Gemtuzumab Chemotherapy MRD Levels; Adult Untreated, de Novo, Fav Interm Risk AML
Recruiting
Phase 3
Interventional Study
Acute Myeloid Leukemia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 60
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 414 (estimated)
- Sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto · Other
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About This Trial
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 Locations
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Eligibility 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 diagnosi…
Contacts