Study to Assess Disease Burden and Treatment Response in Adults with Hairy Cell Leukemia Using Blood and Bone Marrow Analysis

What this Trial Is About

Researchers are studying patients with Hairy Cell Leukemia to better understand how the mutated V600E gene in the B-raf gene relates to disease activity. This observational pilot study aims to evaluate whether the absence of this mutation after treatment can predict longer periods without needing further treatment. The study also looks at how mutation levels correspond with response duration, especially in patients who remain treatment-free for at least five years after initial therapy with purine analogues. Participants will have blood samples taken from their peripheral blood and bone marrow, along with bone marrow biopsies. These samples will be analyzed using digital droplet PCR ddPCR to measure the fractional abundance of the mutated gene allele. The study focuses on patients with confirmed Hairy Cell Leukemia who have undergone or are candidates for specific treatments, but no drug interventions are given as part of this observational study. During the study, researchers will monitor progression-free survival, time to next treatment, and correlations between mutation levels and treatment response over an average of four years. Participants will undergo regular blood and biopsy sampling to assess disease burden and mutation status. The study includes thorough molecular and clinical evaluations to better predict long-term outcomes without additional therapy.

Assessment of Disease Burden in Hairy Cell Leukemia