A Study of Midostaurin Efficacy and Safety in Newly Diagnosed Patients With FLT3-mutated AML

PHASE2CompletedINTERVENTIONAL
Enrollment

67

Participants

Timeline

Start Date

April 6, 2018

Primary Completion Date

November 14, 2022

Study Completion Date

November 14, 2022

Conditions
Acute Myeloid Leukemia
Interventions
DRUG

Midostaurin

Midostaurin 50 mg \[two 25 mg capsules\] were administered twice per day by mouth on day 8-21 during induction and consolidation phase; then on days 1-28 for 12 cycles in the continuation (post consolidation) phase.

DRUG

Placebo

Placebo, two capsules, were administered twice per day by mouth on day 8-21 during induction and consolidation phase; then on days 1-28 for 12 cycles in the continuation (post consolidation) phase.

Trial Locations (34)

10002

Novartis Investigative Site, Taipei

33305

Novartis Investigative Site, Taoyuan District

61363

Novartis Investigative Site, Putzu City

83301

Novartis Investigative Site, Kaohsiung City

100000

Novartis Investigative Site, Hanoi

123182

Novartis Investigative Site, Moscow

125284

Novartis Investigative Site, Moscow

197341

Novartis Investigative Site, Saint Petersburg

Unknown

Novartis Investigative Site, Pokfulam

466-8650

Novartis Investigative Site, Nagoya

470 1192

Novartis Investigative Site, Toyoake

277 8577

Novartis Investigative Site, Kashiwa

812-8582

Novartis Investigative Site, Fukuoka

960 1295

Novartis Investigative Site, Fukushima

064 0804

Novartis Investigative Site, Sapporo

259-1193

Novartis Investigative Site, Isehara

852-8501

Novartis Investigative Site, Nagasaki

701-1192

Novartis Investigative Site, Okayama

543-8555

Novartis Investigative Site, Osaka

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

141 8625

Novartis Investigative Site, Shinagawa Ku

030 8553

Novartis Investigative Site, Aomori

810-8563

Novartis Investigative Site, Fukuoka

781 8555

Novartis Investigative Site, Kochi

606 8507

Novartis Investigative Site, Kyoto

534-0021

Novartis Investigative Site, Osaka

990 9585

Novartis Investigative Site, Yamagata

06591

Novartis Investigative Site, Seoul

03722

Novartis Investigative Site, Seoul

06351

Novartis Investigative Site, Seoul

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY