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French Observational Study of Patients With Chronic Lymphocytic Leukemia Or Small Lymphocytic Lymphoma in Real-World Settings

NCT05590702 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2025-12-03

No results posted yet for this study

Summary

Chronic lymphocytic leukemia (CLL) is the most frequent form of leukemia in the Western World. The disease is characterized by the accumulation and proliferation of mature, monoclonal, CD5+ B-cells with specific immunophenotype in the peripheral blood (above 5x109/L), bone marrow and secondary lymphoid organs. Small lymphocytic leukemia (SLL) is characterized by similar tumor cells but without increased lymphocyte count. The management of these patients have considerably changed over the last decade. Indeed, beyond chemo-immunotherapy, multiple targeted therapies have been approved on the basis of phase 2 and randomized phase 3 clinical trials and have subsequently been used in daily practice. The management of patients with SLL is similar to that of those with CLL. In addition to therapeutic advances, the advent of new sequencing technologies has also identified CLL genetic features that are now being incorporated in patient routine evaluation.

We here propose to set a large-scale prospective and non-interventional study including patients with symptomatic CLL/SLL with the aim to evaluate the real-world clinical management of these patients and to identify the impact of treatments and therapeutic trajectories on long-term outcome.

Conditions

  • CLL/SLL

Interventions

DRUG

First line therapy

Patient with CLL or SLL requiring a therapeutic strategy according to iwCLL criteria or investigator evaluation will be identified in MCM (multidisciplinary collegial meeting). Patients will be treated and managed according to the decision of their physicians and the related MDM. No treatment plan is recommended in the setting of this non-interventional study.

Sponsors & Collaborators

  • AbbVie

    collaborator INDUSTRY

  • AstraZeneca

    collaborator INDUSTRY

  • BeiGene

    collaborator INDUSTRY

  • Janssen-Cilag Ltd.

    collaborator INDUSTRY

  • French Innovative Leukemia Organisation

    lead OTHER

Principal Investigators

  • Romain GUIEZE · French Innovative Leukemia Organisation

  • Xavier TROUSSARD · French Innovative Leukemia Organisation

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-11
Primary Completion
2025-04-18
Completion
2032-12-01

Countries

  • France

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05590702 on ClinicalTrials.gov