Observational GIMEMA Study on the Outcome of Acute Myeloid Leukemia (AML) Patients Treated With New Drugs in Real-life

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Ematologia Ente Ecclesiastico Casa Sollievo Della Sofferenza
RECRUITING
San Giovanni Rotondo
UOC Ematologia AOU di SASSARI
RECRUITING
Sassari
Contact Information
Primary
Paola Fazi
p.fazi@gimema.it
0670390528
Backup
Enrico Crea
e.crea@gimema.it
0670390514
Time Frame
Start Date: 2025-07-11
Estimated Completion Date: 2029-12
Participants
Target number of participants: 397
Related Therapeutic Areas
Sponsors
Leads: Gruppo Italiano Malattie EMatologiche dell'Adulto

This content was sourced from clinicaltrials.gov