A Study of the Safety and Efficacy of Venetoclax for Participants With Chronic Lymphocytic Leukemia (CLL) Used in Routine Clinical Practice

Venetoclax (Venclexta Tablet) Post-Marketing Surveillance for CLL Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04178317

Enrollment

Registered

2019-11-26

Start date

2020-04-02

Completion date

2025-08-18

Last updated

2025-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Chronic Lymphocytic Leukemia (CLL)

Keywords

Cancer, Chronic Lymphocytic Leukemia (CLL), Venetoclax

Brief summary

This observational study will evaluate the safety and effectiveness of Venetoclax used in routine clinical practice for participants diagnosed with chronic lymphocytic leukemia (CLL).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

* Participants diagnosed with chronic lymphocytic leukemia who have been prescribed Venetoclax for the first time according to the approved label * Participants (and/or legal representative) who voluntarily agree to participate in this study and sign informed consent

Exclusion criteria

-Participants with contraindications to venetoclax as listed on the approved local label

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Adverse Events	Up to Approximately 7 Years	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. For more details on adverse events please see the Adverse Event section.

Secondary

Measure	Time frame	Description
Overall Response	Up to Approximately 7 Years	Overall Response will be assessed by the physician in charge of the study in accordance with the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines.

Countries

South Korea

Outcome results