Clinical trial Recruiting at 3 sites Observational Ages 18 and up

Understanding how extracellular vesicles affect Hairy Cell Leukemia

Official title: Decoding the Extracellular Vesicles-driven Communication in the Microenvironment of Hairy Cell Leukemia to Improve Patient Care Management

Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06774677 · Data updated 2026-11-12

This study is trying to see how tiny particles in the blood affect Hairy Cell Leukemia and whether they help the cancer survive and avoid the immune system, involving both patients with the disease and healthy volunteers.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment50 (estimated)
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
Academic / other
Locations3 sites (Palermo, PA and 2 other locations)
StatusRecruiting
StartedDecember 12, 2024
Main results expectedAugust 11, 2026
Study endsAugust 30, 2026
Registry record updatedJanuary 14, 2025
Trial IDNCT06774677 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of Hairy Cell Leukemia.

Probably not a fit

Patients who do not have Hairy Cell Leukemia or are under 18 years old may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the role of extracellular vesicles in the microenvironment of Hairy Cell Leukemia (HCL). By analyzing these small particles found in plasma, the study seeks to uncover how they contribute to tumor maintenance and immune evasion. The research will involve multiple centers across the nation and will focus on identifying a specific signature related to disease outcomes based on the characteristics of these vesicles. Participants will include both patients diagnosed with HCL and healthy volunteers.

Why it matters

Potential benefit: If successful, this study could lead to improved patient care management and targeted therapies for Hairy Cell Leukemia.

How similar studies have gone: While the specific approach of this study is novel, similar studies investigating extracellular vesicles in other cancers have shown promising results.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion criteria for patients:

* WHO2022-defined diagnosis of Hairy Cell Leukemia.
* Age ≥18 years.
* Signed informed consent.

Inclusion criteria for Healthy Donors:

* Age ≥18 years.
* Volunteers in general good health, free from any disease or serious illness.
* Signed informed consent.

Exclusion criteria

\- None

Where it's running

  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello
    Palermo, PA, Italy
    Recruiting
  • Policlinico Santa Maria alla Scotte
    Siena, Si, Italy
    Recruiting
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna
    Bologna, Italy
    Recruiting

Study contacts

  • Principal investigator: Lucia Catani, PhD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
  • Study coordinator: Lucia Catani, PhD
  • Email: lucia.catani@unibo.it
  • Phone: +390512143837

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.