Observational Study on the Outcome of AML Patients Treate... | NCT06513273

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

NCT06513273

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Status

Recruiting

Last Update Posted

Aug 13, 2025Actual

Enrollment

397Estimated

Phase

Not provided

Conditions

Acute Myeloid Leukemia
AML, Adult
Acute Myeloid Leukemia, Adult

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 11, 2025Actual

Primary Completion Date

Dec 2029Estimated

Completion Date

Dec 2029Estimated

First Submitted Date

Jul 16, 2024

First Submission Date that Met QC Criteria

Jul 16, 2024

First Posted Date

Jul 22, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 8, 2025

Last Update Posted Date

Aug 13, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

397Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged 18 years or older
AML diagnosis according to the ELN guidelines, excluding M3
Signed Informed consent, if applicable
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

population of adult AML patients treated at Italian GIMEMA centers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Paola Fazi	Contact	0670390528		p.fazi@gimema.it
Enrico Crea	Contact	0670390514		e.crea@gimema.it

Overall Officials

Name	Affiliation	Role
Anna Candoni	Haematology, University of Modena and Reggio Emilia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ematologia Ente Ecclesiastico Casa Sollievo Della Sofferenza	Recruiting	San Giovanni Rotondo			Italy

Condition Browse Module

MeSH Terms

ID	Term
D015470	Leukemia, Myeloid, Acute

Ancestor Terms

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided