NCT03591510 - A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

March 13, 2019

Primary Completion Date

May 3, 2027

Study Completion Date

October 31, 2030

Conditions

FLT3-mutated Acute Myeloid Leukemia

Interventions

DRUG

Midostaurin

midostaurin 30mg/m2 bid

DRUG

Fludarabine

30mg/m2/day on D1-D5 of Block 2 FLADx

DRUG

Cytarabine

"Part 1:~2000mg/m2/day D1 to D5 of Block 2 FLADx 1000mg/m2 every 12 hours D1 to D3 Block 3 HAM 3000mg/m2 every 12 hours D1 to D3 Block 4 HA3E 3000mg/m2 every 12 hours D1 to D3 Block 5 HIDAC~Part 2:~1000mg/m2 every 12 hours D1 to D3 Block 2 HAM 3000mg/m2 every 12 hours D1 to D3 Block 3 HA3E 1000mg/m2 every 12 hours D1 to D3 Block 4 HAM 3000mg/m2 every 12 hours D1 to D3 Block 5 HIDAC"

DRUG

Daunorubicin or idarubicin

daunorubicin 60 mg/m2/day OR idarubicin 12mg/m2/day On D2, D4, D6 of Block 2 FLADx

DRUG

Mitoxantrone

10mg/m2/day D3 and D4

DRUG

Etoposide

100mg/m2/day D1 to D5

Trial Locations (17)

1000

Novartis Investigative Site, Ljubljana

1330

Novartis Investigative Site, Adana

10126

Novartis Investigative Site, Torino

11941

Novartis Investigative Site, Amman

13353

Novartis Investigative Site, Berlin

27100

Novartis Investigative Site, Pavia

45147

Novartis Investigative Site, Essen

80122

Novartis Investigative Site, Napoli

117198

Novartis Investigative Site, Moscow

625 00

Novartis Investigative Site, Brno

150 06

Novartis Investigative Site, Prague

06120

Novartis Investigative Site, Halle

00165

Novartis Investigative Site, Roma

534-0021

Novartis Investigative Site, Osaka

30-663

Novartis Investigative Site, Krakow

03080

Novartis Investigative Site, Seoul

05505

Novartis Investigative Site, Seoul