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

This is a national multi-centre, experimental, cross-sectional, non-profit study.

Study Overview

• Status: Recruiting
• Conditions: Hairy Cell Leukemia (HCL)

Detailed Description

Extracellular vesicles are small particles circulating in plasma and documented as key players of intercellular crosstalk thanks to their cargo of proteins, lipids, and nucleic acids. The driving hypothesis of this study is that in Hairy Cell Leukemia-derived extracellular vesicles contribute to the maintenance of the tumor clone through regulation of selected key cells of the tumor microenvironment including immune cells and stromal cells, likely favoring immune evasion and marrow fibrosis. As a consequence, these circulating particles may be instrumental at identifying a biology-related, disease-specific and extracellular vesicle-based signature associated to outcomes.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Lucia Catani, PhD; Phone Number: +390512143837; Email: lucia.catani@unibo.it

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • IRCCS Azienda Ospedaliero-Universitaria di Bologna
    • Contact: Lucia Catani, PhD; Phone Number: +390512143837; Email: lucia.catani@unibo.it
  • PA
    • Palermo, PA, Italy, 90121
      • Recruiting
      • Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello
      • Principal Investigator: Caterina Patti, MD
      • Contact: Caterina Patti, MD
  • SI
    • Siena, SI, Italy, 53100
      • Recruiting
      • Policlinico Santa Maria alla Scotte
      • Contact: Alessandro Gozzetti, MD
      • Principal Investigator: Alessandro Gozzetti, MD

Participation Criteria

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 subdivided as newly diagnosed (n=10), relapsed meeting treatment indications (N=5) and in complete response >2 years (N=10) and by Healthy Donors (n=25), enrolled among volunteers through the non-profit organization AIL Bologna ODV.

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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional effects of extracellular vesicles	Elucidate whether plasma-derived extracellular vesicles of hairy cell leukemia patients and healthy donors and in vitro hairy cell-derived extracellular vesicles may functionally educate the immune microenvironment. Elucidate whether plasma-derived extracellular vesicles of patients and healthy donors may functionally affect the isolated hairy cells. Understand whether plasma-derived extracellular vesicles of patients and healthy donors and in vitro hairy cell-derived extracellular vesicles might shape the stromal microenvironment toward fibrosis.	1 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2024
• Primary Completion (Estimated): August 11, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: January 9, 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 9, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia; Leukemia, Hairy Cell
• Other Study ID Numbers: HCL-EV; PNRR-TR1-2023-12377450 (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