A Global Study of the Efficacy and Safety of Midostaurin + Chemotherapy in Newly Diagnosed Patients With FLT3 Mutation Negative (FLT3-MN) Acute Myeloid Leukemia (AML)

PHASE3CompletedINTERVENTIONAL
Enrollment

511

Participants

Timeline

Start Date

July 20, 2018

Primary Completion Date

February 12, 2021

Study Completion Date

February 12, 2021

Conditions
Acute Myeloid Leukemia (AML)
Interventions
DRUG

Midostaurin

Midostaurin was provided as 25 mg capsules 8PC, was supplied as double-blind in blister packs and taken orally.

DRUG

Placebo

Placebo was provided as 25 mg soft gelatin capsules 8PC, was supplied as double-blind in blister packs and taken orally.

DRUG

Chemotherapy

Along with the study drug/placebo, chemotherapy was given as well: either Daunorubicin or Idarubicin and Cytarabine - all taken by i.v.

Trial Locations (133)

1090

Novartis Investigative Site, Vienna

1140

Novartis Investigative Site, Vienna

1756

Novartis Investigative Site, Sofia

2060

Novartis Investigative Site, Antwerp

2145

Novartis Investigative Site, Westmead

3010

Novartis Investigative Site, Bern

3181

Novartis Investigative Site, Prahran

4102

Novartis Investigative Site, Woolloongabba

6150

Novartis Investigative Site, Murdoch

8000

Novartis Investigative Site, Bruges

8091

Novartis Investigative Site, Zurich

8800

Novartis Investigative Site, Roeselare

10002

Novartis Investigative Site, Taipei

10003

Novartis Investigative Site, Cáceres

10126

Novartis Investigative Site, Torino

10967

Novartis Investigative Site, Berlin

12351

Novartis Investigative Site, Berlin

13125

Novartis Investigative Site, Berlin

13353

Novartis Investigative Site, Berlin

14004

Novartis Investigative Site, Córdoba

15100

Novartis Investigative Site, Alessandria

15526

Novartis Investigative Site, Bad Saarow

18057

Novartis Investigative Site, Rostock

19049

Novartis Investigative Site, Schwerin

20099

Novartis Investigative Site, Hamburg

20162

Novartis Investigative Site, Milan

20246

Novartis Investigative Site, Hamburg

21034

Novartis Investigative Site, Dijon

23538

Novartis Investigative Site, Lübeck

24116

Novartis Investigative Site, Kiel

24127

Novartis Investigative Site, Bergamo

24939

Novartis Investigative Site, Flensburg

25123

Novartis Investigative Site, Brescia

28034

Novartis Investigative Site, Madrid

28041

Novartis Investigative Site, Madrid

29100

Novartis Investigative Site, Piacenza

30599

Novartis Investigative Site, Plzen-Bory

30625

Novartis Investigative Site, Hanover

31059

Novartis Investigative Site, Toulouse

33098

Novartis Investigative Site, Paderborn

33305

Novartis Investigative Site, Kuei Shan Chiang

35392

Novartis Investigative Site, Giessen

36100

Novartis Investigative Site, Vicenza

37007

Novartis Investigative Site, Salamanca

37075

Novartis Investigative Site, Göttingen

38114

Novartis Investigative Site, Braunschweig

39120

Novartis Investigative Site, Magdeburg

40225

Novartis Investigative Site, Düsseldorf

41013

Novartis Investigative Site, Seville

41124

Novartis Investigative Site, Modena

44093

Novartis Investigative Site, Nantes

44892

Novartis Investigative Site, Bochum

45239

Novartis Investigative Site, Essen Werden

46026

Novartis Investigative Site, Valencia

47166

Novartis Investigative Site, Duisburg

48903

Novartis Investigative Site, Barakaldo

49033

Novartis Investigative Site, Angers

49076

Novartis Investigative Site, Osnabrück

50009

Novartis Investigative Site, Zaragoza

52249

Novartis Investigative Site, Eschweiler

53105

Novartis Investigative Site, Bonn

55131

Novartis Investigative Site, Mainz

57072

Novartis Investigative Site, Siegen

59037

Novartis Investigative Site, Lille

60126

Novartis Investigative Site, Ancona

60637

University of Chicago Medical Center ., Chicago

61363

Novartis Investigative Site, Putzu City

64109

Novartis Investigative Site, Bayonne

64283

Novartis Investigative Site, Darmstadt

65124

Novartis Investigative Site, Pescara

66421

Novartis Investigative Site, Homburg

69495

Novartis Investigative Site, Pierre-Bénite

70176

Novartis Investigative Site, Stuttgart

70376

Novartis Investigative Site, Stuttgart

74100

Novartis Investigative Site, Taranto

75012

Novartis Investigative Site, Paris

76133

Novartis Investigative Site, Karlsruhe

80377

Novartis Investigative Site, München

83301

Novartis Investigative Site, Kaohsiung City

84000

Novartis Investigative Site, Avignon

89081

Novartis Investigative Site, Ulm

89124

Novartis Investigative Site, Reggio Calabria

90146

Novartis Investigative Site, Palermo

93053

Novartis Investigative Site, Regensburg

95123

Novartis Investigative Site, Catania

97080

Novartis Investigative Site, Würzburg

97239

Oregon Health and Science Univ, Portland

3109601

Novartis Investigative Site, Haifa

4941492

Novartis Investigative Site, Petah Tikva

6423906

Novartis Investigative Site, Tel Aviv

02115

Dana Farber Cancer Institute, Boston

C1118AAT

Novartis Investigative Site, CABA

A-4010

Novartis Investigative Site, Linz

90035-003

Novartis Investigative Site, Porto Alegre

04014-002

Novartis Investigative Site, São Paulo

01221 900

Novartis Investigative Site, São Paulo

625 00

Novartis Investigative Site, Brno - Bohunice

04103

Novartis Investigative Site, Leipzig

08060

Novartis Investigative Site, Zwickau

06129

Novartis Investigative Site, Perugia

00133

Novartis Investigative Site, Roma

00161

Novartis Investigative Site, Roma

00168

Novartis Investigative Site, Roma

466-8650

Novartis Investigative Site, Nagoya

790-8524

Novartis Investigative Site, Matsuyama

812-8582

Novartis Investigative Site, Fukuoka

960 1295

Novartis Investigative Site, Fukushima

500 8513

Novartis Investigative Site, Gifu

720-0001

Novartis Investigative Site, Fukuyama

305-8576

Novartis Investigative Site, Tsukuba

259-1193

Novartis Investigative Site, Isehara

852-8501

Novartis Investigative Site, Nagasaki

701-1192

Novartis Investigative Site, Okayama

573-1191

Novartis Investigative Site, Hirakata

589 8511

Novartis Investigative Site, Ōsaka-sayama

432-8580

Novartis Investigative Site, Hamamatsu

329-0498

Novartis Investigative Site, Shimotsuke

113-8677

Novartis Investigative Site, Bunkyo Ku

113-8603

Novartis Investigative Site, Bunkyo-ku

030 8553

Novartis Investigative Site, Aomori

606 8507

Novartis Investigative Site, Kyoto

534-0021

Novartis Investigative Site, Osaka

990 9585

Novartis Investigative Site, Yamagata

NO-5021

Novartis Investigative Site, Bergen

0424

Novartis Investigative Site, Oslo

80 952

Novartis Investigative Site, Gdansk

1099 023

Novartis Investigative Site, Lisbon

4200-072

Novartis Investigative Site, Porto

08907

Novartis Investigative Site, L'Hospitalet de Llobregat

08041

Novartis Investigative Site, Barcelona

01330

Novartis Investigative Site, Adana

06100

Novartis Investigative Site, Ankara

09100

Novartis Investigative Site, Aydin

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY