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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06513273

Acronym

Box

Enrollment

397

Registered

2024-07-22

Start date

2025-07-11

Completion date

2029-12-31

Last updated

2025-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia, Acute Myeloid Leukemia, Adult, AML, Adult

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Italy

Contacts

Primary ContactPaola Fazi

p.fazi@gimema.it0670390528

Backup ContactEnrico Crea

e.crea@gimema.it0670390514

Outcome results