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

March 8, 2023 updated by: AbbVie

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

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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
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.
Up to Approximately 7 Years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2020

Primary Completion (Anticipated)

September 30, 2025

Study Completion (Anticipated)

September 30, 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 (Estimate)

March 9, 2023

Last Update Submitted That Met QC Criteria

March 8, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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