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

Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
Study ID
NCT04282811
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    Patients treated with venetoclax-based regimens outside clinical trials in Italy

Study Details

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.

Key Dates

Start date
Jul 24, 2020
Status verified
Jun 2026
Primary completion
Jan 31, 2023
Completion
Oct 31, 2026

Study Design

Enrollment
321 participants (estimated)

Arms

  • Arm: cohort group
    Patients who have received at least one dose of venetoclax

Primary Outcome Measure

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. [ Time Frame: 15 months ]

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