NCT05246345

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
10mo left

Started Mar 2022

Longer than P75 for all trials

Geographic Reach
1 country

14 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Mar 2022Mar 2027

First Submitted

Initial submission to the registry

October 13, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 18, 2022

Completed
17 days until next milestone

Study Start

First participant enrolled

March 7, 2022

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

January 9, 2024

Status Verified

June 1, 2023

Enrollment Period

5 years

First QC Date

October 13, 2021

Last Update Submit

January 8, 2024

Conditions

Chronic Lymphocytic LeukemiaCLLProgressive Chronic Lymphocytic LeukemiaRefractory Chronic Lymphocytic LeukemiaRelapsed Chronic Lymphocytic Leukemia

Keywords

VenetoclaxVenetoclax resistanceResistance mechanism

Outcome Measures

Primary Outcomes (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

    immediately after the chronic lymphocytic leukemia progression

Secondary Outcomes (5)

  • Frequency measurement of 1q amplification

    immediately after the chronic lymphocytic leukemia progression

  • Differential expression of candidate transcripts and proteins

    immediately after the chronic lymphocytic leukemia progression

  • Correlation of resistance mechanisms with clinical staging

    immediately after the chronic lymphocytic leukemia progression

  • Correlation of resistance mechanisms with genomic chronic lymphocytic leukemia features

    immediately after the chronic lymphocytic leukemia progression

  • Progression Free Survival according to resistance mechanisms

    immediately after the chronic lymphocytic leukemia progression

Study Arms (1)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Patients of their legal guardians refusing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

CHU d'Amiens

Amiens, France

NOT YET RECRUITING

CHU de Besançon

Besançon, France

NOT YET RECRUITING

Hopital AVICENNE

Bobigny, France

NOT YET RECRUITING

CHU clermont-ferrand

Clermont-Ferrand, France

NOT YET RECRUITING

CHU de Clermont Ferrand

Clermont-Ferrand, France

NOT YET RECRUITING

CHU Grenoble

Grenoble, France

NOT YET RECRUITING

CHRU de Lille

Lille, France

NOT YET RECRUITING

Centre LEON BERARD

Lyon, France

NOT YET RECRUITING

CHU de Montpellier

Montpellier, France

NOT YET RECRUITING

CHU Nancy

Nancy, France

NOT YET RECRUITING

Hopital Pitié Salpetrière

Paris, France

NOT YET RECRUITING

Hopital Haut LEVEQUE

Pessac, France

NOT YET RECRUITING

CHU de Reims

Reims, France

RECRUITING

IUCT Oncopole

Toulouse, France

NOT YET RECRUITING

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Romain GUIEZE

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963promo_interne_drci@chu-clermontferrand.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2021

First Posted

February 18, 2022

Study Start

March 7, 2022

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

January 9, 2024

Record last verified: 2023-06

Locations

FR(14)