NCT06513273

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
397

participants targeted

Target at P75+ for all trials

Timeline
43mo left

Started Jul 2025

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Jul 2025Dec 2029

First Submitted

Initial submission to the registry

July 16, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 22, 2024

Completed
12 months until next milestone

Study Start

First participant enrolled

July 11, 2025

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

4.4 years

First QC Date

July 16, 2024

Last Update Submit

August 8, 2025

Conditions

Acute Myeloid LeukemiaAML, AdultAcute Myeloid Leukemia, Adult

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

population of adult AML patients treated at Italian GIMEMA centers

You may qualify if:

  • 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.

You may not qualify if:

  • Patients included in interventional clinical trials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ematologia Ente Ecclesiastico Casa Sollievo Della Sofferenza

San Giovanni Rotondo, Italy

RECRUITING

UOC Ematologia AOU di SASSARI

Sassari, Italy

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Anna Candoni

    Haematology, University of Modena and Reggio Emilia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paola Fazi

CONTACT

0670390528p.fazi@gimema.it

Enrico Crea

CONTACT

0670390514e.crea@gimema.it

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2024

First Posted

July 22, 2024

Study Start

July 11, 2025

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

August 13, 2025

Record last verified: 2025-08

Locations

IT(2)