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CompletedNCT04178317Updated Dec 4, 2025

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

An observational study in Cancer, Chronic Lymphocytic Leukemia (CLL), sponsored by AbbVie. Completed at 13 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-12-04.

Sponsored by AbbVie · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
14
Ages
19 Years and older
Sex
All
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Study 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).

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Conditions studied

  • Cancer, Chronic Lymphocytic Leukemia (CLL)

Keywords

  • Cancer, Chronic Lymphocytic Leukemia (CLL), Venetoclax
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In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 14 is below the median of 204 across 1,683 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.

Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
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.

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

Exclusion Criteria:

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

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
14 participants (actual)

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  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.

    Time frame: Up to Approximately 7 Years

Secondary outcomes

  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.

    Time frame: Up to Approximately 7 Years

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Study locations

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

Related links

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04178317
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Nov 26, 2019
Start date
Apr 2, 2020
Primary completion
Aug 18, 2025
Completion
Aug 18, 2025
Last update
Dec 4, 2025

Study contacts

ABBVIE INC.
study director · AbbVie

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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