Prognostic Analyses on a Validation Series of Patients With Waldenström's Disease
Waldenström's macroglobulinemia (WM) is defined by the association of bone marrow lymphoplasmocytic infiltration and monoclonal immunoglobulin M (IgM). A mutation in the MYD88 gene is found in up to 90% of patients, and a mutation in the CXCR4 gene in approximately one third of patients. Treatment should be initiated i
| Condition(s) | Waldenstrom's Disease, Prognostic Index |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | Waldenström's macroglobulinemia (WM) is defined by the association of bone marrow lymphoplasmocytic infiltration and monoclonal immunoglobulin M (IgM). A mutation in the MYD88 gene is found in up to 90% of patients, and a mutation in the CXCR4 gene in approximately one third of patients. Treatment should be initiated in cases of cytopenia, bulky disease or when the physicochemical or immunological properties of IgM explain the occurrence of amyloidosis, cryoglobulin, neurological manifestations, or hyperviscosity syndrome (due to the presence of a large amount of IgM). However, approximately 30% of patients are diagnosed without any symptom and therefore they do not meet the criteria for initiating treatment. At the time of initiation of the first treatment, the prognosis is usually estima |
| Who can participate | Inclusion Criteria: * Patient with WM, fulfilling the diagnostic criteria defined at the 2nd Workshop on WM. * Patient in whom follow-up is available until at least 01/01/2020. Each participating center should not enroll more 10% of patients lost to follow-up. * Patient for whom a minimum annual follow-up is planned until 2024. * Having given their consent for this study Exclusion Criteria: * Patient with other chronic lymphoid malignancy. Special attention will be paid to exclude other lymphoplasmacytic proliferations, especially marginal zone lymphoma. * Patient with histological transformation in a diffuse large B-cell lymphoma or any other lymphoma at the time of the initiation of the 1st treatment. * No consent for this study. |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | French Innovative Leukemia Organisation |
| Locations | Amiens, France; Angers, France; Bordeaux, France; Clermont-Ferrand, France; Le Mans, France; Lens, France (+9 more sites) |
| Start date | 2023-08-11 |
| NCT ID | NCT05911802 |
| Official listing | https://clinicaltrials.gov/study/NCT05911802 |