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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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 Besançon
        • 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 Pitié Salpetrière
        • Contact:
          • Lise Laclautre
        • Principal Investigator:
          • Damien Roos-Weil
      • Pessac, France
        • Not yet recruiting
        • Hôpital 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Cohort of refractory and/or relapsed chronic lymphocytic leukemia during or after venetoclax

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Clermont-Ferrand

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 7, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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