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

RECRUITINGSponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto
Actively Recruiting
SponsorGruppo Italiano Malattie EMatologiche dell'Adulto
Started2025-07-11
Est. completion2029-12
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06513273

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

Age: 18 Years+Healthy volunteers accepted
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.

Conditions4

AML, AdultAcute Myeloid LeukemiaAcute Myeloid Leukemia, AdultCancer

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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