Observational Study on the Outcome of AML Patients Treated With New Drugs in Real-life (BoxTrial)

Gruppo Italiano Malattie EMatologiche dell'Adulto

Status: Enrolling

Conditions: Acute Myeloid Leukemia, Adult; AML, Adult; Acute Myeloid Leukemia

Study type: Observational

Funder types: Other

Identifiers

NCT06513273

AML2824

Details and patient eligibility

About

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.

Full 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 AML patients treated at Italian GIMEMA centers. No additional procedures or visits other than those required by normal clinical practice will be required. every patient will be followed for a minimum of 24 months.

Enrollment: 397 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged 18 years or older

2. AML diagnosis according to the ELN guidelines, excluding M3

3. Signed Informed consent, if applicable

4. 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 criteria

Patients included in interventional clinical trials.