Hairy Cell Leukemia (HCL)NCT06764524
Hairy Cell Leukemia: Harnessing the Full Power of Extracellular Vesicles to Improve Patient Care Management
An observational study of Hairy Cell Leukemia (HCL), run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
Check whether patients with Hairy Cell Leukemia (HCL) of different status (at diagnosis, in complete remission > 2 years or relapsed requiring therapy) have a 'signature' of altered immunity based on extracellular vesicles (EV) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hairy Cell Leukemia (HCL)
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 5 Dec 2024to 4 Dec 2027
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will be composed by Hairy Cell Leukemia patients (3 groups: patients at diagnosis (n=10); patients in complete response for >2 years (n=10); relapsed patients meeting treatment indications (n=5)) and by Healthy Donors (n=25) enrolled among volunteers of the no profit organization BolognAIL.
Who may be able to join
- WHO2022-defined diagnosis of Hairy Cell Leukemia.
- age ≥18 years.
- signed informed consent.
- age ≥18 years.
- Volunteers in general good health, free from any disease or serious illness.
- Signed informed consent.
Who cannot join
- None
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
Bologna, 40138
Lucia Catani, PhD, +390512143837, lucia.catani@unibo.it
About this study
Check whether patients with Hairy Cell Leukemia (HCL) of different status (at diagnosis, in complete remission > 2 years or relapsed requiring therapy) have a 'signature' of altered immunity based on extracellular vesicles (EV)
Read the detailed description
Extracellular vesicles are small particles detected within plasma and recognized as mediators of intercellular communication thanks to their cargo of proteins, lipids, and nucleic acids. However, the composition of vesicles from Hairy Cell Leukemia patients, which may hold the key to unraveling their involvement and function within tumor microenvironment, is totally unknown. The aim of this study is to characterize these extracellular vesicles in order to identify biology-related and disease-specific biomarkers.
- Conditions
- Hairy Cell Leukemia (HCL)
- Medical subject headings
- Leukemia, Hairy Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Extracellular vesicle characterization
Verify whether hairy cell leukemia patients at different status (at diagnosis, in complete remission > 2 years, or relapsed meeting treatment indications) display specific extracellular vesicle-based signatures of immune failure.
Measured: 2 years
Secondary outcomes (1)
Extracellular vesicles' functions and biomarker validation
Elucidate whether immune cells of hairy cell leukemia patients and of healthy donors show specific phenotype. Elucidate whether plasma-derived extracellular vesicles of hairy cell leukemia patients and of healthy donors affect the cross-talk between hairy cells and immune cells. Confirm the biomarkers identified by using bone marrow biopsy of hairy cell leukemia patients, at diagnosis or relapsed meeting treatment indications.
Measured: 2 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 start5 Dec 2024
- Primary completion5 Jun 2027 (estimated)
- Study completion4 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hairy Cell Leukemia (HCL)Studies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucia Catani, PhD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764524
- Sponsor's protocol ID
- EV-ABLE
- Other IDs
- RC-2024-2790616
- Status last verified
- Dec 2024
- First submitted
- 2 Jan 2025
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hairy Cell Leukemia: Harnessing the Full Power of Extracellular Vesicles to Improve Patient Care Management
- ClinicalTrials.gov ID
- NCT06764524
- Acronym / sponsor ID
- EV-ABLE
- Conditions
- Hairy Cell Leukemia (HCL)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 5 Jun 2027 (estimated)
- Study completion
- 4 Dec 2027 (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.
Check whether patients with Hairy Cell Leukemia (HCL) of different status (at diagnosis, in complete remission > 2 years or relapsed requiring therapy) have a 'signature' of altered immunity based on extracellular vesicles (EV)
Detailed description
Extracellular vesicles are small particles detected within plasma and recognized as mediators of intercellular communication thanks to their cargo of proteins, lipids, and nucleic acids. However, the composition of vesicles from Hairy Cell Leukemia patients, which may hold the key to unraveling their involvement and function within tumor microenvironment, is totally unknown. The aim of this study is to characterize these extracellular vesicles in order to identify biology-related and disease-specific biomarkers.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be composed by Hairy Cell Leukemia patients (3 groups: patients at diagnosis (n=10); patients in complete response for >2 years (n=10); relapsed patients meeting treatment indications (n=5)) and by Healthy Donors (n=25) enrolled among volunteers of the no profit organization BolognAIL.
Key inclusion criteria (6 listed)
- WHO2022-defined diagnosis of Hairy Cell Leukemia.
- age ≥18 years.
- signed informed consent.
- age ≥18 years.
- Volunteers in general good health, free from any disease or serious illness.
Key exclusion criteria (1 listed)
- None
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
Extracellular vesicle characterization
Time frame: 2 years
Verify whether hairy cell leukemia patients at different status (at diagnosis, in complete remission > 2 years, or relapsed meeting treatment indications) display specific extracellular vesicle-based signatures of immune failure.
1 secondary outcome
Extracellular vesicles' functions and biomarker validation
Time frame: 2 years
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 8 Jan 2025.
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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.
Lucia Catani, PhD 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 Hairy Cell Leukemia (HCL), 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 6 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 8 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 Lucia Catani, PhD (+390512143837, lucia.catani@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extracellular vesicle characterization (time frame: 2 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 8 Jan 2025.