RecruitingNCT06513273
Observational Study on the Outcome of AML Patients Treated With New Drugs in Real-life (BoxTrial)
Observational GIMEMA Study on the Outcome of Acute Myeloid Leukemia (AML) Patients Treated With New Drugs in Real-life
Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
Enrollment
397 participants
Start Date
Jul 11, 2025
Study Type
OBSERVATIONAL
Conditions
Summary
This multicenter, prospective and retrospective observational study aims to evaluate the use and efficacy of new drugs or their combinations in real-life in a population of adult AML patients.
Eligibility
Min Age: 18 Years
Inclusion Criteria10
- Aged 18 years or older
- AML diagnosis according to the ELN guidelines, excluding M3
- Signed Informed consent, if applicable
- Treatment initiation with novel drugs in monotherapy or combination, in accordance with the AIFA authorizations, from the AIFA registration up to 31.12.2027 with particular attention to:
- patients affected by FLT3-mutated AML treated with gilteritinib.
- patients affected by IDH-mutated AML treated with IDH inhibitors.
- patients affected by AML in maintenance therapy with oral azacytidine.
- patients affected by AML treated with glasdegib.
- patients affected by AML treated with gemtuzumab ozogamicin.
- other novel drugs or combination for the treatment of AML approved during the study period.
Exclusion Criteria1
- Patients included in interventional clinical trials.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06513273
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