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

Phase 3

Active, not recruiting

• Conditions: Chronic Lymphocytic Leukemia; Acute Myeloid Leukemia; Multiple Myeloma; Non-Hodgkin's Lymphoma; Acute Lymphoblastic Leukemia; Cancer
• Interventions: Drug: Venetoclax

• Registration Number: NCT03844048
• Lead Sponsor: AbbVie

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-15
• Study First Submitted QC: 2019-02-15
• Study First Posted: 2019-02-18
• Study Start: 2019-09-06
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-06
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 165

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Venetoclax	Venetoclax	Venetoclax at the same dose administered to each subject during the previous study in which they were enrolled.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	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.

Trial Locations

Locations (56)

Blackpool Teaching Hospitals NHS Foundation Trust /ID# 225163; 🇬🇧 Blackpool, United Kingdom

Clatterbridge Cancer Centre - Liverpool /ID# 218736; 🇬🇧 Liverpool, United Kingdom

King's College Hospital NHS Foundation Trust /ID# 218735; 🇬🇧 London, United Kingdom

The Royal Wolverhampton NHS Trust /ID# 225164; 🇬🇧 Wolverhampton, United Kingdom

University of Arizona Cancer Center - Tucson /ID# 210548; 🇺🇸 Tucson, Arizona, United States

UCLA Santa Monica Hematology Oncology /ID# 210551; 🇺🇸 Los Angeles, California, United States

Ingalls Memorial Hosp /ID# 210553; 🇺🇸 Harvey, Illinois, United States

Dana-Farber Cancer Institute /ID# 215360; 🇺🇸 Boston, Massachusetts, United States

University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 231132; 🇺🇸 Ann Arbor, Michigan, United States

Dartmouth-Hitchcock Medical Center - 1 Medical Center Drive /ID# 210555; 🇺🇸 Lebanon, New Hampshire, United States

Swedish Cancer Institute /ID# 213120; 🇺🇸 Seattle, Washington, United States

Royal Prince Alfred Hospital /ID# 239557; 🇦🇺 Camperdown, New South Wales, Australia

St George Hospital /ID# 225589; 🇦🇺 Kogarah, New South Wales, Australia

Liverpool Hospital /ID# 225591; 🇦🇺 Liverpool, New South Wales, Australia

Peter MacCallum Cancer Ctr /ID# 210559; 🇦🇺 Melbourne, Victoria, Australia

Fiona Stanley Hospital /ID# 239480; 🇦🇺 Murdoch, Western Australia, Australia

Perth Blood Institute Ltd /ID# 225592; 🇦🇺 Nedlands, Western Australia, Australia

Duplicate_Medizinische Universitaet Graz /ID# 223817; 🇦🇹 Graz, Steiermark, Austria

Cliniques Universitaires UCL Saint-Luc /ID# 224327; 🇧🇪 Bruxelles, Bruxelles-Capitale, Belgium

CHUQ- Hôpital de l'Enfant-Jesus /ID# 224616; 🇨🇦 Quebec City, Quebec, Canada

Rigshospitalet /ID# 224213; 🇩🇰 Copenhagen Ø, Hovedstaden, Denmark

Aarhus Universitetshospital - Skejby /ID# 224214; 🇩🇰 Aarhus, Midtjylland, Denmark

CHU Grenoble - Hopital Michallon /ID# 240497; 🇫🇷 La Tronche, Isere, France

HCL - Hopital Lyon Sud /ID# 213508; 🇫🇷 Pierre Benite CEDEX, Rhone, France

General Hospital of Athens Laiko /ID# 224087; 🇬🇷 Athens, Attiki, Greece

General Hospital of Thessaloniki George Papanikolaou /ID# 224088; 🇬🇷 Thessaloniki, Greece

Queen Mary Hospital /ID# 224944; 🇭🇰 Hong Kong, Hong Kong

Beaumont Hospital /ID# 225165; 🇮🇪 Dublin, Ireland

Kobe City Medical Center General Hospital /ID# 241518; 🇯🇵 Kobe-shi, Hyogo, Japan

Duplicate_National Hospital Organization Mito Medical Center /ID# 241986; 🇯🇵 Higashi Ibaraki-gun, Ibaraki, Japan

Okayama Medical Center /ID# 241517; 🇯🇵 Okayama-shi, Okayama, Japan

National Cancer Center Hospital /ID# 241516; 🇯🇵 Chuo-ku, Tokyo, Japan

Samsung Medical Center /ID# 240882; 🇰🇷 Seoul, Seoul Teugbyeolsi, Korea, Republic of

Centro de Investigacion Clínica Chapultepec SA de CV /ID# 227018; 🇲🇽 Morelia, Michoacan, Mexico

Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 227017; 🇲🇽 Monterrey, Nuevo Leon, Mexico

Aotearoa Clinical Trials /ID# 225596; 🇳🇿 Papatoetoe, Auckland, New Zealand

North Shore Hospital /ID# 225597; 🇳🇿 Takapuna, Auckland, New Zealand

Wellington Regional Hospital /ID# 225593; 🇳🇿 Newtown, Wellington, New Zealand

Duplicate_Pratia MCM Krakow /ID# 218561; 🇵🇱 Krakow, Malopolskie, Poland

Instytut Hematologii i Transfuzjologii /ID# 225478; 🇵🇱 Warszawa, Mazowieckie, Poland

SP ZOZ Zespol Szpitali Miejskich w Chorzowie /ID# 225474; 🇵🇱 Chorzow, Slaskie, Poland

IPO Lisboa FG, EPE /ID# 225072; 🇵🇹 Lisboa, Portugal

Federal State Budgetary Scientific Institution N.N. Blokhin /ID# 225194; 🇷🇺 Moscow, Moskva, Russian Federation

Regional Oncological Dispensary /ID# 225195; 🇷🇺 Penza, Penzenskaya Oblast, Russian Federation

Hospital Universitario Fundacion Jimenez Diaz /ID# 225476; 🇪🇸 Madrid, Spain

Duplicate_Skane University Hospital Lund /ID# 224747; 🇸🇪 Lund, Skane Lan, Sweden

National Taiwan University Hospital /ID# 224946; 🇨🇳 Taipei City, Taipei, Taiwan

China Medical University Hospital /ID# 224945; 🇨🇳 Taichung, Taiwan

Ankara Univ Medical Faculty /ID# 225043; 🇹🇷 Ankara, Turkey

Istanbul University Istanbul Medical Faculty /ID# 225045; 🇹🇷 Istanbul, Turkey

Vehbi Koc vakfi Amerikan Hasta /ID# 225046; 🇹🇷 Istanbul, Turkey

Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council /ID# 240575; 🇺🇦 Dnipro, Ukraine

Derriford Hospital and the Royal Eye Infirmary /ID# 218731; 🇬🇧 Plymouth, Devon, United Kingdom

Leicester Royal Infirmary /ID# 240468; 🇬🇧 Leicester, England, United Kingdom

University College London Hospital /ID# 240467; 🇬🇧 London, Greater London, United Kingdom

University Hospital Southampton NHS Foundation Trust /ID# 225161; 🇬🇧 Southampton, Hampshire, United Kingdom