Brief Title
Prognostic Value of Circulating Tumoral DNA After the First 6 Months of Treatment in Patients With Waldenström Macroglobulinemia
Official Title
Prognostic Value of Circulating Tumoral DNA After the First 6 Months of Treatment in Patients With Waldenström Macroglobulinemia
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.
Study Type
Interventional
Primary Outcome
association between circulating tumoral DNA detection and progression-free survival
Condition
Waldenstrom's Disease
Intervention
bone marrow sample
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
90
Start Date
May 14, 2021
Completion Date
May 2024
Primary Completion Date
May 2024
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, 03.22.45.54.19, [email protected]
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT04893564
Organization ID
PI2019_843_0024
Responsible Party
Sponsor
Study Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
Centre Henri Becquerel
Study Sponsor
, ,
Verification Date
February 2023