An interventional study of Peripheral and BM blood sample in Hairy Cell Leukemia, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-17.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Not applicable, Interventional, and Prevention
Drug-free, single-center, prospective observational pilot study in hairy Cell Leukemia patients
The V600E gene lesion of B-raf, specific and almost always present in patients with hairy cell leukemia, correlates with the presence of neoplastic cells, therefore of active disease. The measurement of the fractional abundance of the mutated gene, by ddPCR, could therefore constitute a method of molecular assessment of the minimal residual disease. In addition, the values of fractional abundance (FA) of the mutated allele obtained can be integrated coherently in patients' clinical context, along with their PB counts and BM findings.
Primary objective Verify whether the absence of mutation at the end of treatment, indicative of a state of complete molecular response to therapy, can represent a predictor of long treatment-free survival.
Secondary objectives Verify the association between the absence of mutation and the duration of response in patients who do not need treatment for at least 5 years after only one treatment with purine analogues (cladribine and pentostatin) and judged in CR according to current criteria.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's planned enrollment of 45 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 493 studies on the registry; 273 are open to participants now.
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Histologically confirmed diagnosis of HCL patients:
Exclusion Criteria:
For each patient only pheripheral and medullary blood sample and medullary biospy will be collected
Other: Peripheral and BM blood sample
Peripheral and BM blood samples will be analyzed with the ddPCR method
Progression Free Survival (PFS)
Progression Free Survival (PFS)
Time frame: through study completion, an average of 4 years
Time to next treatment
Time to next treatment
Time frame: through study completion, an average of 4 years
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.
Correlation between the share of mutated allele (fractional abundance) with the response
Time frame: through study completion, an average of 4 years
mutational pattern of B-raf i
Evaluation of the mutational pattern of B-raf in patients with HCL in long hematological response
Time frame: through study completion, an average of 4 years
Plan to share: No
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IRCCS Azienda Ospedaliero-Universitaria di Bologna