NCT04282811

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 321 (estimated)
• Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Observational study to describe the characteristics and outcome of CLL patients treated with venetoclax according to the local label. 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 and treatment adherence 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).

Conditions

• Chronic Lymphocytic Leukemia
• Relapse Leukemia
• Refractory Leukemia

Interventions

Type	Name	Description
DRUG	Venetoclax	Patients treated with venetoclax-based regimens outside clinical trials in Italy

Timeline

• Start date: 2020-07-24
• Primary completion: 2023-01-31
• Completion: 2025-10-31
• First posted: 2020-02-25
• Last updated: 2025-01-17

Locations

27 sites across 1 country: Italy

Regulatory

• FDA-regulated drug study