Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML
Sponsor: Novartis Pharmaceuticals
Summary
This study will evaluate the safety, efficacy and pharmacokinetics of midostaurin in combination with standard chemotherapy in pediatrics patients with newly diagnosed FLT3-mutated Acute Myeloid Leukemia. The study has two parts: Part 1 to define the Recommended Phase 2 Dose, and Part 2 to evaluate safety and tolerability and efficacy of midostaurin. Both parts will consist of 2 induction blocks, 3 consolidation blocks, 12 cycles of post-consolidation consisting of continuous therapy with midostaurin, and a follow-up phase.
Official title: A Phase II, Open-label, Single Arm Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Twice Daily Midostaurin (PKC412) Combined With Standard Chemotherapy and as a Single Agent Post-consolidation Therapy in Children With Untreated FLT3-mutated AML
Key Details
Gender
All
Age Range
3 Months - 17 Years
Study Type
INTERVENTIONAL
Enrollment
22
Start Date
2019-03-13
Completion Date
2029-05-18
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
Midostaurin
midostaurin 30mg/m2 bid
Fludarabine
30mg/m2/day on D1-D5 of Block 2 FLADx
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
Daunorubicin or idarubicin
daunorubicin 60 mg/m2/day OR idarubicin 12mg/m2/day On D2, D4, D6 of Block 2 FLADx
Mitoxantrone
10mg/m2/day D3 and D4
Etoposide
100mg/m2/day D1 to D5
Locations (15)
Novartis Investigative Site
Prague, Czechia
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Essen, Germany
Novartis Investigative Site
Pavia, PV, Italy
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Torino, TO, Italy
Novartis Investigative Site
Naples, Italy
Novartis Investigative Site
Osaka, Japan
Novartis Investigative Site
Amman, Jordan
Novartis Investigative Site
Krakow, Poland
Novartis Investigative Site
Moscow, Russia
Novartis Investigative Site
Ljubljana, Slovenia
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Adana, Adana, Turkey (Türkiye)