Age

18–any

Sex

ALL

Healthy volunteers

Not accepted

1. 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.
2. FLT3 mutation positive (ITD, TKD or other)
3. ECOG PS 0-2
4. Adequate liver and renal function
5. Negative pregnancy test
6. Extramedullary leukemia allowed except CNS disease

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

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