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

NCT03844048 | Active Not Recruiting Phase 3 FDA Drug

• 2 other identifiers: M19-3882022-501522-38-00
• Study Type: interventional
• Target: 165
• Locations: 22 countries
• Sites: 55

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.

Conditions

Acute Lymphoblastic Leukemia; Chronic Lymphocytic Leukemia; Acute Myeloid Leukemia; Multiple Myeloma; Non-Hodgkin's Lymphoma; Cancer

Keywords

Chronic Lymphocytic Leukemia (CLL); Acute Myeloid Leukemia (AML); Multiple Myeloma (MM); Non-Hodgkin's Lymphoma (NHL); Acute Lymphoblastic Leukemia (ALL); Cancer; Venetoclax

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  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).

Study Arms (1)

Venetoclax

EXPERIMENTAL

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

Drug: Venetoclax

Interventions

Venetoclax DRUG

oral; film-coated tablets or tablets for oral suspension

Also known as: ABT-199, Venclexta

Venetoclax

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- None.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (56)

University of Arizona Cancer Center - Tucson /ID# 210548

Tucson, Arizona, 85724, United States

Location

UCLA Santa Monica Hematology Oncology /ID# 210551

Los Angeles, California, 90095, United States

Location

Ingalls Memorial Hosp /ID# 210553

Harvey, Illinois, 60426, United States

Location

Dana-Farber Cancer Institute /ID# 215360

Boston, Massachusetts, 02215, United States

Location

University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 231132

Ann Arbor, Michigan, 48109, United States

Location

Dartmouth-Hitchcock Medical Center /ID# 210555

Lebanon, New Hampshire, 03756, United States

Location

Swedish Medical Center - Seattle /ID# 213120

Seattle, Washington, 98104, United States

Location

Royal Prince Alfred Hospital /ID# 239557

Camperdown, New South Wales, 2050, Australia

Location

St George Hospital /ID# 225589

Kogarah, New South Wales, 2217, Australia

Location

Liverpool Hospital /ID# 225591

Liverpool, New South Wales, 2170, Australia

Location

Peter MacCallum Cancer Ctr /ID# 210559

Melbourne, Victoria, 3000, Australia

Location

Fiona Stanley Hospital /ID# 239480

Murdoch, Western Australia, 6150, Australia

Location

Perth Blood Institute Ltd /ID# 225592

Nedlands, Western Australia, 6009, Australia

Location

Duplicate_Medizinische Universitaet Graz /ID# 223817

Graz, Styria, 8010, Austria

Location

Cliniques Universitaires UCL Saint-Luc /ID# 224327

Brussels, Brussels Capital, 1200, Belgium

Location

CHUQ- Hôpital de l'Enfant-Jesus /ID# 224616

Québec, Quebec, G1J 1Z4, Canada

Location

Rigshospitalet /ID# 224213

Copenhagen Ø, Capital Region, 2100, Denmark

Location

Aarhus Universitetshospital - Skejby /ID# 224214

Aarhus, Central Jutland, 8200, Denmark

Location

CHU Grenoble - Hopital Michallon /ID# 240497

La Tronche, Isere, 38700, France

Location

HCL - Hopital Lyon Sud /ID# 213508

Pierre-Bénite, Rhone, 69495, France

Location

General Hospital of Athens Laiko /ID# 224087

Athens, Attica, 11527, Greece

Location

General Hospital of Thessaloniki George Papanikolaou /ID# 224088

Thessaloniki, 57010, Greece

Location

Queen Mary Hospital /ID# 224944

Hong Kong, 999077, Hong Kong

Location

Beaumont Hospital /ID# 225165

Dublin, D09 XR63, Ireland

Location

Kobe City Medical Center General Hospital /ID# 241518

Kobe, Hyōgo, 650-0047, Japan

Location

Duplicate_National Hospital Organization Mito Medical Center /ID# 241986

Higashi Ibaraki-gun, Ibaraki, 311-3193, Japan

Location

Duplicate_Okayama Medical Center /ID# 241517

Okayama, Okayama-ken, 701-1192, Japan

Location

National Cancer Center Hospital /ID# 241516

Chuo-ku, Tokyo, 104-0045, Japan

Location

Centro de Investigacion Clínica Chapultepec SA de CV /ID# 227018

Morelia, Michoacán, 58260, Mexico

Location

Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 227017

Monterrey, Nuevo León, 64460, Mexico

Location

Aotearoa Clinical Trials /ID# 225596

Papatoetoe, Auckland, 2025, New Zealand

Location

North Shore Hospital /ID# 225597

Takapuna, Auckland, 0622, New Zealand

Location

Wellington Regional Hospital /ID# 225593

Newtown, Wellington Region, 6021, New Zealand

Location

Duplicate_Pratia MCM Krakow /ID# 218561

Krakow, Lesser Poland Voivodeship, 30-727, Poland

Location

Instytut Hematologii i Transfuzjologii /ID# 225478

Warsaw, Masovian Voivodeship, 02-776, Poland

Location

SP ZOZ Zespol Szpitali Miejskich w Chorzowie /ID# 225474

Chorzów, Silesian Voivodeship, 41-500, Poland

Location

IPO Lisboa FG, EPE /ID# 225072

Lisbon, 1099-023, Portugal

Location

Federal State Budgetary Scientific Institution N.N. Blokhin /ID# 225194

Moscow, Moscow, 115478, Russia

Location

Regional Oncological Dispensary /ID# 225195

Penza, Penza Oblast, 440071, Russia

Location

Samsung Medical Center /ID# 240882

Seoul, Seoul Teugbyeolsi, 06351, South Korea

Location

Hospital Universitario Fundacion Jimenez Diaz /ID# 225476

Madrid, 28040, Spain

Location

Duplicate_Skane University Hospital Lund /ID# 224747

Lund, Skåne County, 221 41, Sweden

Location

National Taiwan University Hospital /ID# 224946

Taipei City, Taipei, 100, Taiwan

Location

China Medical University Hospital /ID# 224945

Taichung, 40447, Taiwan

Location

Ankara Univ Medical Faculty /ID# 225043

Ankara, 06590, Turkey (Türkiye)

Location

Istanbul University Istanbul Medical Faculty /ID# 225045

Istanbul, 34093, Turkey (Türkiye)

Location

Vehbi Koc vakfi Amerikan Hasta /ID# 225046

Istanbul, 34365, Turkey (Türkiye)

Location

Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council /ID# 240575

Dnipro, 49102, Ukraine

Location

Derriford Hospital and the Royal Eye Infirmary /ID# 218731

Plymouth, Devon, PL6 8DH, United Kingdom

Location

Leicester Royal Infirmary /ID# 240468

Leicester, England, LE1 5WW, United Kingdom

Location

University College London Hospital /ID# 240467

London, Greater London, NW1 2BU, United Kingdom

Location

Kings College Hospital NHS Foundation Trust /ID# 218735

London, Greater London, SE5 9RS, United Kingdom

Location

University Hospital Southampton NHS Foundation Trust /ID# 225161

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Blackpool Teaching Hospitals NHS Foundation Trust /ID# 225163

Blackpool, FY3 8NR, United Kingdom

Location

Clatterbridge Cancer Centre - Liverpool /ID# 218736

Liverpool, L7 8YA, United Kingdom

Location

The Royal Wolverhampton NHS Trust /ID# 225164

Wolverhampton, WV10 0QP, United Kingdom

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myeloid, Acute; Multiple Myeloma; Lymphoma, Non-Hodgkin; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Neoplasms

Interventions

venetoclax

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Myeloid; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Lymphoma

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: February 18, 2019
• Study Start: September 6, 2019
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

IE (1); AU (6); GR (2); DK (2); ME (2); JP (4); FR (2); PL (3); HK (1); NZ (3); SE (1); TW (2); TU (3); UA (1); KR (1); GB (8); CA (1); RU (2); BE (1); PT (1); US (7); ES (1)