Clinical trial · Observational
Determinants of the Response to BTK Degraders (BTKd) in Chronic Lymphocytic Leukemia
NCT07099443CI-TRIAL-00117231REBELLErecruitingClinicalTrials.gov clinicaltrialsProvenance
- 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)
The aim of the REBELLE cohort - bio-collection is to collect samples from patients with Chronic Lymphocytic Leukemia candidates or those exposed to BTK degraders to evaluate the mechanisms of resistance to these new molecules. To do this, an additional blood or bone marrow sample to those planned in the context of patient care or a residual lymph node biopsy sample will be collected after signing consent.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BTK Degraders | — | UNRESOLVED | — |
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-Interventional Sample Collection and Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Chronic Lymphocytic Leukemia candidates or those exposed to BTKd
- description
- Collection of additional samples of blood and bone marrow or residual lymph node biopsy at the time of inclusion (for diagnosis or relapse), month 6 and relapse.
- interventionNames
- Other: Non-Interventional Sample Collection and Analysis
Primary outcomes (1)
- measure
- Characterization of resistance mechanisms to CLL patients candidates or exposed to BTKd.
- timeFrame
- Up to 5 years after inclusion
- description
- The primary outcome is the in-depth characterization of tumor cells and their microenvironment in CLL patients candidates or exposed to BTKd. Analyses will be performed using cellular biology (e.g., flow cytometry), molecular biology (e.g., RNA sequencing), and bioinformatics (e.g., deconvolution). Functional studies include the development of preclinical ex vivo models (2D/3D culture) and gene editing of primary cells using CRISPR/Cas9 technology, based on the expertise of Team 11 at CRCI²NA. The study will include 60 patients over a 9-year enrollment period. Each participant will be followed for 5 years, resulting in a total study duration of 14 years.
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient with CLL candidates ou exposed to BTKd * Patient who has provided informed consent to participate in the study. * Patient covered by a social security health insurance plan Exclusion Criteria: * Minor patients. * Adults under guardianship. * Protected persons.
References
Publications (0)
Data not yet available
No reference posted for this study.