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.
Treatment: Gemtuzumab Ozogamicin — MRD driven study. Addition of gemtuzumab to conventional chemotherapy to reduce MRD of patients with favorable/intermediate-risk AML. Post-consolidation assessment of MRD.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Excluded: FLT3 itd
Excluded: FLT3 tkd
Performance status
WHO 0–3
Prior therapy
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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