL
Enrollment

98

Participants

Timeline

Start Date

January 10, 2017

Primary Completion Date

May 25, 2021

Study Completion Date

February 19, 2024

Conditions
Acute Myeloid Leukemia (AML)Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) / Internal Tandem Duplication (ITD) Mutation
Interventions
DRUG

Gilteritinib

Oral tablet

DRUG

Placebo

Oral tablet

Trial Locations (73)

112

Site TW88605, Kaohsiung City

114

Site TW88603, Taipei

161

Site IT39002, Roma

3000

Site PT35106, Coimbra

10408

Site KR82013, Goyang

10676

Site GR30010, Athens

11000

Site RS38102, Belgrade

13210

Site US10025, Syracuse

14584

Site KR82014, Bucheon-si

16499

Site KR82005, Suwon

20141

Site IT39011, Milan

24127

Site IT39008, Bergamo

26615

Site US10029, Greenville

29609

Site FR33004, Brest

31033

Site IT39004, Castelfranco Veneto (TV)

32204

Site US10030, Jacksonville

37044

Site FR33002, Tours

42100

Site IT39010, Reggio Emilia

47166

Site DE49001, Duisburg

49241

Site KR82006, Busan

54511

Site FR33014, Vandœuvre-lès-Nancy

57010

Site GR30004, Thessaloniki

58128

Site KR82003, Hwasungun

60612

Site US10012, Chicago

64100

Site FR33001, Bayonne

68070

Site FR33009, Mulhouse

69310

Site FR33007, Pierre-Bénite

70376

Site DE49008, Stuttgart

70852

Site CZ42001, Ostrava-Poruba

83301

Site TW88604, Kaohsiung City

91031

Site IL97205, Jerusalem

97239

Site US10007, Portland

32610-0278

Site US10017, Gainesville

74605-020

Site BR55002, Goiânia

B3H2Y9

Site CA15001, Halifax

M5G 2M9

Site CA15003, Toronto

DK 8000

Site DK45002, Aarhus

06189

Site FR33008, Nice

Unknown

Site GR30009, Athens

Site GR30007, Larissa

Site IT39005, Parma

Site JP81018, Nagoya

Site JP81025, Matsuyama

Site JP81002, Yoshida-gun

Site JP81024, Sapporo

Site JP81012, Kobe

Site JP81004, Kanazawa

Site JP81009, Yokohama

Site JP81014, Sendai

Site JP81023, Shimotsuke

Site JP81011, Tachikawa

Site JP81010, Aomori

Site JP81017, Okayama

Site PL48007, Poznan

Site RO40005, Bucharest

H-4400

Site HU36003, Nyíregyháza

10-228

Site PL48001, Olsztyn

85-168

Site PL48002, Bydgoszcz

4200-072

Site PT35101, Porto

405 760

Site KR82008, Namdong

06351

Site KR82012, Seoul

120-752

Site KR82009, Seoul

01009

Site ES34009, Vitoria-Gasteiz

171 76

Site SE46003, Stockholm

221 85

Site SE46002, Lund

EX2 5DW

Site GB44007, Exeter

PL6 8DH

Site GB44019, Plymouth

HU165JQ

Site GB44006, Cottingham

WC1E 6BT

Site GB44018, London

B95SS

Site GB44002, Birmingham

CF4 4XN

Site GB44015, Cardiff

LS9 7TF

Site GB44020, Leeds

NG5 1PB

Site GB44004, Nottingham

All Listed Sponsors
lead

Astellas Pharma Global Development, Inc.

INDUSTRY

NCT02927262 - A Study of ASP2215 (Gilteritinib), Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects With FMS-like Tyrosine Kinase 3 (FLT3/ITD) Acute Myeloid Leukemia (AML) in First Complete Remission | Biotech Hunter | Biotech Hunter