Assessment of Disease Burden in Hairy Cell Leukemia

Launched by IRCCS AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA · Jan 13, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at the impact of Hairy Cell Leukemia (HCL) on patients' lives and how the disease affects them over time. It’s a study where participants will not receive any new treatments but will be observed to better understand the burden of this condition. The goal is to gather information from those who are newly diagnosed, those who have had a relapse after treatment, or patients who have been in complete remission for at least five years.

To participate in this study, individuals must be at least 18 years old and have a confirmed diagnosis of Hairy Cell Leukemia. They should either be starting their first treatment, need help after previous treatments, or have been in remission for a long time without showing signs of the disease returning. Participants will be asked to sign a consent form and, importantly, those with another type of cancer cannot join this study. Throughout the trial, participants can expect to share their experiences and health status, helping researchers gain valuable insights into living with Hairy Cell Leukemia.

Gender

ALL

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.