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SLP-rares: Prognostic Value of Circulating Tumoral DNA After the First 6 Months of Treatment in Patients With Waldenström Macroglobulinemia

Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Recruiting
CT.gov ID
NCT04893564
Collaborator
Centre Henri Becquerel (Other), University Hospital, Caen (Other), University Hospital, Lille (Other), Centre Hospitalier de Lens (Other)
90
Enrollment
1
Location
35.6
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: bone marrow sample
  • Biological: blood sample
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Prognostic Value of Circulating Tumoral DNA After the First 6 Months of Treatment in Patients With Waldenström Macroglobulinemia
Actual Study Start Date :
May 14, 2021
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Outcome Measures

Primary Outcome Measures

  1. association between circulating tumoral DNA detection and progression-free survival [3 years]

    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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Amiens Amiens France 80480

Sponsors and Collaborators

  • Centre Hospitalier Universitaire, Amiens
  • Centre Henri Becquerel
  • University Hospital, Caen
  • University Hospital, Lille
  • Centre Hospitalier de Lens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT04893564
Other Study ID Numbers:
  • PI2019_843_0024
First Posted:
May 19, 2021
Last Update Posted:
May 19, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire, Amiens
Waldenstrom's Disease
Waldenstrom Macroglobulinemia
Additional relevant MeSH terms:
Waldenstrom Macroglobulinemia

Study Results

No Results Posted as of May 19, 2021