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

December 20, 2023 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

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

165

Phase

  • Phase 3

Expanded Access

Available 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
    • Steiermark
      • Graz, Steiermark, Austria, 8010
        • Medizinische Universitaet Graz /ID# 223817
  • Belgium
    • Bruxelles-Capitale
      • Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
        • UCL Saint-Luc /ID# 224327
  • Canada
    • Quebec
      • Quebec City, Quebec, Canada, G1J 1Z4
        • CHUQ- Hôpital de l'Enfant-Jesus /ID# 224616
  • Denmark
    • Hovedstaden
      • Copenhagen Ø, Hovedstaden, Denmark, 2100
        • Rigshospitalet /ID# 224213
    • Midtjylland
      • Aarhus N, Midtjylland, Denmark, 8200
        • Aarhus University Hospital /ID# 224214
  • France
      • La Tronche, France, 38700
        • CHU Grenoble - Hopital Michallon /ID# 240497
    • Rhone
      • Pierre Benite CEDEX, Rhone, France, 69495
        • HCL - Hopital Lyon Sud /ID# 213508
  • Greece
      • Thessaloniki, Greece, 57010
        • General Hospital of Thessaloniki George Papanikolaou /ID# 224088
    • Attiki
      • Athens, Attiki, Greece, 11527
        • General Hospital of Athens Laiko /ID# 224087
  • Hong Kong
      • Hong Kong, Hong Kong, 999077
        • Queen Mary Hospital /ID# 224944
  • Ireland
    • Dublin
      • Beaumont, Dublin, Ireland, D09 XR63
        • Beaumont Hospital /ID# 225165
  • Japan
    • Hyogo
      • Kobe-shi, Hyogo, Japan, 650-0047
        • Kobe City Medical Center General Hospital /ID# 241518
    • Ibaraki
      • Higashi Ibaraki-gun, Ibaraki, Japan, 311-3193
        • National Hospital Organization Mito Medical Center /ID# 241986
    • Okayama
      • Okayama-shi, Okayama, Japan, 701-1192
        • Okayama Medical Center /ID# 241517
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital /ID# 241516
  • Korea, Republic of
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center /ID# 240882
  • Mexico
    • Michoacan
      • Morelia, Michoacan, Mexico, 58260
        • Centro de Investigacion Clínica Chapultepec SA de CV /ID# 227018
    • Nuevo Leon
      • Monterrey, Nuevo Leon, 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
      • Newtown, Wellington, New Zealand, 6021
        • Wellington Regional Hospital /ID# 225593
  • Poland
    • Malopolskie
      • Krakow, Malopolskie, Poland, 30-727
        • Pratia MCM Krakow /ID# 218561
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 02-776
        • Instytut Hematologii i Transfuzjologii /ID# 225478
    • Slaskie
      • Chorzow, Slaskie, Poland, 41-500
        • SP ZOZ Zespol Szpitali Miejskich w Chorzowie /ID# 225474
  • Portugal
      • Lisboa, Portugal, 1099-023
        • IPO Lisboa FG, EPE /ID# 225072
  • Russian Federation
    • Moskva
      • Moscow, Moskva, Russian Federation, 115478
        • Federal State Budgetary Scientific Institution N.N. Blokhin /ID# 225194
    • Penzenskaya Oblast
      • Penza, Penzenskaya Oblast, Russian Federation, 440071
        • Regional Oncological Dispensary /ID# 225195
  • Spain
      • Madrid, Spain, 28040
        • Hospital Universitario Fundacion Jimenez Diaz /ID# 225476
  • Sweden
    • Skane Lan
      • Lund, Skane Lan, Sweden, SE 221 41
        • Skane University Hospital Lund /ID# 224747
  • Taiwan
      • Taichung, Taiwan, 40447
        • China Medical University Hospital /ID# 224945
      • Taipei City, Taiwan, 100
        • National Taiwan University Hospital /ID# 224946
  • Turkey
      • Ankara, Turkey, 06590
        • Ankara Univ Medical Faculty /ID# 225043
      • Istanbul, Turkey, 34093
        • Istanbul University Istanbul Medical Faculty /ID# 225045
      • Istanbul, Turkey, 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
        • The Clatterbridge Cancer Centre NHS Foundation Trust /ID# 218736
      • London, United Kingdom, NW1 2PG
        • University College London Hospitals NHS Foundation Trust /ID# 240467
      • London, United Kingdom, SE5 9RS
        • King's College Hospital NHS Foundation Trust /ID# 218735
      • Plymouth, United Kingdom, PL6 5FP
        • University Hospital Plymouth NHS Trust /ID# 218731
      • Wolverhampton, United Kingdom, WV10 0QP
        • The Royal Wolverhampton NHS Trust /ID# 225164
    • England
      • Leicester, England, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary /ID# 240468
    • 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 Cancer Institute /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

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
Intervention / Treatment
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

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

AbbVie

Investigators

  • 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)

September 6, 2019

Primary Completion (Estimated)

May 27, 2025

Study Completion (Estimated)

May 27, 2025

Study Registration Dates

First Submitted

February 15, 2019

First Submitted That Met QC Criteria

February 15, 2019

First Posted (Actual)

February 18, 2019

Study Record Updates

Last Update Posted (Actual)

December 22, 2023

Last Update Submitted That Met QC Criteria

December 20, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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 data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

IPD Sharing Time Frame

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

IPD Sharing Access Criteria

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on 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
  • CSR

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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