WAL-KU: Expression of Ku70/XRCC6 in Waldenström's Macroglobulinemia

Sponsor

Central Hospital, Nancy, France (Other)

Overall Status

Completed

CT.gov ID

NCT02640287

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Waldenström's macroglobulinemia is a rare disease whose pathophysiology remains at present poorly understood, although a recurrent mutation (L265P MYD88) has recently been described. Unlike other lymphoproliferative disorders, there is a defect in isotype switching, mechanism involving AID and NHEJ complex. Using a two-dimensional electrophoresis technology, our group showed that MW had a specific proteomic profile, and one of the differentially expressed proteins is Ku70 (encoded by XRCC6 belonging to NHEJ complex) .

The investigators purpose to explore the mechanisms of underexpression of Ku70/XRCC6 (genetic or epigenetic modification) in comparison with other lymphoid malignancies and normal B cells.

Condition or Disease	Intervention/Treatment	Phase
Waldenström Macroglobulinemia	Biological: Blood or bone marrow samples	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

55 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Expression of Ku70/XRCC6 and Others NHEJ Components in Waldenström's Macroglobulinemia in Comparison With Others B-cell Lymphoproliferative Disorders and Normal B Cells.

Study Start Date :

Feb 1, 2016

Actual Primary Completion Date :

Jun 1, 2020

Actual Study Completion Date :

Jul 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Waldenström macroglobulinemia Patients with diagnosis of Waldenström macroglobulinemia	Biological: Blood or bone marrow samples
Experimental: Others B-cell malignancies Patients with diagnosis of Chronic Lymphocytic Leukemia, Splenic Marginal Zone Lymphoma or Multiple Myeloma	Biological: Blood or bone marrow samples
Other: Healthy subjects Control healthy subjects without B-cell malignancy	Biological: Blood or bone marrow samples

Arm

Intervention/Treatment

Experimental: Waldenström macroglobulinemia

Patients with diagnosis of Waldenström macroglobulinemia

Biological: Blood or bone marrow samples

Experimental: Others B-cell malignancies

Patients with diagnosis of Chronic Lymphocytic Leukemia, Splenic Marginal Zone Lymphoma or Multiple Myeloma

Biological: Blood or bone marrow samples

Other: Healthy subjects

Control healthy subjects without B-cell malignancy

Biological: Blood or bone marrow samples

Outcome Measures

Primary Outcome Measures

Measure of ratio Ku70/XRCC6 [Baseline]
Comparing the average level of expression of Ku70 in B cells measured in patients of WM, in patients other SLP and in healthy subjects (without MW and other SLP) , matched for age ( +/- 5 years) and sex

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patient over 18 years, affiliated to the social regimen
Written consent collected

MW group :

Patient with a diagnosis of MW according to WHO criteria (based on the results of serum protein electrophoresis, bone marrow analysis with immunophenotyping, cytogenetic analysis and mutation L265P MyD88)

Other SLP :

Patient with diagnosis of Chronic Lymphocytic Leukemia, Splenic Marginal Zone Lymphoma or Multiple Myeloma

Healthy volunteers :

volunteers without blood disorders

Exclusion Criteria:

Women of childbearing age who do not have an effective means of contraception
Pregnant or nursing
Demonstration of a kappa or lambda monotype on B lymphocytes
healthy volunteer with B-cell malignancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHRU Nancy	Vandoeuvre les Nancy		France	54500

Sponsors and Collaborators

Central Hospital, Nancy, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aurore PERROT, Principal Investigator, Central Hospital, Nancy, France

ClinicalTrials.gov Identifier:

NCT02640287

Other Study ID Numbers:

2015-A01516-43

First Posted:

Dec 28, 2015

Last Update Posted:

Aug 6, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Waldenstrom Macroglobulinemia

Study Results

No Results Posted as of Aug 6, 2021