OncoMatch/Clinical Trials/NCT04168502
Gemtuzumab Chemotherapy MRD Levels; Adult Untreated, de Novo, Fav Interm Risk AML
Is NCT04168502 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Targeted therapy
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Excluded: FLT3 itd
Excluded: FLT3 tkd
Performance status
WHO 0–3
Demographics
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.
Frequently asked questions
Is NCT04168502 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Are patients with FLT3 alterations eligible?
No. FLT3 itd is an exclusion criterion.
Are patients with FLT3 alterations eligible?
No. FLT3 tkd is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 60 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages