Gemtuzumab Chemotherapy MRD Levels; Adult Untreated, de Novo, Fav Interm Risk AML

Korábbi kezelés

• Patients already treated for their AML by other chemotherapeutic agents (except for no more than 7 days HU) or radiotherapy
• Therapy-related AML
• Severe concomitant neurological or psychiatric diseases

Más betegség

• AML supervening after other myeloproliferative disease
• AML supervening after antecedent myelodysplastic syndromes ≥ 6 months duration
• Other active or progressive malignant diseases.
• Severe heart failure requiring diuretics
• Uncontrolled infections

Laborértékek

• Ejection fraction < 50%
• Patients who are pregnant or adults of reproductive potential not employing an effective method of birth control. Women of childbearing potential must have a negative serum pregnancy test within 48 hours prior to administration of chemotherapy. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients must agree to employ an effective barrier method of birth control throughout the study and for at least 6 months following discontinuation of study drug.

Egyéb

• Acute promyelocytic leukemia
• Blast crisis of chronic myeloid leukemia
• FLT3-ITD/TKD positive AML
• Inadequate renal or liver function (metabolic abnormalities > 2-2.5 times the normal upper limit)

• Signed written informed consent according to ICH/EU/GCP and national/local laws
• Patients aged between 18 and 60 years
• Patients previously untreated for their AML by other chemotherapeutic agents (except for no more than 7 days HU) or radiotherapy
• 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)
• Patients with favorable-intermediate AML according to ELN 2017 (except for FLT3-ITD/TKD positive AML)
• WHO performance status 0-3
• 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
• Left Ventricular Ejection Fraction (LVEF) ≥ 50%, as determined by echocardiogram
• Absence of severe concomitant neurological or psychiatric diseases and congestive heart failure or active uncontrolled infection
• Absence of any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and the follow-up schedule.