Assessment of Disease Burden in Hairy Cell Leukemia

NCT ID: NCT06781515

Last Updated: 2025-01-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-31
• Study Completion Date: 2025-11-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

HCL, B-raf V600E-mutated patients

For each patient only pheripheral and medullary blood sample and medullary biospy will be collected

Group Type: OTHER

Peripheral and BM blood sample

Intervention Type: OTHER

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

Interventions

Peripheral and BM blood sample

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pier Luigi Zinzani, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

IRCCS Azienda Ospedaliero - Universitaria di Bologna

Bologna, Bologna, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Pier Luigi Zinzani, MD

Role: CONTACT

pierluigi.zinzani@unibo.it

+390512143680

Alessandro Broccoli, MD

Role: CONTACT

Alessandro.broccoli@studio.unibo.it

+39 0512143680

Facility Contacts

Pier Luigi Zinzani, MD

Role: primary

pierluigi.zinzani@unibo.it

+390512143680

Alessandro Broccoli, MD

Role: backup

Alessandro.broccoli@studio.unibo.it

+39 0512143680

Pier Luigi Zinzani, MD

Role: backup

Other Identifiers

BRAF

Identifier Type: -

Identifier Source: org_study_id