Assessing disease burden in patients with hairy cell leukemia
Assessment of Disease Burden in Hairy Cell Leukemia
This study is trying to see if checking for a specific gene mutation in patients with hairy cell leukemia can help predict how long they can stay healthy without treatment after their initial therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna, Bologna) |
| Trial ID | NCT06781515 on ClinicalTrials.gov |
What this trial studies
This is a drug-free, single-center, prospective observational pilot study focusing on patients with hairy cell leukemia (HCL). The study aims to measure the fractional abundance of the V600E B-raf gene mutation using digital droplet PCR (ddPCR) to assess minimal residual disease. It will evaluate whether the absence of this mutation at the end of treatment can predict long-term treatment-free survival. Additionally, the study will explore the relationship between the absence of mutation and the duration of response in patients who have not required treatment for at least five years after initial therapy.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of hairy cell leukemia, either newly diagnosed or in remission for at least five years.
Not a fit: Patients with a concurrent second malignancy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new method for predicting long-term survival in hairy cell leukemia patients.
How similar studies have performed: While this approach is novel in the context of hairy cell leukemia, similar methodologies have shown promise in other hematological malignancies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bologna, Bologna
- IRCCS Azienda Ospedaliero - Universitaria di Bologna — Bologna, Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Pier Luigi Zinzani, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Pier Luigi Zinzani, MD
- Email: pierluigi.zinzani@unibo.it
- Phone: +390512143680
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.