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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

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)

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

WHO2022-defined diagnosis of Hairy Cell Leukemia.

age ≥18 years.

signed informed consent.

age ≥18 years.

Disqualifiers

None

Trial 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.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
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.

Time frame
2 years

Other outcomes

Sponsors and contacts

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