iCare4: Genomic Signatures With Midostaurin in Acute Myeloid Leukemia (UF-HEM-004)

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

November 30, 2018

Primary Completion Date

January 31, 2021

Study Completion Date

January 31, 2022

Conditions
Acute Myeloid Leukemia
Interventions
DRUG

Midostaurin

"Induction Phase: 50 mg orally twice daily beginning on day 7 and ending 48 hours prior to beginning the consolidation phase~Consolidation Phase: 50 mg orally twice daily beginning on Day 6 and ending 48 hours prior to either the start of the next cycle or beginning conditioning therapy for allogenic stem cell transplant."

DRUG

Cytarabine

"Induction Phase: 3 g/m2 (patients 18-65 years old) or 1 g/m2 (patients \> 65 years old or those with co-morbidities precluding a higher dose) by vein over 3 hours every 12 hours on Days 1-6.~Consolidation Phase: 3 g/m2 (patients 18-65 years old) or 1 g/m2 (patients \> 65 years old or those with co-morbidities precluding a higher dose) by vein over 3 hours every 12 hours on Days 1, 3, and 5 of each cycle."

Trial Locations (1)

32610

University of Florida, Gainesville

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis Pharmaceuticals

INDUSTRY

lead

University of Florida

OTHER