A Phase II Study of Crenolanib in Relapsed/Refractory Acute Myeloid Leukemia Patients With FLT3 Activating Mutations

PHASE2CompletedINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

October 31, 2012

Primary Completion Date

April 30, 2019

Study Completion Date

April 30, 2019

Conditions
Acute Myeloid Leukemia With FLT3 Activating Mutations That Has Relapsed or Been Refractory After One or More Prior Therapies
Interventions
DRUG

Crenolanib besylate

"Crenolanib besylate, 100 mg TID, taken orally at least 30 minutes pre- or post- meal. Patients will complete a daily diary to record the date, time and amount (number of tablets) of crenolanib taken and eating schedule.~Concurrent hydroxyurea (maximum 5g total daily dose x 14 days) is permitted during the first 28 days of study therapy."

Trial Locations (1)

77030

MD Anderson Cancer Center, Houston

Sponsors
All Listed Sponsors
lead

Arog Pharmaceuticals, Inc.

INDUSTRY

NCT01657682 - A Phase II Study of Crenolanib in Relapsed/Refractory Acute Myeloid Leukemia Patients With FLT3 Activating Mutations | Biotech Hunter | Biotech Hunter