Reassessment of Hemolytic Syndrome Risk in Chronic Lymphocytic Leukemia Patients Treated With Venetoclax-Containing Regimen

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study reviews the risk of hemolytic syndrome in patients with chronic lymphocytic leukemia who receive venetoclax in combination with BTK inhibitors or obinutuzumab. It uses imaging and clinical data to reassess safety in first-line or relapse settings. Eligible participants will undergo CT scanning across cervical, thoracic, abdominal, and pelvic regions as part of safety monitoring. The study builds on prior findings that early venetoclax use can trigger tumor lysis under certain conditions. Results may clarify risk profiles and guide safer administration.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with chronic lymphocytic leukemia/lymphocytic lymphoma
* Meeting the treatment criteria according to iwCLL 2018
* Eligible for treatment with venetoclax in combination with a Bruton's tyrosine kinase inhibitor (ibrutinib, other approved generations) or obinutuzumab
* First-line treatment or relapse

Exclusion Criteria:

* Patients with meningeal and/or cerebral involvement
* Patients with an active, uncontrolled infection
* Patients scheduled to receive venetoclax monotherapy or rituximab-venetoclax according to the MURANO study regimen (Murano regimen: venetoclax is administered before rituximab)
* Contraindications to contrast-enhanced CT scanning (severe renal insufficiency, documented allergy to contrast agents).
* Pregnancy or breastfeeding
* Individuals deprived of their liberty, under legal guardianship, or under conservatorship
* Dementia, mental impairment, or psychiatric disorder that could compromise the patient's ability to provide informed consent and/or to adhere to the protocol and follow-up requirements of the trial

Where it's running

• Hôpital Privé du Confluent
  Nantes, France Recruiting
• Clinique de l'Europe
  Amiens, France Not yet recruiting

Study contacts

• Study coordinator: Marion Mandon, PhD
• Email: mmandon@vivalto-sante.com
• Phone: +33 6 78 27 76 72

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.