Understanding resistance to venetoclax in chronic lymphocytic leukemia
Venetoclax Resistance Landscape in Chronic Lymphocytic Leukemia
This study is trying to understand why some patients with chronic lymphocytic leukemia don’t respond to the treatment venetoclax by looking at their medical information and samples.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Locations | 14 sites (Amiens and 13 other locations) |
| Trial ID | NCT05246345 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather medical information and biological samples from patients with refractory or relapsed chronic lymphocytic leukemia (CLL) who are undergoing or have undergone treatment with venetoclax. The focus is on evaluating the frequency of resistance mechanisms, including BCL2 mutations and changes in energy metabolism. By analyzing blood, bone marrow, and lymph node samples, the study seeks to provide insights into how CLL can resist venetoclax treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of refractory or relapsed chronic lymphocytic leukemia during or after venetoclax treatment.
Not a fit: Patients who are not undergoing venetoclax treatment or do not have available tumor samples may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding of resistance mechanisms in CLL, potentially guiding more effective treatment strategies.
How similar studies have performed: While studies on venetoclax resistance exist, this specific observational approach focusing on resistance mechanisms in CLL is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 \-
Where this trial is running
Amiens and 13 other locations
- 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)
Study contacts
- Principal investigator: Romain GUIEZE — University Hospital, Clermont-Ferrand
- Study coordinator: Lise Laclautre
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: 334.73.754.963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.