Using Gemtuzumab with Chemotherapy for Treating Acute Myeloid Leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• A.O. - SS. Antonio e Biagio e Cesare Arrigo - SC Ematologia
  Alessandria, Italy Recruiting
• Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona - Sod Clinica Ematologica
  Ancona, Italy Recruiting
• Area Vasta N. 5 Ascoli Piceno - S. Benedetto Del Tronto, Presidio Ospedaliero Av5 Osp. Gen. Prov.Le "C.G.Mazzoni" - Uoc Ematologia
  Ascoli Piceno, Italy Recruiting
• AO "San Giuseppe Moscati" - UOC Ematologia con unità di trapianto
  Avellino, Italy Recruiting
• AOU Consorziale Policlinico "Aldo Moro" - UO Ematologia con trapianto
  Bari, Italy Recruiting
• Policlinico S. Orsola - Malpighi - UOC Ematologia
  Bologna, Italy Recruiting

Study contacts

• Study coordinator: Paola Fazi
• Email: p.fazi@gimema.it
• Phone: 0670390528

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.