NCT06781515

Assessment of Disease Burden in Hairy Cell Leukemia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Hairy Cell Leukemia

Interventions

Type	Name	Description
OTHER	Peripheral and BM blood sample	Peripheral and BM blood samples will be analyzed with the ddPCR method

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2025-01-17
• Last updated: 2025-01-17

Locations

1 site across 1 country: Italy