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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06764524

Enrollment

Registered

2025-01-08

Start date

2024-12-05

Completion date

2027-12-04

Last updated

2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hairy Cell Leukemia (HCL)

Brief 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)

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Extracellular vesicle characterization	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.

Secondary

Measure	Time frame	Description
Extracellular vesicles' functions and biomarker validation	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.

Countries

Italy

Contacts

Primary ContactLucia Catani, PhD

lucia.catani@unibo.it+390512143837

Outcome results