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Using Gemtuzumab with Chemotherapy for Treating Acute Myeloid Leukemia

Phase 3 Study to Assess Gemtuzumab, in Combination With Standard Chemotherapy, on MRD Levels, in Adult, 18-60 Years, With Previously Untreated de Novo Fav-interm Risk AML

Phase 3 Interventional Gruppo Italiano Malattie EMatologiche dell'Adulto · NCT04168502

This study tests if adding a drug called gemtuzumab to regular chemotherapy can help people with certain types of acute myeloid leukemia have better treatment results and lower disease levels after their initial treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment414 (estimated)
Ages18 Years to 60 Years
SexAll
SponsorGruppo Italiano Malattie EMatologiche dell'Adulto Academic / other
Drugs / interventionschemotherapy, gemtuzumab
Locations48 sites (Alessandria and 47 other locations)
Trial IDNCT04168502 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the addition of gemtuzumab ozogamicin to standard chemotherapy in patients with favorable or intermediate-risk acute myeloid leukemia (AML) to reduce minimal residual disease (MRD) levels. It is a multicenter, MRD-driven study that assesses the effectiveness of this combination therapy in improving outcomes post-consolidation. The trial will evaluate the impact of MRD levels on the choice of post-remission therapy, specifically comparing autologous versus allogeneic stem cell transplants.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 60 with untreated de novo AML classified as favorable or intermediate risk.

Not a fit: Patients with acute promyelocytic leukemia or those with FLT3-ITD/TKD positive AML may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved treatment outcomes and survival rates for patients with AML.

How similar studies have performed: Other studies have shown promise with similar MRD-driven approaches in AML, suggesting potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Signed written informed consent according to ICH/EU/GCP and national/local laws
2. Patients aged between 18 and 60 years
3. Patients previously untreated for their AML by other chemotherapeutic agents (except for no more than 7 days HU) or radiotherapy
4. 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)
5. Patients with favorable-intermediate AML according to ELN 2017 (except for FLT3-ITD/TKD positive AML)
6. WHO performance status 0-3
7. 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
8. Left Ventricular Ejection Fraction (LVEF) ≥ 50%, as determined by echocardiogram
9. Absence of severe concomitant neurological or psychiatric diseases and congestive heart failure or active uncontrolled infection
10. Absence of any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and the follow-up schedule.

Exclusion Criteria:

1. Patients already treated for their AML by other chemotherapeutic agents (except for no more than 7 days HU) or radiotherapy
2. Acute promyelocytic leukemia
3. Blast crisis of chronic myeloid leukemia
4. FLT3-ITD/TKD positive AML
5. AML supervening after other myeloproliferative disease
6. AML supervening after antecedent myelodysplastic syndromes ≥ 6 months duration
7. Therapy-related AML
8. Other active or progressive malignant diseases.
9. Inadequate renal or liver function (metabolic abnormalities \> 2-2.5 times the normal upper limit)
10. Severe heart failure requiring diuretics
11. Ejection fraction \< 50%
12. Uncontrolled infections
13. Severe concomitant neurological or psychiatric diseases
14. 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.

Where this trial is running

Alessandria and 47 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Myeloid LeukemiaDe-novoFavorable riskIntermediate riskGemtuzumab ozogamicin
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.