NCT06764459

Brief Summary

This study aims to analyze patients with mutated FLT3 AML treated with specific therapy by means of molecular characterization methods, to identify the presence of clones and subclones at onset and to be able to follow their evolution during therapeutic treatment.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
8mo left

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

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 Progress83%
Mar 2023Dec 2026

Study Start

First participant enrolled

March 15, 2023

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 8, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

January 30, 2025

Status Verified

December 1, 2024

Enrollment Period

2.8 years

First QC Date

January 2, 2025

Last Update Submit

January 29, 2025

Conditions

Myeloid Leukemia, Acute

Keywords

AMLFLT3single cell sequencing

Outcome Measures

Primary Outcomes (1)

  • Refractoriness to therapy

    Selected patients, as they are mutated in FLT3, following therapy with specific inhibitors must show refractoriness to treatment in order to continue the study and investigate in single cell the presence of clones or subclones responsible for any relapses.

    At the end of the enrollment 3 years

Eligibility Criteria

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

Flt3 mutated patients treated with specific inhibitors

You may qualify if:

  • FLT3 mutated

You may not qualify if:

  • Respoder to therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Emanuela Ottaviani, MD

    IRCCS Azienda Ospedaliero-Universitaria di Bologna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emanuela Ottaviani, MD

CONTACT

0039 0512144055emanuela.ottaviani@aosp.bo.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2025

First Posted

January 8, 2025

Study Start

March 15, 2023

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

January 30, 2025

Record last verified: 2024-12

Locations

IT(1)