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Clinical Trials in Italy / NCT06781515
Recruiting Not applicable

Assessment of Disease Burden in Hairy Cell Leukemia

NCT06781515 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Phase
Not applicable
Started
2025-01
Last updated
2025-01-17

Condition(s) studied

Hairy Cell Leukemia

Investigational drug(s) / intervention(s)

Peripheral and BM blood sample

Peripheral and BM blood sample: Peripheral and BM blood samples will be analyzed with the ddPCR method

Study summary

Drug-free, single-center, prospective observational pilot study in hairy Cell Leukemia patients

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Histologically confirmed diagnosis of HCL patients: 1. newly diagnosed and candidates for first-line cytoreductive treatment with analogues purines or 2. in relapse after a previous line of treatment, with indication for rescue therapy (repetition of a purine analogue; use of targeted or innovative drugs), except splenectomy or 3. in CR for at least 5 years after a first line of treatment, in the absence of clinical alterations indicative of a state of hematological relapse, or in any case in the absence of an indication for a new line of cytoreductive therapy (time-to-next treatment exceeding 5 years). 2. Age ≥ 18 years at enrollment 3. Signature of written informed consent Exclusion Criteria: 1\. Concomitant second malignancy.

Primary outcome measure(s)

  • Progression Free Survival (PFS) — through study completion, an average of 4 years
    Progression Free Survival (PFS)
  • Time to next treatment — through study completion, an average of 4 years
    Time to next treatment
  • Correlation between the share of mutated allele (fractional abundance) with the response to the treatment.Correlation between the share of mutated allele (fractional abundance) with the response to the treatment. — through study completion, an average of 4 years
    Correlation between the share of mutated allele (fractional abundance) with the response

Trial sites (1)

FacilityCityRegionStatus
IRCCS Azienda Ospedaliero - Universitaria di Bologna Bologna Bologna Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06781515 on ClinicalTrials.gov ↗ ← All trials in Italy