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Cancer, Chronic Lymphocytic Leukemia (CLL)NCT04178317

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

An observational study of Cancer, Chronic Lymphocytic Leukemia (CLL), run by AbbVie at 13 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 19 years and older
How many people
14 participants
Where
13 sitesSouth Korea
Study dates
2 Apr 2020to 18 Aug 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

South Korea13 sites

  • Inje University - Busan Paik Hospital /ID# 233882

    Busan, Busan Gwang Yeogsi, 47392

  • Pusan National University Hospital /ID# 216850

    Busan, Busan Gwang Yeogsi, 49241

  • Kyungpook National University Hospital /ID# 233884

    Daegu, Daegu Gwang Yeogsi, 41944

  • Chonnam National University Hwasun Hospital /ID# 216849

    Hwasun-gun, Jeonranamdo, 58128

  • The catholic university of korea st. Paul's hospital /ID# 238907

    Seoul, Gyeonggido, 03300

  • Korea University Anam Hospital /ID# 216851

    Seoul, Seoul Teugbyeolsi, 02841

  • Seoul National University Hospital /ID# 216853

    Seoul, Seoul Teugbyeolsi, 03080

  • Samsung Medical Center /ID# 217180

    Seoul, Seoul Teugbyeolsi, 06351

  • The Catholic University of Korea, Seoul St. Marys Hospital /ID# 216852

    Seoul, Seoul Teugbyeolsi, 06591

  • The Catholic University of Korea, Seoul St. Marys Hospital /ID# 217181

    Seoul, Seoul Teugbyeolsi, 06591

  • The Catholic University of Korea, Yeouido ST. Mary's Hospital /ID# 217179

    Seoul, Seoul Teugbyeolsi, 07345

  • Yonsei University Health System Severance Hospital /ID# 215348

    Seoul, 03722

  • Ajou University Hospital /ID# 249512

    Suwon, Gyeonggido, 16499

Other trials in South Korea

About this study

Official title: 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).

Keywords
Cancer, Chronic Lymphocytic Leukemia (CLL), Venetoclax
Medical subject headings
Neoplasms, Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04178317
Study groupRoleWhat they receive
Venetoclax ParticipantsParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to Approximately 7 Years

Secondary outcomes (1)

  1. 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.

    Measured: Up to Approximately 7 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2019
  2. Study start2 Apr 2020
  3. Primary completion18 Aug 2025
  4. Study completion18 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04178317
Sponsor's protocol ID
P19-942
Status last verified
Dec 2025
First submitted
25 Nov 2019
Last updated
4 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer, Chronic Lymphocytic Leukemia (CLL), run by AbbVie at 13 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (time frame: Up to Approximately 7 Years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04178317.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.

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