Chronic Lymphocytic LeukemiaMALYZOMA-IINCT04952974
B-cell Chronic Lymphoid Malignancies Markers
An observational study of Chronic Lymphocytic Leukemia and Marginal Zone Lymphoma, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Marginal Zone Lymphoma, Lymphoplasmacytic Lymphoma/Waldenström Macroglobulinemia
- How many people
- 420 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jun 2021to 30 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 18 years-old with of Marginal Zone Lymphoma and other B-cell chronic lymphoid malignancies
Who may be able to join
- 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
Who cannot join
- patients under guardianship or curatorship
- patients who did not gave their consent for the use of their cells and/or data
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hematology Laboratory - Strasbourg University Hospitals
Strasbourg, 67091
Laurent MAUVIEUX, MD, PhD, 33 3 88 12 75 27, laurent.mauvieux@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, 33 3 88 11 66 90, said.chayer@chru-strasbourg.fr
About this study
Official title: Study of Cell Markers of Marginal Zone Lymphoma and Other B-cell Chronic Lymphoid Malignancies
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.
Read more
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.
- Conditions
- Chronic Lymphocytic Leukemia, Marginal Zone Lymphoma, Lymphoplasmacytic Lymphoma/Waldenström Macroglobulinemia, Mantle Cell Lymphoma, Hairy Cell Leukemia, Follicular Lymphoma
- Keywords
- Chronic B-cell malignancies, Flow cytometry, Biomarkers, Statistical algorithms
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, B-Cell, Marginal Zone, Waldenstrom Macroglobulinemia, Lymphoma, Mantle-Cell, Leukemia, Hairy Cell, Lymphoma, Follicular
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective study of laboratory data from patients with B lymphoid hemopathy, mainly lymphoma in the marginal zone
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start14 Jun 2021
- Primary completion30 Jan 2023 (estimated)
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent MAUVIEUX, MD, PhD, Study director, Hematology Laboratory - Strasbourg University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952974
- Sponsor's protocol ID
- 8205
- Acronym
- MALYZOMA-II
- Status last verified
- May 2021
- First submitted
- 27 May 2021
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mauvieux L, Herbrecht R, Eischen A, Galoisy AC, Rolland D, Gervais C, Mayeur-Rousse C, Hueber-Bonnot S, Nicolae A, Fornecker LM, Goetsch T, Severac F, Bizoi R, Fabacher T, Miguet L. Artificial intelligence-based flow cytometry for the diagnosis of B-cell chronic lymphoproliferative disorders. Blood Adv. 2025 Nov 25;9(22):5880-5887. doi: 10.1182/bloodadvances.2025016424.
PubMed 41236721
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Cell Markers of Marginal Zone Lymphoma and Other B-cell Chronic Lymphoid Malignancies
- ClinicalTrials.gov ID
- NCT04952974
- Acronym / sponsor ID
- MALYZOMA-II / 8205
- Conditions
- Chronic Lymphocytic Leukemia, Marginal Zone Lymphoma, Lymphoplasmacytic Lymphoma/Waldenström Macroglobulinemia, Mantle Cell Lymphoma, Hairy Cell Leukemia, Follicular Lymphoma
- Keywords
- Chronic B-cell malignancies, Flow cytometry, Biomarkers, Statistical algorithms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 30 Jan 2023 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 7 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years-old with of Marginal Zone Lymphoma and other B-cell chronic lymphoid malignancies
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- patients under guardianship or curatorship
- patients who did not gave their consent for the use of their cells and/or data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retrospective study of laboratory data from patients with B lymphoid hemopathy, mainly lymphoma in the marginal zone
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Derived from this study: PubMed 41236721Mauvieux L, Herbrecht R, Eischen A, Galoisy AC, Rolland D, Gervais C, Mayeur-Rousse C, Hueber-Bonnot S, Nicolae A, Fornecker LM, Goetsch T, Severac F, Bizoi R, Fabacher T, Miguet L. Artificial intelligence-based flow cytometry for the diagnosis of B-cell chronic lymphoproliferative disorders. Blood Adv. 2025 Nov 25;9(22):5880-5887. doi: 10.1182/bloodadvances.2025016424.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent MAUVIEUX, MD, PhD study director
Hematology Laboratory - Strasbourg University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lymphocytic Leukemia and Marginal Zone Lymphoma, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laurent MAUVIEUX, MD, PhD (33 3 88 12 75 27, laurent.mauvieux@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective study of laboratory data from patients with B lymphoid hemopathy, mainly lymphoma in the marginal zone (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04952974, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021.