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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire, Amiens

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients with another chronic B-cell malignancy

patients with other lymphoplasmacytic proliferations

patients with marginal zone lymphoma.

Patients with WM and histologic transformation

Trial design

Design model

Single group

Treatments tested in this trial

  • bone marrow sample

    Biological/Vaccine

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

  • blood sample

    Biological/Vaccine

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

Treatment groups

No treatment groups listed

Trial outcomes

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.

Time frame
3 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Universitaire, Amiens

Lead sponsor

Centre Henri Becquerel

Collaborator

University Hospital, Caen

Collaborator

University Hospital, Lille

Collaborator

Centre Hospitalier de Lens

Collaborator