Venetoclax Resistance Landscape in Chronic Lymphocytic Leukemia (RAVEN)

January 8, 2024 updated by: University Hospital, Clermont-Ferrand
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Amiens, France
        • Not yet recruiting
        • CHU D'amiens
        • Contact:
          • Lise Laclautre
        • Principal Investigator:
          • Pierre Morel
      • Besançon, France
        • Not yet recruiting
        • CHU de Besancon
        • Contact:
          • Lise Laclautre
        • Principal Investigator:
          • Annie Brion
      • Bobigny, France
        • Not yet recruiting
        • Hôpital Avicenne
        • Principal Investigator:
          • Vincent LEVY
        • Contact:
          • Lise Laclautre
      • Clermont-Ferrand, France
        • Not yet recruiting
        • Chu Clermont-Ferrand
        • Contact:
          • Lise Laclautre
        • Principal Investigator:
          • Romain Guieze
      • Clermont-Ferrand, France
        • Not yet recruiting
        • CHU de Clermont Ferrand
        • Contact:
          • Lise Laclautre
        • Principal Investigator:
          • Nataliya DMYTRUCK
      • Grenoble, France
        • Not yet recruiting
        • CHU Grenoble
        • Contact:
          • Lise Laclautre
        • Principal Investigator:
          • Sylvain CARRAS
      • Lille, France
        • Not yet recruiting
        • CHRU de Lille
        • Contact:
          • Lise Laclautre
        • Principal Investigator:
          • Morgane NUDEL
      • Lyon, France
        • Not yet recruiting
        • Centre Léon Bérard
        • Contact:
          • Lise Laclautre
        • Principal Investigator:
          • Anne-Sophie MICHALLET
      • Montpellier, France
        • Not yet recruiting
        • CHU de Montpellier
        • Contact:
          • Lise Laclautre
        • Principal Investigator:
          • Emmanuelle Tchernonog
      • Nancy, France
        • Not yet recruiting
        • CHU Nancy
        • Principal Investigator:
          • Pierre Feugier
        • Contact:
          • Lise Laclautre
      • Paris, France
        • Not yet recruiting
        • Hopital Pitie Salpetriere
        • Contact:
          • Lise Laclautre
        • Principal Investigator:
          • Damien Roos-Weil
      • Pessac, France
        • Not yet recruiting
        • Hopital Haut Lévêque
        • Principal Investigator:
          • Marie-Sarah DILHUYDY
        • Contact:
          • Lise Laclautre
      • Reims, France
        • Recruiting
        • CHU de Reims
        • Principal Investigator:
          • Anne QUINQUENEL
        • Contact:
          • Lise Laclautre
      • Toulouse, France
        • Not yet recruiting
        • IUCT Oncopole
        • Contact:
          • Lise Laclautre
        • Principal Investigator:
          • Loïc Ysebaert

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
immediately after the chronic lymphocytic leukemia progression

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
immediately after the chronic lymphocytic leukemia progression
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
immediately after the chronic lymphocytic leukemia progression
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
immediately after the chronic lymphocytic leukemia progression
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
immediately after the chronic lymphocytic leukemia progression
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
immediately after the chronic lymphocytic leukemia progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2022

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

October 13, 2021

First Submitted That Met QC Criteria

February 17, 2022

First Posted (Actual)

February 18, 2022

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RNI 2021 GUIEZE
  • 2021-A00362-39 (Other Identifier: 2021-A00362-39)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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