Assessment of Disease Burden in Hairy Cell Leukemia

Last updated: January 13, 2025
Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Overall Status: Active - Recruiting

Phase

N/A

Condition

Leukemia

Leukemia (Pediatric)

Hematologic Cancer

Treatment

Peripheral and BM blood sample

Clinical Study ID

NCT06781515
BRAF
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Histologically confirmed diagnosis of HCL patients:

  2. newly diagnosed and candidates for first-line cytoreductive treatment withanalogues purines or

  3. in relapse after a previous line of treatment, with indication for rescuetherapy (repetition of a purine analogue; use of targeted or innovative drugs),except splenectomy or

  4. in CR for at least 5 years after a first line of treatment, in the absence ofclinical alterations indicative of a state of hematological relapse, or in anycase in the absence of an indication for a new line of cytoreductive therapy (time-to-next treatment exceeding 5 years).

  5. Age ≥ 18 years at enrollment

  6. Signature of written informed consent

Exclusion

Exclusion Criteria:

  1. Concomitant second malignancy.

Study Design

Total Participants: 45
Treatment Group(s): 1
Primary Treatment: Peripheral and BM blood sample
Phase:
Study Start date:
January 01, 2025
Estimated Completion Date:
November 30, 2025

Study 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.

Connect with a study center

  • IRCCS Azienda Ospedaliero - Universitaria di Bologna

    Bologna, 40138
    Italy

    Active - Recruiting

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