Status:
RECRUITING
Observational Study on the Outcome of AML Patients Treated With New Drugs in Real-life (BoxTrial)
Lead Sponsor:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions:
Acute Myeloid Leukemia
AML, Adult
Eligibility:
All Genders
18+ years
Brief 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.
Detailed Description
This multicenter, prospective and retrospective observational study (model: case only) aims to evaluate the use and efficacy of new drugs or their combinations in real-life in a population of adult AM...
Eligibility Criteria
Inclusion
- 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
- Patients included in interventional clinical trials.
Key Trial Info
Start Date :
July 11 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
397 Patients enrolled
Trial Details
Trial ID
NCT06513273
Start Date
July 11 2025
End Date
December 1 2029
Last Update
August 13 2025
Active Locations (2)
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1
Ematologia Ente Ecclesiastico Casa Sollievo Della Sofferenza
San Giovanni Rotondo, Italy
2
UOC Ematologia AOU di SASSARI
Sassari, Italy