Study Impact on Outcome of Eltrombopag in Elderly Patients with Acute Myeloid Leukemia Receiving Induction Chemotherapy

Inclusion Criteria

* 60 years of age.
* AML de novo, except AML 3 and AML 7.
* AML with no adverse cytogenetic according to Medical Research Council (MRC) 2010 classification.
* Subjects should be eligible for intensive chemotherapy by Daunorubicine, cytarabine, Lomustine.
* Eastern Cooperative Oncology Group (ECOG) \< 3 (appendix 1).
* SORROR ≤ 3 (appendix 2).
* Adequate baseline organ function defined by the criteria below:

  * Total bilirubin ≤ 1.5 x Upper Limit of Normal (ULN) range except cases clearly not indicative of inadequate liver function
  * Alanine Aminotransferase (ALAT) and Aspartate Aminotransferase (ASAT) ≤ 3 x ULN
  * Creatinin ≤ 1.5 x ULN
* Adequate cardiac function with Left Ventricular Ejection fraction (LVEF) ≥50%
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
* Women will be menopausal to be enrolled
* The patient must give written (personally signed and dated) informed consent before completing any study-related procedure which means assessment or evaluation that would not form part of the normal medical care of the patient and before the start of induction chemotherapy.
* Affiliated to the French Social Security (Health Insurance).

Exclusion criteria

* Subjects with a diagnosis of acute promyelocytic (M3) or megakaryocytic leukemia (M7).
* AML with adverse cytogenetic according to the MRC 2010 classification.
* AML secondary to Myelodysplastic syndrome (MDS), Myeloproliferative neoplasm (MPN)
* Clinical symptoms suggesting active central nervous system leukemia, or presence of extramedullary AML.
* Previous exposure to anthracycline.
* Previous AML treatment other than hydroxyurea.
* Treatment with an investigational drug within 30 days or 5 half-life whichever is longer, preceding the first dose of study medication.
* History of thromboembolic event or other condition requiring ongoing use of anticoagulation either with warfarin or low molecular-weight heparin.
* History of another malignancy within the past three years except basal cell carcinoma of the skin or carcinoma in situ of the cervix.
* Pre-existing cardiovascular disease (including congestive heart failure, New York Heart Association (NYHA) Grade III/IV), or arrhythmia known to increase the risk of thromboembolic events (e.g. atrial fibrillation), or subjects with a QTc \>450 msec (QTc \>480 msec for subjects with Bundle Branch Block).
* Patient requiring platelets transfusion with platelets \> 10 x 10 Giga/L, for whatever reason.
* History of treatment with romiplostim or other Thrombopoietin receptor (TPO-R) agonists.
* Uncontrolled active infection.
* Any serious medical condition, laboratory abnormality, or psychiatric illness that would place the participant at an unacceptable risk or prevent them from giving informed consent.
* Known active HIV, Hepatitis B or C infection.
* Pregnancy or breastfeeding.