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

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

Study Overview

• Status: Completed
• Conditions: Cancer, Chronic Lymphocytic Leukemia (CLL)

• Study Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea, 03722
    • Yonsei University Health System Severance Hospital /ID# 215348
  • Busan Gwang Yeogsi
    • Busan, Busan Gwang Yeogsi, South Korea, 47392
      • Inje University - Busan Paik Hospital /ID# 233882
    • Busan, Busan Gwang Yeogsi, South Korea, 49241
      • Pusan National University Hospital /ID# 216850
  • Daegu Gwang Yeogsi
    • Daegu, Daegu Gwang Yeogsi, South Korea, 41944
      • Kyungpook National University Hospital /ID# 233884
  • Gyeonggido
    • Seoul, Gyeonggido, South Korea, 03300
      • The catholic university of korea st. Paul's hospital /ID# 238907
    • Suwon, Gyeonggido, South Korea, 16499
      • Ajou University Hospital /ID# 249512
  • Jeonranamdo
    • Hwasun-gun, Jeonranamdo, South Korea, 58128
      • Chonnam National University Hwasun Hospital /ID# 216849
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, South Korea, 02841
      • Korea University Anam Hospital /ID# 216851
    • Seoul, Seoul Teugbyeolsi, South Korea, 03080
      • Seoul National University Hospital /ID# 216853
    • Seoul, Seoul Teugbyeolsi, South Korea, 06351
      • Samsung Medical Center /ID# 217180
    • Seoul, Seoul Teugbyeolsi, South Korea, 06591
      • The Catholic University of Korea, Seoul St. Marys Hospital /ID# 216852
    • Seoul, Seoul Teugbyeolsi, South Korea, 06591
      • The Catholic University of Korea, Seoul St. Marys Hospital /ID# 217181
    • Seoul, Seoul Teugbyeolsi, South Korea, 07345
      • The Catholic University of Korea, Yeouido ST. Mary's Hospital /ID# 217179

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

- Participants with chronic lymphocytic leukemia (CLL) who are prescribed venetoclax within the approved label according to physician judgement.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Venetoclax Participants; Participants receiving venetoclax for chronic lymphocytic leukemia according to the approved local label, and the decision to prescribe Venetoclax is independent from the enrollment into the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events	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.	Up to Approximately 7 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response	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.	Up to Approximately 7 Years

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info.

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2020
• Primary Completion (Actual): August 18, 2025
• Study Completion (Actual): August 18, 2025

Study Registration Dates

• First Submitted: November 25, 2019
• First Submitted That Met QC Criteria: November 25, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Cancer, Chronic Lymphocytic Leukemia (CLL), Venetoclax
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Neoplasms; Leukemia, Lymphocytic, Chronic, B-Cell
• Other Study ID Numbers: P19-942

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No