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

NCT ID: NCT06513273

Last Updated: 2025-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

397 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-11

Study Completion Date

2029-12-31

Brief Summary

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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

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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.

Conditions

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Acute Myeloid Leukemia AML, Adult Acute Myeloid Leukemia, Adult

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gruppo Italiano Malattie EMatologiche dell'Adulto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anna Candoni

Role: PRINCIPAL_INVESTIGATOR

Haematology, University of Modena and Reggio Emilia

Locations

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Ematologia Ente Ecclesiastico Casa Sollievo Della Sofferenza

San Giovanni Rotondo, , Italy

Site Status RECRUITING

UOC Ematologia AOU di SASSARI

Sassari, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Paola Fazi

Role: CONTACT

0670390528

Enrico Crea

Role: CONTACT

0670390514

Facility Contacts

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Angelo Michele Carella

Role: primary

Claudio fOZZA

Role: primary

Other Identifiers

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AML2824

Identifier Type: -

Identifier Source: org_study_id

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