Myeloid Leukemia, AcuteCLEV-LAM-2022NCT06764459
Molecular Characterization of Patients With Acute Myeloid Leukemia and the Impact of Clonal Evolution in the Response to Therapeutic Treatments
An observational study of Myeloid Leukemia, Acute, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloid Leukemia, Acute
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 15 Mar 2023to 31 Dec 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Flt3 mutated patients treated with specific inhibitors
Who may be able to join
- FLT3 mutated
Who cannot join
- Respoder to therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola
Bologna, 40138
Emanuela Ottaviani, MD, 00390512144055, emanuela.ottaviani@aosp.bo.it
About this study
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.
Read the detailed description
This study aims to analyze patients with mutated FLT3 AML treated with specific therapy by means of single-cell molecular characterization methods, to identify the presence of clones and subclones at onset and to be able to follow their evolution during therapeutic treatment. In this way, it is possible to study how the mutational profile varies under therapeutic pressure and identify any alterations responsible for resistance. It will thus be possible to define a panel of new molecular markers to be included in the diagnostic routine to identify early patients refractory/resistant to treatment with FLT3 inhibitors and thus improve the therapeutic approach of these patients.
- Conditions
- Myeloid Leukemia, Acute
- Keywords
- AML, FLT3, single cell sequencing
- Medical subject headings
- Leukemia, Myeloid, Acute
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the end of the enrollment 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start15 Mar 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloid Leukemia, AcuteStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emanuela Ottaviani, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764459
- Sponsor's protocol ID
- CLEV-LAM-2022
- Other IDs
- RC-2022-2773282
- Acronym
- CLEV-LAM-2022
- Status last verified
- Dec 2024
- First submitted
- 2 Jan 2025
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Characterization of Patients With Acute Myeloid Leukemia and the Impact of Clonal Evolution in the Response to Therapeutic Treatments
- ClinicalTrials.gov ID
- NCT06764459
- Acronym / sponsor ID
- CLEV-LAM-2022 / CLEV-LAM-2022
- Conditions
- Myeloid Leukemia, Acute
- Keywords
- AML, FLT3, single cell sequencing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study aims to analyze patients with mutated FLT3 AML treated with specific therapy by means of single-cell molecular characterization methods, to identify the presence of clones and subclones at onset and to be able to follow their evolution during therapeutic treatment. In this way, it is possible to study how the mutational profile varies under therapeutic pressure and identify any alterations responsible for resistance. It will thus be possible to define a panel of new molecular markers to be included in the diagnostic routine to identify early patients refractory/resistant to treatment with FLT3 inhibitors and thus improve the therapeutic approach of these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Flt3 mutated patients treated with specific inhibitors
Key inclusion criteria (1 listed)
- FLT3 mutated
Key exclusion criteria (1 listed)
- Respoder to therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Refractoriness to therapy
Time frame: At the end of the enrollment 3 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emanuela Ottaviani, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myeloid Leukemia, Acute, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emanuela Ottaviani, MD (0039 0512144055, emanuela.ottaviani@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Refractoriness to therapy (time frame: At the end of the enrollment 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.