Hairy Cell Leukemia: Harnessing the Full Power of Extracellular Vesicles to Improve Patient Care Management

January 2, 2025 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna
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)

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extracellular vesicles' functions and biomarker validation
Time Frame: 2 years
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

  • Principal Investigator: Lucia Catani, PhD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2024

Primary Completion (Estimated)

June 5, 2027

Study Completion (Estimated)

December 4, 2027

Study Registration Dates

First Submitted

January 2, 2025

First Submitted That Met QC Criteria

January 2, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 2, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EV-ABLE
  • RC-2024-2790616 (Other Grant/Funding Number: Italian Ministry of Health)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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