Chronic Lymphocytic Leukemia, CLL, Progressive Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia, Relapsed Chronic Lymphocytic Leukemia
Conditions
Keywords
Venetoclax, Venetoclax resistance, Resistance mechanism
Brief summary
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).
Interventions
None listed
Sponsors
University Hospital, Clermont-Ferrand
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency measurement of BCL2 gene mutations | immediately after the chronic lymphocytic leukemia progression | Frequency measurement of BCL2 gene mutations in a cohort of refractory and/or relapsed chronic lymphocytic leukemia during or after venetoclax therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency measurement of 1q amplification | immediately after the chronic lymphocytic leukemia progression | Frequency measurement of 1q amplification in a cohort of refractory and/or relapsed chronic lymphocytic leukemia during or after venetoclax therapy |
| Differential expression of candidate transcripts and proteins | immediately after the chronic lymphocytic leukemia progression | Differential expression of candidate transcripts and proteins (BCL2 protein family, AMP signaling pathway, energy metabolism) in a cohort of refractory and/or relapsed chronic lymphocytic leukemia during or after venetoclax therapy |
| Correlation of resistance mechanisms with clinical staging | immediately after the chronic lymphocytic leukemia progression | Correlation of resistance mechanisms (BCL2 mutation and 1q amplification) with clinical staging, in a cohort of refractory and/or relapsed chronic lymphocytic leukemia during or after venetoclax therapy |
| Correlation of resistance mechanisms with genomic chronic lymphocytic leukemia features | immediately after the chronic lymphocytic leukemia progression | Correlation of resistance mechanisms (BCL2 mutation and 1q amplification) with genomic chronic lymphocytic leukemia features, in a cohort of refractory and/or relapsed chronic lymphocytic leukemia during or after venetoclax therapy |
| Progression Free Survival according to resistance mechanisms | immediately after the chronic lymphocytic leukemia progression | Progression Free Survival according to resistance mechanisms (BCL2 mutation and 1q amplification), in a cohort of refractory and/or relapsed chronic lymphocytic leukemia during or after venetoclax therapy |
Countries
France
Contacts
Primary ContactLise Laclautre
Outcome results
None listed