Venetoclax Resistance Landscape in Chronic Lymphocytic Leukemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Lymphocytic Leukemia, CLL, Progressive Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The purpose of this study is to collect medical informations and samples from refractory and/or relapsed chronic lymphocytic leukemia during or after venetoclax treatment, in order to evaluate the frequency of resistance mechanisms.
Detailed description
The purpose of this study is to collect medical informations and samples (blood, bone marrow and/or lymph node) from refractory and/or relapsed chronic lymphocytic leukemia during or after venetoclax treatment, in order to evaluate the frequency of resistance mechanisms (BCL2 mutations, over-expression of other members of the BCL2 protein family and energy metabolism changes).
Primary outcome measures
- Frequency measurement of BCL2 gene mutations [Time frame: immediately after the chronic lymphocytic leukemia progression]
Secondary outcome measures (5)
- Frequency measurement of 1q amplification [Time frame: immediately after the chronic lymphocytic leukemia progression]
- Differential expression of candidate transcripts and proteins [Time frame: immediately after the chronic lymphocytic leukemia progression]
- Correlation of resistance mechanisms with clinical staging [Time frame: immediately after the chronic lymphocytic leukemia progression]
- Correlation of resistance mechanisms with genomic chronic lymphocytic leukemia features [Time frame: immediately after the chronic lymphocytic leukemia progression]
- Progression Free Survival according to resistance mechanisms [Time frame: immediately after the chronic lymphocytic leukemia progression]
Eligibility criteria
Inclusion criteria
- Age greater than or equal to 18 years old;
- chronic lymphocytic leukemia diagnosis according to iwCLL criteria;
- refractory and/or relapsed disease during or after venetoclax treatment;
- tumor samples available.
- Relapse might be progressive chronic lymphocytic leukemia or transformation into Richter syndrome.
- Patients must be able to express their opposition to be enrolled in this study, if need be.
- Patients must be affiliated at the French Social Security system
Exclusion criteria
Patients of their legal guardians refusing to participate
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 14 centers
- CHU d'Amiens — Amiens
- CHU de Besançon — Besançon
- Hopital AVICENNE — Bobigny
- CHU clermont-ferrand — Clermont-Ferrand
- CHU de Clermont Ferrand — Clermont-Ferrand
- CHU Grenoble — Grenoble
- CHRU de Lille — Lille
- Centre LEON BERARD — Lyon
- … and 6 more centers
Identifiers
NCT: NCT05246345 · RNI 2021 GUIEZE · 2021-A00362-39