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.
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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

Paola Fazi

0670390528

p.fazi@gimema.it

CONTACT

Enrico Crea

0670390514

e.crea@gimema.it

CONTACT