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

Primary Purpose

Waldenstrom's Disease, Waldenstrom Macroglobulinemia

Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
bone marrow sample
blood sample
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Waldenstrom's Disease focused on measuring Waldenstrom's Disease, Waldenstrom Macroglobulinemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Amiens

Outcomes

Primary Outcome Measures

association between circulating tumoral DNA detection and progression-free survival
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.

Secondary Outcome Measures

Full Information

First Posted
May 17, 2021
Last Updated
June 20, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
Centre Henri Becquerel, University Hospital, Caen, University Hospital, Lille, Centre Hospitalier de Lens
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1. Study Identification

Unique Protocol Identification Number
NCT04893564
Brief Title
Prognostic Value of Circulating Tumoral DNA After the First 6 Months of Treatment in Patients With Waldenström Macroglobulinemia
Acronym
SLP-rares
Official Title
Prognostic Value of Circulating Tumoral DNA After the First 6 Months of Treatment in Patients With Waldenström Macroglobulinemia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Withdrawn
Why Stopped
no participants enrolled
Study Start Date
May 14, 2021 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
Centre Henri Becquerel, University Hospital, Caen, University Hospital, Lille, Centre Hospitalier de Lens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Waldenstrom's Disease, Waldenstrom Macroglobulinemia
Keywords
Waldenstrom's Disease, Waldenstrom Macroglobulinemia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
bone marrow sample
Intervention Description
8 to 13 ml bone marrow sample for frozen storage within one of the 5 certified biobank of the canceropole area.
Intervention Type
Biological
Intervention Name(s)
blood sample
Intervention Description
20 ml blood sample for frozen storage within one of the 5 certified biobank of the canceropole area.
Primary Outcome Measure Information:
Title
association between circulating tumoral DNA detection and progression-free survival
Description
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.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80480
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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