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NCT Number: NCT05246345

Venetoclax Resistance Landscape in Chronic Lymphocytic Leukemia

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.

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Key information

Conditions

Chronic Lymphocytic Leukemia CLL Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Progressive Chronic Lymphocytic Leukemia Refractory Chronic Lymphocytic Leukemia Relapsed Chronic Lymphocytic Leukemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU d'Amiens, Amiens, France

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Primary outcomes

  1. Frequency measurement of BCL2 gene mutations

    Time frame: 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 outcomes

  1. Frequency measurement of 1q amplification

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Lise Laclautre

CONTACT

[email protected]

334.73.754.963

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: RAVEN

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Feb 18, 2022
Registry last updated
Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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