Venetoclax Resistance Landscape in Chronic Lymphocytic Leukemia

NCT ID: NCT05246345

Last Updated: 2024-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-07

Study Completion Date

2027-03-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Chronic Lymphocytic Leukemia CLL Progressive Chronic Lymphocytic Leukemia Refractory Chronic Lymphocytic Leukemia Relapsed Chronic Lymphocytic Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Romain GUIEZE

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU d'Amiens

Amiens, , France

Site Status NOT_YET_RECRUITING

CHU de Besançon

Besançon, , France

Site Status NOT_YET_RECRUITING

Hopital AVICENNE

Bobigny, , France

Site Status NOT_YET_RECRUITING

CHU clermont-ferrand

Clermont-Ferrand, , France

Site Status NOT_YET_RECRUITING

CHU de Clermont Ferrand

Clermont-Ferrand, , France

Site Status NOT_YET_RECRUITING

CHU Grenoble

Grenoble, , France

Site Status NOT_YET_RECRUITING

CHRU de Lille

Lille, , France

Site Status NOT_YET_RECRUITING

Centre LEON BERARD

Lyon, , France

Site Status NOT_YET_RECRUITING

CHU de Montpellier

Montpellier, , France

Site Status NOT_YET_RECRUITING

CHU Nancy

Nancy, , France

Site Status NOT_YET_RECRUITING

Hopital Pitié Salpetrière

Paris, , France

Site Status NOT_YET_RECRUITING

Hopital Haut LEVEQUE

Pessac, , France

Site Status NOT_YET_RECRUITING

CHU de Reims

Reims, , France

Site Status RECRUITING

IUCT Oncopole

Toulouse, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Lise Laclautre

Role: CONTACT

334.73.754.963

Facility Contacts

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Lise Laclautre

Role: primary

Lise Laclautre

Role: primary

Lise Laclautre

Role: primary

Lise Laclautre

Role: primary

Lise Laclautre

Role: primary

Lise Laclautre

Role: primary

Lise Laclautre

Role: primary

Lise Laclautre

Role: primary

Lise Laclautre

Role: primary

Lise Laclautre

Role: primary

Lise Laclautre

Role: primary

lise Laclautre

Role: primary

Lise Laclautre

Role: primary

Lise Laclautre

Role: primary

Other Identifiers

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2021-A00362-39

Identifier Type: OTHER

Identifier Source: secondary_id

RNI 2021 GUIEZE

Identifier Type: -

Identifier Source: org_study_id

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