RecruitingNCT07099443

Determinants of the Response to BTK Degraders (BTKd) in Double Refractory CLL

Determinants of the Response to BTK Degraders (BTKd) in Double Refractory Chronic Lymphocytic Leukemia (CLL)


Sponsor

Nantes University Hospital

Enrollment

60 participants

Start Date

Oct 9, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

The aim of the REBELLE cohort - bio-collection is to collect samples from patients with Chronic Lymphocytic Leukemia (CLL), to facilitate access for the National Institute of Health and Medical Research (INSERM) to patients with double-refractory CLL. 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. These samples will first be sent to the Filothèque for temporary storage, and will then be transferred to CRCI²NA (Nantes - Angers Cancer and Immunology Research Center) for analysis with the aim of studying the mechanisms of resistance and response to BTK degraders (BTKd).


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • Patient with confirmed double refractory CLL to both BTKi and BCL-2i, defined as:
  • Any patient who has received both a BTKi and a BCL-2i, regardless of treatment regimen, and has shown clinical progression either during treatment with both BTKi and BCL-2i, or within 36 months after stopping BCL-2i.
  • Any patient identified with known biological resistance mutations to BTKi or BCL-2i, regardless of clinical progression.
  • Patient who has provided informed consent to participate in the study.
  • Patient covered by a social security health insurance plan

Exclusion Criteria3

  • Minor patients.
  • Adults under guardianship.
  • Protected persons.

Interventions

OTHERNon-Interventional Sample Collection and Analysis

This study is observational. Biological samples are collected as part of standard care or for research purposes and analyzed to characterize resistance mechanisms. No treatment or intervention is administered as part of the study protocol.


Locations(14)

CHU de Angers

Angers, France

CHU de Bordeaux

Bordeaux, France

Institut Bergonié

Bordeaux, France

CHU de Clermont-Ferrand

Clermont-Ferrand, France

CHD Vendée

La Roche-sur-Yon, France

Centre Léon Bernard

Lyon, France

Institut Paoli-Calmettes (Marseille)

Marseille, France

CHU de Montpellier

Montpellier, France

CH Régional Universitaire de Nancy

Nancy, France

University Hospital

Nantes, France

Hôpital Avicenne (AP-HP)

Paris, France

Hôpital Universitaire Pitié Salpêtrière de Paris

Paris, France

CHU de Poitiers

Poitiers, France

Centre Henri-Becquerel de Rouen

Rouen, France

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NCT07099443


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