"InDACtion" vs "3+7" Induction in AML

Inclusion criteria:

1. Age ≥ 60 years
2. WHO Performance status ≤ 2
3. Eligible for standard intensive chemotherapy
4. Newly diagnosed AML cytopathologically confirmed to the WHO classification (up to 2months prior to randomization)
5. De novo or secondary AML is allowed
6. White blood cell (WBC) count is ≤ 30x10E9/L (measured within 72 hours prior torandomization).
7. Laboratory assessments (measured prior to randomization):
8. serum glutamate oxaloacetate transaminase (SGOT / ASAT) and serum glutamatepyruvate transaminase (SGPT / ALAT) < 2.5 x the upper limit of normal rangeunless considered AML-related
9. Total serum bilirubin < 2.5 x the upper limit of normal range unless consideredAML-related or due to Gilbert's syndrome
10. Serum creatinine < 2.5 x the upper limit of normal range unless consideredAML-related
11. Patients of reproductive potential should use adequate birth control measures, asdefined by investigator, during the study treatment period and for at least 3 monthsafter the last study treatment.
12. Before patient registration/randomization, written informed consent must be givenaccording to the International Conference of Harmonization good clinical practice (ICHGCP) and national/local regulations

Exclusion criteria:

1. Presence of acute promyelocytic leukemia (APL, i.e. AML-M3 with t(15;17)(q22;q12);promyelocytic leukemia - retinoic acid receptor-alpha (PML-RARA) fusion gene andcytogenetic variants)
2. Presence of blast crisis of chronic myeloid leukemia
3. Presence of active central nervous system (CNS) leukemia
4. Patients did not receive any prior treatment for AML (relapsed AML is not allowed),such as any antileukemic therapy including investigational agents and hypomethylatingagents (decitabine, 5-azacytidine). Treatment with hydroxyurea (HU) is allowed tocontrol the leukocytosis if given preferably for less than 5 days and is stopped atleast two days prior to the start of any of the protocol regimens
5. Patients received any prior treatment for myelodysplastic syndrome (MDS) ormyeloproliferative neoplasms (MPN) with:
6. hypomethylating agents (decitabine, 5-azacytidine), OR
7. with intensive chemotherapy or transplantation within the last three years
8. NOTE: The following treatments for previous MDS or MPN are allowed (up to onemonth before inclusion):

• Growth factors, thrombomimetics, immunosuppression (cyclosporin A, steroids,antithymocyte globulin etc.), chelation, interferons, anagrelide
• Lenalidomide, low-dose chemotherapy (low-dose melphalan, HU, low-dosecytarabine etc.), tyrosine-kinase inhibitors, histone deacetylase inhibitors (e.g. valproic acid, panobinostat etc.), mammalian target of rapamycin (mTOR) inhibitors, other experimental treatment that is not based oninhibition of deoxyribonucleic acid (DNA) methyltransferase

6. Presence of concomitant severe cardiovascular disease which would make intensivechemotherapy impossible, i.e. uncontrolled arrhythmias requiring chronic treatment,congestive heart failure or symptomatic ischemic heart disease, reduced leftventricular function assessed by multigated acquisition (MUGA) scan or echocardiogram
7. Presence of any malignancy (except basal and squamous cell carcinoma of the skin) forwhich the patient received systemic anticancer treatment within 6 months prior torandomization NOTE: Diagnosis of any previous or concomitant malignancy is thus not anexclusion criterion.
8. Presence of active uncontrolled infection
9. Presence of any psychological, familial, sociological or geographical condition in theopinion of the investigator potentially hampering compliance with the study protocoland follow-up schedule; those conditions should be discussed with the patient beforeregistration in the trial