Observational Study Relapsed or Refractory Chronic Lymphocytic Leukemia Venetoclax-based Regimens Outside Clinical Trials in Italy

Conditions: Chronic Lymphocytic Leukemia, Relapse Leukemia, Refractory Leukemia

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: No

Enrollment: 321

Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

Location: Aou Arcispedale Sant'Anna - Cona (Fe) - Uoc Ematologia E Fisiopatologia Della Coagulazione Cona Ferrara

Summary

Observational study aimed at describing the characteristics and outcome of CLL patients who started treatment with venetoclax-based regimens according to the local label outside clinical trials in Italy in a period of time ranging from the start of the Venetoclax Named Patient Program (March 2016) until June 30th, 2025.

Eligibility 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04282811). StuddyBuddy aggregates publicly available trial information.