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

Study Overview
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Brief Summary
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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 October 31st, 2021.

Detailed Description
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A longitudinal survey will be carried out by collecting data of patients who received at least 1 dose of venetoclax. The study includes two different groups: a retrospective group (all patients who have received at least one dose of venetoclax before enrolment) and a prospective group (patients receiving treatment with venetoclax after enrolment). All patients in both groups will be observed for up to 48 months from the treatment start. In the prospective cohort only, QoL will be assessed at the time of study entry (i.e. baseline) and thereafter at 3, 6, 9, 12, 18 24, 30, 36, 42 and 48 months of follow-up and at treatment discontinuation (due to any cause).

Official Title
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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

Conditions
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Chronic Lymphocytic Leukemia, Relapse Leukemia, Refractory Leukemia

Intervention / Treatment
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* Drug: Venetoclax


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria 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. Patients with R/R 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 October 31st, 2021. 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cohort group<br>Patients who have received at least one dose of venetoclax | Drug: Venetoclax<br>* Patients treated with venetoclax-based regimens outside clinical trials in Italy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimation of the PFS in relapsed/refractory (R/R) patients with CLL treated with venetoclax-based regimens according to the local label outside clinical trials in Italy. | Estimation of the PFS at 15 months from the start of venetoclax treatment in patients with R/R CLL who started treatment with venetoclax-based regimens according to the local label from the start of the Venetoclax Named Patient Program (March 2016) until October 31st, 2021 | 15 months |