Safety and Efficacy Study of Nilotinib Combined With Mitoxantrone, Etoposide, and High-dose Cytarabine Induction Chemotherapy Followed by Consolidation for Patients With C-kit Positive Acute Myeloid Leukemia

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

October 31, 2010

Primary Completion Date

April 30, 2015

Study Completion Date

April 30, 2015

Conditions
Acute Myeloid Leukemia
Interventions
DRUG

NOVE-HiDAC

"NOVE-HiDAC consists of mitoxantrone, etoposide, and modified high-dose cytarabine. During induction patients will receive mitoxantrone by IV on Days 6-10, etoposide by IV on Days 6-10 and cytarabine by IV on Days 11-12.~During consolidation patients will be receiving mitoxantrone by IV on Days 1-10 and cytarabine by IV on Days 6, 8 and 10."

DRUG

Nilotinib

"The dose of nilotinib will be determined according to a dose escalation design. There will be three dose levels used in the study.~During induction, nilotinib will be given orally on Days 1-12.~During consolidation, nilotinib will be given orally on Days 1-10."

Trial Locations (1)

M5G 2M9

Princess Margaret Hospital, Toronto

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis Pharmaceuticals

INDUSTRY

lead

University Health Network, Toronto

OTHER