Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Refractory Leukemia | Leukemia | CURATED_BROADER | 0.78 |
| Relapse Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Venetoclax | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- cohort group
- description
- Patients who have received at least one dose of venetoclax
- interventionNames
- Drug: Venetoclax
Primary outcomes (1)
- 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.
- timeFrame
- 15 months
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available