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Chronic Lymphocytic LeukemiaRAVENNCT05246345

Venetoclax Resistance Landscape in Chronic Lymphocytic Leukemia

An observational study of Chronic Lymphocytic Leukemia and CLL, run by University Hospital, Clermont-Ferrand at 14 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
50 participants
Where
14 sitesFrance
Study dates
7 Mar 2022to Mar 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • Patients of their legal guardians refusing to participate
  • -

Trial locations and contacts

14 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lise Laclautre contact

334.73.754.963

promo_interne_drci@chu-clermontferrand.fr

14 sites in 1 country

France14 sites, 14 recruiting

  • CHU d'Amiens

    Amiens

    Lise Laclautre

    Pierre Morel

    Not yet recruiting

  • CHU de Besançon

    Besançon

    Lise Laclautre

    Annie Brion

    Not yet recruiting

  • Hopital AVICENNE

    Bobigny

    Lise Laclautre

    Vincent LEVY

    Not yet recruiting

  • CHU clermont-ferrand

    Clermont-Ferrand

    Lise Laclautre

    Romain GUIEZE

    Not yet recruiting

  • CHU de Clermont Ferrand

    Clermont-Ferrand

    Lise Laclautre

    Nataliya DMYTRUCK

    Not yet recruiting

  • CHU Grenoble

    Grenoble

    Lise Laclautre

    Sylvain CARRAS

    Not yet recruiting

  • CHRU de Lille

    Lille

    Lise Laclautre

    Morgane NUDEL

    Not yet recruiting

  • Centre LEON BERARD

    Lyon

    Lise Laclautre

    Anne-Sophie MICHALLET

    Not yet recruiting

  • CHU de Montpellier

    Montpellier

    Lise Laclautre

    Emmanuelle TCHERNONOG

    Not yet recruiting

  • CHU Nancy

    Nancy

    Lise Laclautre

    Pierre Feugier

    Not yet recruiting

  • Hopital Pitié Salpetrière

    Paris

    Lise Laclautre

    Damien ROOS-WEIL

    Not yet recruiting

  • Hopital Haut LEVEQUE

    Pessac

    lise Laclautre

    Marie-Sarah DILHUYDY

    Not yet recruiting

  • CHU de Reims

    Reims

    Lise Laclautre

    Anne QUINQUENEL

    Recruiting

  • IUCT Oncopole

    Toulouse

    Lise Laclautre

    Loïc YSEBAERT

    Not yet recruiting

Other trials in France

About this study

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.

Read the 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).

Keywords
Venetoclax, Venetoclax resistance, Resistance mechanism
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05246345
Study groupRoleWhat they receive
Cohort of refractory and/or relapsed chronic lymphocytic leukemia during or after venetoclaxCohort of refractory and/or relapsed chronic lymphocytic leukemia during or after venetoclax

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: immediately after the chronic lymphocytic leukemia progression

Secondary outcomes (5)

  1. 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

    Measured: immediately after the chronic lymphocytic leukemia progression

  2. 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

    Measured: immediately after the chronic lymphocytic leukemia progression

  3. 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

    Measured: immediately after the chronic lymphocytic leukemia progression

  4. 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

    Measured: immediately after the chronic lymphocytic leukemia progression

  5. 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

    Measured: immediately after the chronic lymphocytic leukemia progression

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2022
  2. Study start7 Mar 2022
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05246345
Sponsor's protocol ID
RNI 2021 GUIEZE
Other IDs
2021-A00362-39
Acronym
RAVEN
Status last verified
Jun 2023
First submitted
13 Oct 2021
Last updated
9 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Lymphocytic Leukemia and CLL, run by University Hospital, Clermont-Ferrand at 14 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency measurement of BCL2 gene mutations (time frame: immediately after the chronic lymphocytic leukemia progression). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05246345.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.

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