Real-world outcomes for adults with AML treated with new drugs (BoxTrial)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter observational project combines prospective and retrospective data collection at Italian GIMEMA centers to describe how newly approved AML drugs and combinations are used in routine practice. It enrolls adults (≥18 years) with AML according to ELN guidelines, excluding acute promyelocytic leukemia (M3), who start AIFA-authorized novel therapies through 31 December 2027. No extra procedures or visits beyond standard clinical care are required, and each patient will be followed for a minimum of 24 months. The protocol focuses on patients treated with agents such as gilteritinib for FLT3-mutant AML, IDH inhibitors, oral azacitidine maintenance, glasdegib, gemtuzumab ozogamicin, and other drugs approved during the study period.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ematologia Ente Ecclesiastico Casa Sollievo Della Sofferenza
  San Giovanni Rotondo, Italy Recruiting
• UOC Ematologia AOU di SASSARI
  Sassari, Italy Recruiting

Study contacts

• Principal investigator: Anna Candoni — Haematology, University of Modena and Reggio Emilia
• Study coordinator: Paola Fazi
• Email: p.fazi@gimema.it
• Phone: 0670390528

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.