NCT03379727 - Study to Assess the Safety and Efficacy of Midostaurin (PKC412) in Combination With Standard Chemotherapy During Induction and Consolidation Followed by 12 Months of Maintenance Monotherapy in Patients With Newly-diagnosed FMS-like Tyrosine 3 (FLT3) Kinase Receptor-mutated Acute Myeloid Leukemia. | Biotech Hunter

Enrollment

301

Participants

Timeline

Start Date

February 13, 2018

Primary Completion Date

July 9, 2021

Study Completion Date

July 9, 2021

Conditions

Acute Myeloid Leukemia

Interventions

DRUG

Midostaurin

Induction Phase: 50 mg (two 25 mg capsules) twice a day by mouth on days 8-28, for 1 - 2 cycles; a cycle = 28 days; Consolidation Phase: 50 mg (two 25 mg capsules) twice a day by mouth on days 8-28, for up to 4 cycles; Maintenance Phase: Continuous dosing (days 1 - 28) for up yo 12 cycles or until relapse, unacceptable toxicity, death, physician's decision, subject/guardian decision, protocol deviation, study termination by Sponsor, lost to follow-up, technical problems, pregnancy, subject withdrew consent, or until the end of study, whichever event occurred first.

DRUG

Cytarabine

Induction Phase (standard dose) (7 + 3 arm): 100-200 mg/m2/day by Continuous intravenous infusion (CIVI) days 1-7 (168 hours infusion); Induction Phase (5 + 2 arm): 100 mg/m2/day by CIVI days 1-5; Consolidation Phase: 1-3 g/m2 infusion over 3 hours every 12 h on days 1, 3 and 5, up to 4 cycles based on age and per investigator discretion

DRUG

anthracycline ((daunorubicin or idarubicin): Induction Phase only

daunorubicin (7 + 3 arm): 60-90 mg/m2/day by IV push on days 1-3 (with standard-dose cytarabine); daunorubicin (5 + 2 arm): 60 mg/m2/day by IV push on days 1-2; idarubicin (7 + 3 arm): 12 mg/m2/day by IV push on days 1-3 (with standard-dose cytarabine); idarubicin (5 + 2 arm): 12 mg/m2/day by IV push on days 1-2

Trial Locations (86)

1085

Novartis Investigative Site, Budapest

1413

Novartis Investigative Site, Sofia

1756

Novartis Investigative Site, Sofia

5021

Novartis Investigative Site, Bergen

5800

Novartis Investigative Site, Pleven

9000

Novartis Investigative Site, Varna

10000

Novartis Investigative Site, Zagreb

10128

Novartis Investigative Site, Torino

11000

Novartis Investigative Site, Belgrade

12100

Novartis Investigative Site, Cuneo

13419

Novartis Investigative Site, Tallinn

16132

Novartis Investigative Site, Genova

20089

Novartis Investigative Site, Rozzano

20122

Novartis Investigative Site, Milan

20132

Novartis Investigative Site, Milan

20162

Novartis Investigative Site, Milan

20900

Novartis Investigative Site, Monza

21034

Novartis Investigative Site, Dijon

24080

Novartis Investigative Site, León

24127

Novartis Investigative Site, Bergamo

25030

Novartis Investigative Site, Besançon

25123

Novartis Investigative Site, Brescia

28006

Novartis Investigative Site, Madrid

28046

Novartis Investigative Site, Madrid

28223

Novartis Investigative Site, Pozuelo de Alarcón

29100

Novartis Investigative Site, Piacenza

30174

Novartis Investigative Site, Venezia

33521

Novartis Investigative Site, Tampere

35010

Novartis Investigative Site, Las Palmas de Gran Canaria

35128

Novartis Investigative Site, Padua

37126

Novartis Investigative Site, Verona

38320

Novartis Investigative Site, San Cristóbal de La Laguna

40138

Novartis Investigative Site, Bologna

41124

Novartis Investigative Site, Modena

42123

Novartis Investigative Site, Reggio Emilia

42270

Novartis Investigative Site, Saint Priest En Jarez

43100

Novartis Investigative Site, Parma

46026

Novartis Investigative Site, Valencia

50134

Novartis Investigative Site, Florence

53100

Novartis Investigative Site, Siena

57085

Novartis Investigative Site, Metz

59037

Novartis Investigative Site, Lille

60126

Novartis Investigative Site, Ancona

64109

Novartis Investigative Site, Bayonne

65124

Novartis Investigative Site, Pescara

69373

Novartis Investigative Site, Lyon

69495

Novartis Investigative Site, Pierre-Bénite

71013

Novartis Investigative Site, San Giovanni Rotondo

73100

Novartis Investigative Site, Lecce

75012

Novartis Investigative Site, Paris

75475

Novartis Investigative Site, Paris

80131

Novartis Investigative Site, Napoli

80132

Novartis Investigative Site, Napoli

83100

Novartis Investigative Site, Avellino

84131

Novartis Investigative Site, Salerno

85107

Novartis Investigative Site, Bratislava

86000

Novartis Investigative Site, Poitiers

87042

Novartis Investigative Site, Limoges

87100

Novartis Investigative Site, Cosenza

90146

Novartis Investigative Site, Palermo

92141

Novartis Investigative Site, Clamart

94010

Novartis Investigative Site, Créteil

94800

Novartis Investigative Site, Villejuif

200136

Novartis Investigative Site, Craiova

700483

Novartis Investigative Site, Iași

625 00

Novartis Investigative Site, Brno

100 34

Novartis Investigative Site, Prague

FIN 00290

Novartis Investigative Site, Helsinki

FIN-90220

Novartis Investigative Site, Oulu

06202

Novartis Investigative Site, Nice

H 6725

Novartis Investigative Site, Szeged

04100

Novartis Investigative Site, Latina

06100

Novartis Investigative Site, Perugia

00128

Novartis Investigative Site, Roma

00133

Novartis Investigative Site, Roma

00161

Novartis Investigative Site, Roma

00168

Novartis Investigative Site, Roma

LT-08661

Novartis Investigative Site, Vilnius

833 10

Novartis Investigative Site, Bratislava

975 17

Novartis Investigative Site, Banská Bystrica

07120

Novartis Investigative Site, Palma de Mallorca

01009

Novartis Investigative Site, Vitoria-Gasteiz

08026

Novartis Investigative Site, Barcelona

08036

Novartis Investigative Site, Barcelona

501 82

Novartis Investigative Site, Borås

SE-751 85

Novartis Investigative Site, Uppsala