Measuring circulating tumor DNA to predict outcomes after six months of treatment in Waldenström macroglobulinemia
Prognostic Value of Circulating Tumoral DNA After the First 6 Months of Treatment in Patients With Waldenström Macroglobulinemia
This will test whether measuring circulating tumor DNA after six months of treatment helps predict outcomes for people with Waldenström macroglobulinemia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Trial ID | NCT04893564 on ClinicalTrials.gov |
What this trial studies
People with Waldenström macroglobulinemia who need first-line or later therapy and are followed at participating centers will provide blood and bone marrow samples, including a sample after six months of treatment. Investigators will analyze circulating tumor DNA for common driver mutations (for example MYD88 and CXCR4) and quantify residual tumor DNA levels. ctDNA measurements and mutation dynamics will be compared with clinical response, progression, and the need for additional therapy. The aim is to see if ctDNA at six months adds prognostic information beyond standard clinical and laboratory measures.
Who should consider this trial
Good fit: Ideal candidates are people diagnosed with Waldenström macroglobulinemia who require systemic therapy, are followed at participating centers in the North-Western region of France, and can give informed consent.
Not a fit: Patients with other concurrent B‑cell malignancies, histologic transformation, or those without detectable tumor DNA mutations are less likely to gain direct benefit from the test.
Why it matters
Potential benefit: If successful, this could allow earlier identification of patients at higher risk of relapse so clinicians can tailor follow-up and treatment more precisely.
How similar studies have performed: Prior work has shown ctDNA can detect MYD88 mutations and track disease in WM and other lymphomas, but using ctDNA specifically at six months as a prognostic marker remains relatively novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient with WM according to diagnostic criteria * Patients with WM followed in one of the centre of North-Western region. * Patients requiring first-line or subsequent-line therapy * Patients agreement for giving informed consent. * Social insurance system affiliation Exclusion Criteria: * Patients with another chronic B-cell malignancy * patients with other lymphoplasmacytic proliferations * patients with marginal zone lymphoma. * Patients with WM and histologic transformation * Absence of informed consent
Where this trial is running
Amiens
- CHU Amiens — Amiens, France (Recruiting)
Study contacts
- Study coordinator: Pierre MOREL, MD
- Email: morel.pierre@chu-amiens.fr
- Phone: 03.22.45.54.19
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.