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NCT05246345 Clinical Trial

Venetoclax Resistance Landscape in Chronic Lymphocytic Leukemia

Chronic Lymphocytic Leukemia Clinical Trial

— RAVEN  

Official title:
Venetoclax Resistance Landscape in Chronic Lymphocytic Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05246345
Other study ID # RNI 2021 GUIEZE
Secondary ID 2021-A00362-39
Status Recruiting
Phase
First received
Last updated
Start date March 7, 2022
Est. completion date March 2027

Study information
Verified date June 2023
Source University Hospital, Clermont-Ferrand
Contact Lise Laclautre
Phone 334.73.754.963
Email promo_interne_drci@chu-clermontferrand.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date March 2027
Est. primary completion date March 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 -

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France CHU d'Amiens Amiens
France CHU de Besançon Besançon
France Hopital AVICENNE Bobigny
France CHU clermont-ferrand Clermont-Ferrand
France CHU de Clermont Ferrand Clermont-Ferrand
France CHU Grenoble Grenoble
France CHRU de Lille Lille
France Centre LEON BERARD Lyon
France CHU de Montpellier Montpellier
France CHU Nancy Nancy
France Hopital Pitié Salpetrière Paris
France Hopital Haut LEVEQUE Pessac
France CHU de Reims Reims
France IUCT Oncopole Toulouse

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Frequency measurement of BCL2 gene mutations Frequency measurement of BCL2 gene mutations in a cohort of refractory and/or relapsed chronic lymphocytic leukemia during or after venetoclax therapy immediately after the chronic lymphocytic leukemia progression
Secondary Frequency measurement of 1q amplification Frequency measurement of 1q amplification in a cohort of refractory and/or relapsed chronic lymphocytic leukemia during or after venetoclax therapy immediately after the chronic lymphocytic leukemia progression
Secondary Differential expression of candidate transcripts and proteins 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 immediately after the chronic lymphocytic leukemia progression
Secondary Correlation of resistance mechanisms with clinical staging 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 immediately after the chronic lymphocytic leukemia progression
Secondary Correlation of resistance mechanisms with genomic chronic lymphocytic leukemia features 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 immediately after the chronic lymphocytic leukemia progression
Secondary Progression Free Survival according to resistance mechanisms 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 immediately after the chronic lymphocytic leukemia progression
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