Measuring circulating tumor DNA to predict outcomes after six months of treatment in Waldenström macroglobulinemia
Official title: Prognostic Value of Circulating Tumoral DNA After the First 6 Months of Treatment in Patients With Waldenström Macroglobulinemia
Run by Centre Hospitalier Universitaire, Amiens · NCT04893564 · Data updated 2026-11-12
This will test whether measuring circulating tumor DNA after six months of treatment helps predict outcomes for people with Waldenström macroglobulinemia.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Status | Recruiting |
| Started | May 16, 2022 |
| Main results expected | July 2027 |
| Study ends | July 2028 |
| Registry record updated | September 9, 2025 |
| Trial ID | NCT04893564 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
CHU Amiens
Amiens, France Recruiting
Study contacts
- Study coordinator: Pierre MOREL, MD
- Email: morel.pierre@chu-amiens.fr
- Phone: 03.22.45.54.19
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.