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

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

Trial Details

NCT ID
NCT04168502
Phase
PHASE3
Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Gemtuzumab Ozogamicin
Locations (sample)
  • Alessandria, Italy|44.90924,8.61007
  • Ancona, Italy|43.60717,13.5103
  • Ascoli Piceno, Italy|42.85351,13.57395
  • Avellino, Italy|40.91494,14.79103
  • Bari, Italy|41.12066,16.86982

Key Eligibility Criteria

  • Signed written informed consent according to ICH/EU/GCP and national/local laws
  • Patients aged between 18 and 60 years
  • Patients previously untreated for their AML by other chemotherapeutic agents (except for no more than 7 days HU) or radiotherapy
  • Unequivocal diagnosis of de novo AML according to WHO diagnostic criteria (at least 20% blasts in the bone marrow), other than acute promyelocytic …

For full eligibility, visit ClinicalTrials.gov.

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