Clinical trial NCT05246345: Venetoclax Resistance Landscape in Chronic Lymphocytic Leukemia
Official title: Venetoclax Resistance Landscape in Chronic Lymphocytic Leukemia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Lymphocytic Leukemia
CLL
Progressive Chronic Lymphocytic Leukemia
Refractory Chronic Lymphocytic Leukemia
Relapsed Chronic Lymphocytic Leukemia
Keywords: Venetoclax
Venetoclax resistance
Resistance mechanism
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic lymphocytic leukemia diagnosis according to iwCLL criteria and who are refractory and/or relapsed disease during or after venetoclax treatment; tumor samples available.

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).

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

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Primary outcomes:
measure: Frequency measurement of BCL2 gene mutations
timeFrame: immediately after the chronic lymphocytic leukemia progression
Secondary outcomes:
measure: Frequency measurement of 1q amplification
timeFrame: immediately after the chronic lymphocytic leukemia progression
measure: Differential expression of candidate transcripts and proteins
timeFrame: immediately after the chronic lymphocytic leukemia progression
measure: Correlation of resistance mechanisms with clinical staging
timeFrame: immediately after the chronic lymphocytic leukemia progression
measure: Correlation of resistance mechanisms with genomic chronic lymphocytic leukemia features
timeFrame: immediately after the chronic lymphocytic leukemia progression
measure: Progression Free Survival according to resistance mechanisms
timeFrame: immediately after the chronic lymphocytic leukemia progression
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU d'Amiens
city: Besançon
country: France
facility: CHU de Besançon
city: Bobigny
country: France
facility: Hopital AVICENNE
city: Clermont-Ferrand
country: France
facility: CHU clermont-ferrand
city: Clermont-Ferrand
country: France
facility: CHU de Clermont Ferrand
city: Grenoble
country: France
facility: CHU Grenoble
city: Lille
country: France
facility: CHRU de Lille
city: Lyon
country: France
facility: Centre LEON BERARD
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nancy
country: France
facility: CHU Nancy
city: Paris
country: France
facility: Hopital Pitié Salpetrière
city: Pessac
country: France
facility: Hopital Haut LEVEQUE
city: Reims
country: France
facility: CHU de Reims
city: Toulouse
country: France
facility: IUCT Oncopole
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Romain GUIEZE
role: PRINCIPAL_INVESTIGATOR
References: