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OncoMatch/Clinical Trials/NCT04168502

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

Is NCT04168502 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Gemtuzumab Ozogamicin for acute myeloid leukemia.

Phase 3RecruitingGruppo Italiano Malattie EMatologiche dell'AdultoNCT04168502Data as of May 2026

Treatment: Gemtuzumab OzogamicinMRD driven study. Addition of gemtuzumab to conventional chemotherapy to reduce MRD of patients with favorable/intermediate-risk AML. Post-consolidation assessment of MRD.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Biomarker criteria

Excluded: FLT3 itd

Excluded: FLT3 tkd

Performance status

WHO 0–3

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: chemotherapy

Exception: no more than 7 days hydroxyurea

Patients previously untreated for their AML by other chemotherapeutic agents (except for no more than 7 days HU) or radiotherapy

Cannot have received: radiotherapy

Patients previously untreated for their AML by other chemotherapeutic agents (except for no more than 7 days HU) or radiotherapy

Lab requirements

Kidney function

serum creatinine ≤ 2 x the institutional uln

Liver function

total serum bilirubin ≤ 2 x uln; serum alt and ast ≤ 2.5 x uln

Cardiac function

left ventricular ejection fraction (lvef) ≥ 50%, as determined by echocardiogram

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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