MALYZOMA-II: B-cell Chronic Lymphoid Malignancies Markers

• Sponsor: University Hospital, Strasbourg, France (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04952974
• Collaborator: (none)
• Enrollment: 420
• Location: 1
• Anticipated Duration (Months): 21.5
• Patients Per Site Per Month: 19.5

Study Details

Study Description

Brief Summary

Lymphoid chronic B-cell malignancies are frequent pathologies that affect adults, with a very variable prognosis and treatment (some of them can remain untreated). The diagnosis of these malignancies relies on the study of the morphology of tumoral cells and the expression by these cells of several markers, mainly via a technical approach called flow cytometry. Because the markers currently used remain imperfect, additional ones are needed for an accurate diagnosis that affect both prognosis and treatment.

In addition, because numerous markers are used at the diagnosis, there is a need of tools that synthetize the multi-dimensional structure of the data obtained.

The primary purpose of this study is to detect new markers that can be of help for the diagnosis of Marginal Zone Lymphoma and other B-cell chronic lymphoid malignancies.

The secondary purpose of this study is to obtain a statistical algorithm that allow a good prediction of the different sub-types of chronic B-cell malignancies mainly using the results of flow cytometry.

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia; Marginal Zone Lymphoma; Lymphoplasmacytic Lymphoma/Waldenström Macroglobulinemia; Mantle Cell Lymphoma; Hairy Cell Leukemia; Follicular Lymphoma

Study Design

• Study Type: Observational
• Anticipated Enrollment: 420 participants
• Observational Model: Case-Only
• Time Perspective: Other
• Official Title: Study of Cell Markers of Marginal Zone Lymphoma and Other B-cell Chronic Lymphoid Malignancies
• Actual Study Start Date: Jun 14, 2021
• Anticipated Primary Completion Date: Jan 30, 2023
• Anticipated Study Completion Date: Mar 30, 2023

Outcome Measures

Primary Outcome Measures

1. Retrospective study of laboratory data from patients with B lymphoid hemopathy, mainly lymphoma in the marginal zone [2 years]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• patients over 18 years-old with of Marginal Zone Lymphoma and other B-cell chronic lymphoid malignancies

• patients that gave their informed consent for the conservation of blood or bone marrow cells (primary objective 1)

• patients that gave their informed consent for the retrospective use of their clinical and biological data

Exclusion Criteria:

• patients under guardianship or curatorship

• patients who did not gave their consent for the use of their cells and/or data

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hematology Laboratory - Strasbourg University Hospitals	Strasbourg		France	67091

Sponsors and Collaborators

• University Hospital, Strasbourg, France

Investigators

• Study Director: Laurent MAUVIEUX, MD, PhD, Hematology Laboratory - Strasbourg University Hospitals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Strasbourg, France
• ClinicalTrials.gov Identifier: NCT04952974
• Other Study ID Numbers: 8205
• First Posted: Jul 7, 2021
• Last Update Posted: Jul 7, 2021
• Last Verified: May 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Strasbourg, France: Chronic B-cell malignancies; Flow cytometry; Biomarkers; Statistical algorithms
• Additional relevant MeSH terms: Lymphoma; Leukemia; Neoplasms; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Mantle-Cell; Lymphoma, B-Cell, Marginal Zone; Waldenstrom Macroglobulinemia; Leukemia, Hairy Cell

Study Results

No Results Posted as of Jul 7, 2021