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)

Ematologia Ente Ecclesiastico Casa Sollievo Della Sofferenza

San Giovanni Rotondo, Italy

UOC Ematologia AOU di SASSARI

Sassari, Italy

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NCT06513273


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