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

Not yet recruiting

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

• Registration Number: NCT06513273
• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

Brief 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.

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 Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-16
• Study First Submitted QC: 2024-07-16
• Last Update Submitted: 2024-07-16
• Study First Posted: 2024-07-22
• Last Update Posted: 2024-07-22
• Study Start: 2024-11
• Primary Completion: 2029-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 397

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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