Assessment of Disease Burden in Hairy Cell Leukemia

NCT06781515 | Recruiting

• 1 other identifier: BRAF
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hairy Cell Leukemia

Outcome Measures

Primary Outcomes (3)

• Progression Free Survival (PFS)

  Progression Free Survival (PFS)

  through study completion, an average of 4 years

• Time to next treatment

  Time to next treatment

  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

  through study completion, an average of 4 years

Secondary Outcomes (1)

• mutational pattern of B-raf i

  through study completion, an average of 4 years

Study Arms (1)

HCL, B-raf V600E-mutated patients

OTHER

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

Other: Peripheral and BM blood sample

Interventions

Peripheral and BM blood sample OTHER

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

HCL, B-raf V600E-mutated patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of HCL patients:
• newly diagnosed and candidates for first-line cytoreductive treatment with analogues purines or
• 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
• 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).
• Age ≥ 18 years at enrollment
• Signature of written informed consent

You may not qualify if:

• \. Concomitant second malignancy.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero - Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Leukemia, Hairy Cell

Condition Hierarchy (Ancestors)

Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Pier Luigi Zinzani, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pier Luigi Zinzani, MD

CONTACT

+390512143680; pierluigi.zinzani@unibo.it

Alessandro Broccoli, MD

CONTACT

+39 0512143680; Alessandro.broccoli@studio.unibo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: January 17, 2025
• Study Start: January 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: January 17, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)