GEMTUZUMAB OZOGAMICIN for Acute myeloid leukemia (favorable-intermediate risk)

Inclusion criteria

• {"criterion_text":"-Signed written informed consent according to ICH/EU/GCP and national/local laws"}
• {"criterion_text":"-Absence of any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and the follow-up schedule."}
• {"criterion_text":"-Women of childbearing potential with a negative serum pregnancy test within 48 hrs prior to administration of chemotherapy. Post-menopausal women with amenorrhoic for at least 12 months to be considered of non-childbearing potential. Male and female patients agreed to employ an effective barrier method of birth control throughout the study and for at least 6 months following discontinuation of study drug."}
• {"criterion_text":"-Patients aged between 18 and 60 years"}
• {"criterion_text":"-Patients previously untreated for their AML by other chemotherapeutic agents (except for no more than 14 days HU) or radiotherapy"}
• {"criterion_text":"-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)"}
• {"criterion_text":"-Patients with favorable-intermediate AML according to ELN 2017 (except for FLT3- ITD/TKD positive AML)"}
• {"criterion_text":"-WHO performance status 0-3"}
• {"criterion_text":"-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"}
• {"criterion_text":"-Left Ventricular Ejection Fraction (LVEF) = 50%, as determined by echocardiogram"}
• {"criterion_text":"-Absence of severe concomitant neurological or psychiatric diseases and congestive heart failure or active uncontrolled infection"}

Exclusion criteria

• {"criterion_text":"-Patients already treated for their AML by other chemotherapeutic agents (except for no more than 14 days HU) or radiotherapy"}
• {"criterion_text":"-Severe heart failure requiring diuretics"}
• {"criterion_text":"-Ejection fraction < 50%"}
• {"criterion_text":"-Uncontrolled infections"}
• {"criterion_text":"-HIV positive serology"}
• {"criterion_text":"-Severe concomitant neurological or psychiatric diseases"}
• {"criterion_text":"-Patients who are pregnant or adults of reproductive potential not employing an effective method of birth control"}
• {"criterion_text":"-Acute promyelocytic leukemia"}
• {"criterion_text":"-Blast crisis of chronic myeloid leukemia"}
• {"criterion_text":"-FLT3-ITD/TKD positive AML"}
• {"criterion_text":"-AML supervening after other myeloproliferative disease."}
• {"criterion_text":"-AML supervening after antecedent myelodysplastic syndromes ≥ 6 months duration"}
• {"criterion_text":"-Therapy-related AML"}
• {"criterion_text":"-Other active or progressive malignant diseases."}
• {"criterion_text":"-Inadequate renal or liver function (see no. 7 Inclusion )"}

Primary endpoints

• {"endpoint_text":"-Percentage of MRD negativity after consolidation in patients treated in induction and consolidation with GO","definition_or_measurement_approach":"Not specified in record"}

Secondary endpoints

• {"endpoint_text":"-Overall Survival (OS) at 24 months","definition_or_measurement_approach":"Not specified in record"}
• {"endpoint_text":"-Event Free Survival (EFS) at 24 months","definition_or_measurement_approach":"Not specified in record"}
• {"endpoint_text":"-Cumulative incidence of relapse (CIR) at 24 months","definition_or_measurement_approach":"Not specified in record"}
• {"endpoint_text":"-Response rate in terms of patients who achieve CR after induction therapy","definition_or_measurement_approach":"Not specified in record"}
• {"endpoint_text":"-Safety in terms of number and type of adverse events (AE) and serious AE (SAE)","definition_or_measurement_approach":"Not specified in record"}
• {"endpoint_text":"-OS, EFS, DFS and CIR in favorable and intermediate risk groups","definition_or_measurement_approach":"Not specified in record"}
• {"endpoint_text":"-OS, EFS, DFS and CIR according to the MRD level after induction and consolidation","definition_or_measurement_approach":"Not specified in record"}
• {"endpoint_text":"-Response rate, OS, EFS, DFS and CIR according to morphology, cytogenetic and molecular baseline characteristics.","definition_or_measurement_approach":"Not specified in record"}

Italy

Earliest CTIS Part Ii Submission Date

22-12-2023

Latest Decision Or Authorization Date

13-05-2026

Processing Time Days

873

Number Of Participants

414

Primary sponsor

Full Name

Fondazione Gimema Franco Mandelli Onlus

Organisation Type

Patient organisation/association

Country Of Registered Address

Italy

Third parties

• {"country":"Italy","full_name":"Laboratorio di Diagnostica Integrata Oncoematologica “OPPO”","duties_or_roles":"4","organisation_type":"Health care"}
• {"country":"","full_name":"Pfizer","duties_or_roles":"Monetary support","organisation_type":""}