Inclusion Criteria:

- Patients with suspected diagnosis of AML or related precursor neoplasm, or acute
leukemia of ambiguous lineage (classified according to the World Health Organization
(WHO) 2008 classification)

- Presence of FLT3-ITD assessed in the central AMLSG reference laboratories

- Patients considered eligible for intensive chemotherapy

- WHO performance status of ≤ 2

- Age ≥ 18 years and ≤ 70 years

- No prior chemotherapy for leukemia except hydroxyurea to control hyperleukocytosis (≤
7 days)

- Non-pregnant and non-nursing. Women of childbearing potential (WOCBP) must have a
negative serum or urine pregnancy test within a sensitivity of at least 25 mIU/mL
within 72 hours prior to registration ("Women of childbearing potential" is defined
as a sexually active mature woman who has not undergone a hysterectomy or who has had
menses at any time in the preceding 24 consecutive months)

- Female patients in the reproductive age and male patients must agree to avoid getting
pregnant or to father a child while on therapy and for 3 month after the last dose of
chemotherapy

- Women of child-bearing potential must either commit to continued abstinence from
heterosexual intercourse or begin one acceptable method of birth control (IUD, tubal
ligation, or partner's vasectomy). Hormonal contraception is an inadequate method of
birth control

- Men must use a latex condom during any sexual contact with women of childbearing
potential, even if they have undergone a successful vasectomy (while on therapy and
for 3 month after the last dose of chemotherapy)

- Signed written informed consent.

Exclusion Criteria:

•AML with the following recurrent genetic abnormalities (according to WHO 2008): AML with
t(8;21)(q22;q22); RUNX1-RUNX1T1 AML with inv(16)(p13.1q22) or t(16;16)(p13.1;q22);
CBFB-MYH11 AML with t(15;17)(q22;q12); PML-RARA (or variant translocations with other RARA
gene fusions)

- Performance status WHO >2

- Patients with ejection fraction < 50% by MUGA or ECHO scan within 14 days of day 1

- Organ insufficiency (creatinine >1.5x upper normal serum level; bilirubin, AST or ALP
>2.5x upper normal serum level, not attributable to AML; heart failure NYHA III/IV;
severe obstructive or restrictive ventilation disorder)

- Uncontrolled infection

- Severe neurological or psychiatric disorder interfering with ability of giving an
informed consent

- Patients with a "currently active" second malignancy other than non-melanoma skin
cancers. Patients are not considered to have a "currently active" malignancy if they
have completed therapy and are considered by their physician to be at less than 30%
risk of relapse within one year

- Known positive for HIV; active HBV, HCV, or Hepatitis A infection

- Bleeding disorder independent of leukemia

- No consent for registration, storage and processing of the individual
disease-characteristics and course as well as information of the family physician
and/or other physicians involved in the treatment of the patient about study
participation.

- No consent for biobanking.