Clinical trial · Observational
French Observational Study of Patients With Chronic Lymphocytic Leukemia Or Small Lymphocytic Lymphoma in Real-World Settings
French Observational Study of Patients With Chronic Lymphocytic Leukemia Or Small Lymphocytic Lymphoma in Real-World Settings. A FILO Study.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CLL/SLL | Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| First line therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Representativity of CLL therapies and sequences across
- timeFrame
- 7-year period of time
- description
- Number of patients who received a particular type of therapy (chemo-immunotherapy, kinase inhibitors targeting the B-cell receptor signaling, B-cell lymphoma 2 inhibitor) at baseline and in relapse and in which sequence
Secondary outcomes (2)
- measure
- Overall survival
- timeFrame
- 7 years
- description
- registering cause of death focusing on CLL, infection, Richter's syndrome, immune disorders and secondary malignancies
- measure
- Long-term toxicity
- timeFrame
- 7 years
- description
- infection requiring hospitalization, secondary malignancies, cardiac and vascular events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18-year old * CLL or SLL requiring a therapeutic strategy according to iwCLL criteria or investigator evaluation * Patient requiring therapy for immune events (autoimmune Thrombocytopenia and autoimmune hemolytic anemia) are eligible * Patients who have been informed verbally and in writing about this study, and who do not object to their data being electronically processed or subjected to data quality control * All consecutive patients for whom a discussion in the setting of local or regional multidisciplinary collegial meeting (in french : réunion de concertation pluridisciplinaire / RCP) has retained the need for starting a therapeutic strategy (curative or palliative) * Patients with untreated or previously treated CLL/SLL are both eligible * Patients enrolled in a clinical trial can be included in this non-interventional cohort study * Patients requiring therapy for CLL/SLL-associated immune events only are also eligible Exclusion Criteria: * Patients with no need of therapy * Patients with asymptomatic Binet A CLL * Patient with Richter's syndrome at inclusion * Patient requiring immunoglobulin substitution (with no need of a more specific therapy)
References
Publications (0)
Data not yet available