Gemtuzumab Chemotherapy MRD Levels; Adult Untreated, de Novo, Fav Interm Risk AML
Trial Parameters
Brief Summary
MRD driven study. Addition of gemtuzumab to conventional chemotherapy to reduce MRD of patients with favorable/intermediate-risk AML. Post-consolidation assessment of MRD.
Eligibility Criteria
Inclusion Criteria: 1. Signed written informed consent according to ICH/EU/GCP and national/local laws 2. Patients aged between 18 and 60 years 3. Patients previously untreated for their AML by other chemotherapeutic agents (except for no more than 7 days HU) or radiotherapy 4. Unequivocal diagnosis of de novo AML according to WHO diagnostic criteria (at least 20% blasts in the bone marrow), other than acute promyelocytic leukemia, documented by bone marrow aspiration (or biopsy in case of dry tap) (not supervening after other myeloproliferative disease or myelodysplastic syndromes of ≥ 6 months duration) 5. Patients with favorable-intermediate AML according to ELN 2017 (except for FLT3-ITD/TKD positive AML) 6. WHO performance status 0-3 7. Adequate renal (serum creatinine ≤ 2 x the institutional ULN) and liver (total serum bilirubin ≤ 2 x ULN; serum ALT and AST ≤ 2.5 x ULN) function, unless considered due to organ leukemic involvement 8. Left Ventricular Ejection Fraction (LVEF) ≥ 50%