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

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

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Key information

Conditions

Cancer, Chronic Lymphocytic Leukemia (CLL) Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Inje University - Busan Paik Hospital /ID# 233882, Busan, Busan Gwang Yeogsi, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Number of Participants With Adverse Events

Time frame: 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 outcomes

Overall Response

Time frame: 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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2025
Study completion: 2025
First posted: Nov 26, 2019
Registry last updated: Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed