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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

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.

Eligibility

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 details
    Acute Myeloid Leukemia
    AML
    Adult
    Acute Myeloid Leukemia
    Adult

NCT06513273

Gruppo Italiano Malattie EMatologiche dell'Adulto

13 September 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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