An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial

May 11, 2026 updated by: AbbVie
The purpose of this extension study is to provide venetoclax and obtain long-term safety data for subjects who continue to tolerate and derive benefit from receiving venetoclax in ongoing studies.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
165

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Available

Available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 outside the clinical trial. See expanded access record.

Contacts and Locations

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

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital /ID# 239557
      • Kogarah, New South Wales, Australia, 2217
        • St George Hospital /ID# 225589
      • Liverpool, New South Wales, Australia, 2170
        • Liverpool Hospital /ID# 225591
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Peter MacCallum Cancer Ctr /ID# 210559
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Fiona Stanley Hospital /ID# 239480
      • Nedlands, Western Australia, Australia, 6009
        • Perth Blood Institute Ltd /ID# 225592
  • Austria
    • Styria
      • Graz, Styria, Austria, 8010
        • Duplicate_Medizinische Universitaet Graz /ID# 223817
  • Belgium
    • Brussels Capital
      • Brussels, Brussels Capital, Belgium, 1200
        • Cliniques Universitaires UCL Saint-Luc /ID# 224327
  • Canada
    • Quebec
      • Québec, Quebec, Canada, G1J 1Z4
        • CHUQ- Hôpital de l'Enfant-Jesus /ID# 224616
  • Denmark
    • Capital Region
      • Copenhagen Ø, Capital Region, Denmark, 2100
        • Rigshospitalet /ID# 224213
    • Central Jutland
      • Aarhus, Central Jutland, Denmark, 8200
        • Aarhus Universitetshospital - Skejby /ID# 224214
  • France
    • Isere
      • La Tronche, Isere, France, 38700
        • CHU Grenoble - Hopital Michallon /ID# 240497
    • Rhone
      • Pierre-Bénite, Rhone, France, 69495
        • HCL - Hopital Lyon Sud /ID# 213508
  • Greece
      • Thessaloniki, Greece, 57010
        • General Hospital of Thessaloniki George Papanikolaou /ID# 224088
    • Attica
      • Athens, Attica, Greece, 11527
        • General Hospital of Athens Laiko /ID# 224087
  • Hong Kong
      • Hong Kong, Hong Kong, 999077
        • Queen Mary Hospital /ID# 224944
  • Ireland
      • Dublin, Ireland, D09 XR63
        • Beaumont Hospital /ID# 225165
  • Japan
    • Hyōgo
      • Kobe, Hyōgo, Japan, 650-0047
        • Kobe City Medical Center General Hospital /ID# 241518
    • Ibaraki
      • Higashi Ibaraki-gun, Ibaraki, Japan, 311-3193
        • Duplicate_National Hospital Organization Mito Medical Center /ID# 241986
    • Okayama-ken
      • Okayama, Okayama-ken, Japan, 701-1192
        • Duplicate_Okayama Medical Center /ID# 241517
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital /ID# 241516
  • Mexico
    • Michoacán
      • Morelia, Michoacán, Mexico, 58260
        • Centro de Investigacion Clínica Chapultepec SA de CV /ID# 227018
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 227017
  • New Zealand
    • Auckland
      • Papatoetoe, Auckland, New Zealand, 2025
        • Aotearoa Clinical Trials /ID# 225596
      • Takapuna, Auckland, New Zealand, 0622
        • North Shore Hospital /ID# 225597
    • Wellington Region
      • Newtown, Wellington Region, New Zealand, 6021
        • Wellington Regional Hospital /ID# 225593
  • Poland
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 30-727
        • Duplicate_Pratia MCM Krakow /ID# 218561
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-776
        • Instytut Hematologii i Transfuzjologii /ID# 225478
    • Silesian Voivodeship
      • Chorzów, Silesian Voivodeship, Poland, 41-500
        • SP ZOZ Zespol Szpitali Miejskich w Chorzowie /ID# 225474
  • Portugal
      • Lisbon, Portugal, 1099-023
        • IPO Lisboa FG, EPE /ID# 225072
  • Russia
    • Moscow
      • Moscow, Moscow, Russia, 115478
        • Federal State Budgetary Scientific Institution N.N. Blokhin /ID# 225194
    • Penza Oblast
      • Penza, Penza Oblast, Russia, 440071
        • Regional Oncological Dispensary /ID# 225195
  • South Korea
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, South Korea, 06351
        • Samsung Medical Center /ID# 240882
  • Spain
      • Madrid, Spain, 28040
        • Hospital Universitario Fundacion Jimenez Diaz /ID# 225476
  • Sweden
    • Skåne County
      • Lund, Skåne County, Sweden, 221 41
        • Duplicate_Skane University Hospital Lund /ID# 224747
  • Taiwan
      • Taichung, Taiwan, 40447
        • China Medical University Hospital /ID# 224945
    • Taipei
      • Taipei City, Taipei, Taiwan, 100
        • National Taiwan University Hospital /ID# 224946
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06590
        • Ankara Univ Medical Faculty /ID# 225043
      • Istanbul, Turkey (Türkiye), 34093
        • Istanbul University Istanbul Medical Faculty /ID# 225045
      • Istanbul, Turkey (Türkiye), 34365
        • Vehbi Koc vakfi Amerikan Hasta /ID# 225046
  • Ukraine
      • Dnipro, Ukraine, 49102
        • Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council /ID# 240575
  • United Kingdom
      • Blackpool, United Kingdom, FY3 8NR
        • Blackpool Teaching Hospitals NHS Foundation Trust /ID# 225163
      • Liverpool, United Kingdom, L7 8YA
        • Clatterbridge Cancer Centre - Liverpool /ID# 218736
      • Wolverhampton, United Kingdom, WV10 0QP
        • The Royal Wolverhampton NHS Trust /ID# 225164
    • Devon
      • Plymouth, Devon, United Kingdom, PL6 8DH
        • Derriford Hospital and the Royal Eye Infirmary /ID# 218731
    • England
      • Leicester, England, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary /ID# 240468
    • Greater London
      • London, Greater London, United Kingdom, NW1 2BU
        • University College London Hospital /ID# 240467
      • London, Greater London, United Kingdom, SE5 9RS
        • Kings College Hospital NHS Foundation Trust /ID# 218735
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • University Hospital Southampton NHS Foundation Trust /ID# 225161
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • University of Arizona Cancer Center - Tucson /ID# 210548
    • California
      • Los Angeles, California, United States, 90095
        • UCLA Santa Monica Hematology Oncology /ID# 210551
    • Illinois
      • Harvey, Illinois, United States, 60426
        • Ingalls Memorial Hosp /ID# 210553
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute /ID# 215360
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 231132
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center /ID# 210555
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Medical Center - Seattle /ID# 213120

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subject has been enrolled and dosed in an ongoing venetoclax study and continues to tolerate and derive benefit from the study drug.
  • Male subject agrees to refrain from sperm donation.
  • Female subjects must not be pregnant or breastfeeding.

Exclusion Criteria:

- None.

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Venetoclax
Venetoclax at the same dose administered to each subject during the previous study in which they were enrolled.
Drug: Venetoclax
oral; film-coated tablets or tablets for oral suspension
Other Names:
  • Venclexta
  • ABT-199

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events
Time Frame: From first dose of study drug until 30 days following last dose of study drug (up to approximately 5 years).
An adverse event (AE) is defined as any untoward medical occurrence in a subject 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. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.
From first dose of study drug until 30 days following last dose of study drug (up to approximately 5 years).

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: ABBVIE INC., 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 6, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 15, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M19-388
  • 2022-501522-38-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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