NCT04893564 Prognostic Value of Circulating Tumoral DNA After the First 6 Months of Treatment in Patients With Waldenström Macroglobulinemia
| NCT ID | NCT04893564 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire, Amiens |
| Condition | Waldenstrom's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2022-05-16 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2022-05-16 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Waldenström Macroglobulinemia (WM) is defined by a bone marrow lymphoplasmacytic infiltration and the presence of a monoclonal immunoglobulin M (IgM) in blood. This chronic lymphoproliferative disorder requires treatment only in case of symptoms, according to accurate criteria described during the second Workshop on WM i.e. in case of cytopenia, bulky organomegaly, immunological or physicochemical consequences of the presence of IgM in circulating blood. A MYD88 mutation, typically a MYD88(L265P), is found in 90% of WM patients. Other gene abnormalities have been observed, the most frequent is a mutation in the CXCR4 gene. Overall, gene mutations in WM involve only a limited number of signalling pathways, yielding the activation of NFkB, namely : the TLR and MYD88 pathway (with an activation of NFkB and BTK in case of MYD88(L265P) mutation), the BCR pathway (involving btk and associated with activations of both NFkB, and erk akt pathway) and the CXCR4 pathway (CXCR4 is a receptor of CXCL12, it is also associated with activations of ERK/MAPK and PI3K). Abnormalities of some of genes, such as TP53, of the expression of the protein CXCL13 and genes involved in the interleukin 6 secretion have been associated with some clinical characteristics. The purpose of this project is to define the prognostic role of the detection of circulating tumoral DNA (ctDNA) at the end of treatment for the progression/relapse risk within the first 3 years after the first 6 months of treatment.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04893564 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Waldenstrom's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04893564 currently recruiting?
Yes, NCT04893564 is actively recruiting participants. Contact the research team at morel.pierre@chu-amiens.fr for enrollment information.
Where is the NCT04893564 trial being conducted?
This trial is being conducted at Amiens, France.
Who is sponsoring the NCT04893564 clinical trial?
NCT04893564 is sponsored by Centre Hospitalier Universitaire, Amiens. The trial plans to enroll 90 participants.