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RAVEN: Venetoclax Resistance Landscape in Chronic Lymphocytic Leukemia

Sponsor
University Hospital, Clermont-Ferrand (Other)
Overall Status
Recruiting
CT.gov ID
NCT05246345
Collaborator
(none)
30
Enrollment
9
Locations
33.9
Anticipated Duration (Months)
3.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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).

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Venetoclax Resistance Landscape in Chronic Lymphocytic Leukemia
    Actual Study Start Date :
    Mar 7, 2022
    Anticipated Primary Completion Date :
    Jan 1, 2025
    Anticipated Study Completion Date :
    Jan 1, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Cohort of refractory and/or relapsed chronic lymphocytic leukemia during or after venetoclax

    Cohort of refractory and/or relapsed chronic lymphocytic leukemia during or after venetoclax

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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

    2. 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

    3. 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

    4. 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

    5. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hopital AVICENNE Bobigny France
    2 CHU clermont-ferrand Clermont-Ferrand France
    3 CHU Grenoble Grenoble France
    4 Centre LEON BERARD Lyon France
    5 CHU Nancy Nancy France
    6 Hopital Pitié Salpetrière Paris France
    7 Hopital Haut LEVEQUE Pessac France
    8 CHU de Reims Reims France
    9 IUCT Oncopole Toulouse France

    Sponsors and Collaborators

    • University Hospital, Clermont-Ferrand

    Investigators

    • Principal Investigator: Romain GUIEZE, University Hospital, Clermont-Ferrand

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Clermont-Ferrand
    ClinicalTrials.gov Identifier:
    NCT05246345
    Other Study ID Numbers:
    • RNI 2021 GUIEZE
    • 2021-A00362-39
    First Posted:
    Feb 18, 2022
    Last Update Posted:
    Apr 4, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Clermont-Ferrand
    Venetoclax
    Venetoclax resistance
    Resistance mechanism
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Lymphoid
    Leukemia, Lymphocytic, Chronic, B-Cell

    Study Results

    No Results Posted as of Apr 4, 2022