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

NCT04893564 | Recruiting

• 1 other identifier: PI2019_843_0024
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Waldenstrom's Disease; Waldenstrom Macroglobulinemia

Keywords

Waldenstrom's Disease; Waldenstrom Macroglobulinemia

Outcome Measures

Primary Outcomes (1)

• 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.

  3 years

Interventions

bone marrow sample BIOLOGICAL

8 to 13 ml bone marrow sample for frozen storage within one of the 5 certified biobank of the canceropole area.

blood sample BIOLOGICAL

20 ml blood sample for frozen storage within one of the 5 certified biobank of the canceropole area.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

CHU Amiens

Amiens, 80480, France

RECRUITING

MeSH Terms

Conditions

Waldenstrom Macroglobulinemia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Pierre MOREL, MD

CONTACT

03.22.45.54.19; morel.pierre@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 19, 2021
• Study Start: May 16, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)