A Phase II Study of Crenolanib in Relapsed/Refractory Acute Myeloid Leukemia Patients With Activating FLT3 Mutations
This is a Phase II open label study of crenolanib besylate. This study will enroll subjects
with relapsed Acute Myeloid Leukemia (AML) with FLT3 activating mutations. Two cohorts of
patients will be enrolled: those whose AML has recurred after prior chemotherapy (not
including a FLT3 TKI), and those whose AML has progressed after prior therapy with a FLT3
TKI. Subjects will take 100mg (one tablet) of crenolanib three times a day until disease
progression, death, or the patient discontinues treatment for adverse events, investigator's
judgment, or other reasons.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate of patients receiving crenolanib therapy
To determine the response rate to crenolanib, including the rates of complete remission (CR), CR with incomplete blood count recovery (CRi), and partial remission (PR), in relapsed/refractory AML patients with FLT3 activating mutations after first cycle (28-days).
United States: Food and Drug Administration
|MD Anderson Cancer Center||Houston, Texas 77030-4096|