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Observational study on CLL patients treated with venetoclax in Italy

An Observational Study to Evaluate the Clinical and Biologic Features and Outcome of Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) Treated With Venetoclax-based Regimens Outside Clinical Trials in Italy

Observational Gruppo Italiano Malattie EMatologiche dell'Adulto · NCT04282811

This study looks at how well venetoclax works for people in Italy with relapsed or refractory chronic lymphocytic leukemia and gathers information on their experiences and outcomes while being treated.

Quick facts

Study typeObservational
Enrollment321 (estimated)
Ages18 Years and up
SexAll
SponsorGruppo Italiano Malattie EMatologiche dell'Adulto Academic / other
Locations27 sites (Cona, Ferrara and 26 other locations)
Trial IDNCT04282811 on ClinicalTrials.gov

What this trial studies

This observational study aims to describe the characteristics and outcomes of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) who are treated with venetoclax-based regimens according to local guidelines outside of clinical trials in Italy. The study includes both a retrospective cohort of patients who have already received treatment and a prospective cohort of patients who will begin treatment after enrollment. Participants will be monitored for up to 48 months, with assessments of quality of life and treatment adherence conducted at multiple time points. The study seeks to gather real-world data on the effectiveness and safety of venetoclax in this patient population.

Who should consider this trial

Good fit: Ideal candidates include patients with relapsed or refractory CLL who have received at least one dose of venetoclax or are scheduled to start treatment with venetoclax before June 30th, 2025.

Not a fit: Patients who have not received venetoclax or are not eligible for the Venetoclax Named Patient Program may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of venetoclax for CLL patients in a real-world setting.

How similar studies have performed: Other studies have shown success with similar observational approaches in understanding treatment outcomes for CLL patients, making this study a valuable addition to existing knowledge.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria

1. Patients with R/R CLL fulfilling the eligibility criteria required by the Venetoclax Named Patient Program who have received at least 1 dose of venetoclax.
2. Patients with CLL who have received at least 1 dose of venetoclax or are scheduled to start treatment with venetoclax according to the Post-marketing Use before June 30th, 2025.
3. Signed informed consent document (if feasible) according to ICH/EU/GCP and national local laws indicating that the patients understand the purpose of the study and they agree to give complete access to their medical records.

Exclusion Criteria:

None

Where this trial is running

Cona, Ferrara and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Lymphocytic LeukemiaRelapse LeukemiaRefractory Leukemia
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.