Prognostic Value of Circulating Tumoral DNA After the First 6 Months of Treatment in Patients With Waldenström Macroglobulinemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: bone marrow sample, blood sample.
- Who it may be relevant to
- Registry conditions: Waldenstrom's Disease, Waldenstrom Macroglobulinemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Biological bone marrow sample
8 to 13 ml bone marrow sample for frozen storage within one of the 5 certified biobank of the canceropole area. - Biological blood sample
20 ml blood sample for frozen storage within one of the 5 certified biobank of the canceropole area.
Primary outcome measures
- association between circulating tumoral DNA detection and progression-free survival [Time frame: 3 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- CHU Amiens — Amiens
Identifiers
NCT: NCT04893564 · PI2019_843_0024