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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Myeloid Leukemia; AML, Adult; Acute Myeloid Leukemia, Adult

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 397

Contacts and Locations

• Study Contact: Name: Paola Fazi; Phone Number: 0670390528; Email: p.fazi@gimema.it
• Study Contact Backup: Name: Enrico Crea; Phone Number: 0670390514; Email: e.crea@gimema.it

Study Locations

• Italy
  • San Giovanni Rotondo, Italy
    • Recruiting
    • Ematologia Ente Ecclesiastico Casa Sollievo Della Sofferenza
    • Contact: Angelo Michele Carella
  • Sassari, Italy
    • Recruiting
    • UOC Ematologia AOU di SASSARI
    • Contact: Claudio fOZZA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

population of adult AML patients treated at Italian GIMEMA centers

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
New therapies efficacy in terms of Overall survival	evaluation of the efficacy of the new therapies or their combinations in the real-life for AML patients in terms of Overall Survival	at 24 months

Collaborators and Investigators

• Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Investigators: Principal Investigator: Anna Candoni, Haematology, University of Modena and Reggio Emilia

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: July 16, 2024
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): August 13, 2025
• Last Update Submitted That Met QC Criteria: August 8, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
• Other Study ID Numbers: AML2824

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No