Protocol in Acute Myeloid Leukemia With FLT3-ITD

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 5 months 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 5 months after the last dose of chemotherapy)
• •Signed written informed consent.