Study of Crenolanib Combined With Chemotherapy in FLT3-mutated Acute Myeloid Leukemia Patients

Inclusion Criteria

• Confirmed diagnosis of refractory/relapsed AML or high-risk MDS
• Arm 1: Subjects must have received at least one prior therapy and a maximum of three prior therapies
• Arm 2: Subjects must have received at least one prior therapy and a maximum of three prior therapies. No prior treatment with 5-Azacitidine is allowed in this arm.
• FLT3 mutation positive (ITD, TKD or other)
• ECOG PS 0-2
• Adequate liver and renal function
• Negative pregnancy test
• Extramedullary leukemia allowed except CNS disease

Exclusion Criteria

• Arm 1 and 2 Exclusion:
• <5% blasts in marrow or blood at time of screening
• Active HIV, hepatitis B or C
• CNS leukemia
• Clinically significant GVHD or organ dysfunction where chemotherapy specified by protocol cannot be given
• Patient with AML-M3 (APL)
• Pre-existing liver diseases (i.e. cirrhosis, chronic hepatitis B or C, nonalcoholic steatohepatitis, sclerosing cholangitis)