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Active, not recruitingNCT03844048Updated May 13, 2026

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

A Phase 3 interventional study of Venetoclax in Chronic Lymphocytic Leukemia, Acute Myeloid Leukemia and Multiple Myeloma, sponsored by AbbVie. Active, not recruiting at 56 sites in 23 countries. Per ClinicalTrials.gov, last updated 2026-05-13.

Sponsored by AbbVie · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
165
Allocation
Not applicable
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • Chronic Lymphocytic Leukemia (CLL)
  • Acute Myeloid Leukemia (AML)
  • Multiple Myeloma (MM)
  • Non-Hodgkin's Lymphoma (NHL)
  • Acute Lymphoblastic Leukemia (ALL)
  • Cancer
  • Venetoclax
03

In context

Leukemia, Lymphocytic, Chronic, B-Cell

1,603 studies on the registry are indexed under Leukemia, Lymphocytic, Chronic, B-Cell; 243 are open to participants now.

This study's enrollment of 165 is above the median of 40 across 1,325 interventional studies indexed under Leukemia, Lymphocytic, Chronic, B-Cell.

Browse Leukemia, Lymphocytic, Chronic, B-Cell 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.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

- None.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
165 participants (actual)

Study arms

  • Experimental
    Venetoclax

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

    Drug: Venetoclax

Interventions

  • DrugVenetoclax

    oral; film-coated tablets or tablets for oral suspension

    Also known as: ABT-199, Venclexta

06

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 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.

    Time frame: From first dose of study drug until 30 days following last dose of study drug (up to approximately 5 years).

07

Study locations

56 sites
  • University of Arizona Cancer Center - Tucson /ID# 210548
    Tucson, Arizona 85724, United States
  • UCLA Santa Monica Hematology Oncology /ID# 210551
    Los Angeles, California 90095, United States
  • Ingalls Memorial Hosp /ID# 210553
    Harvey, Illinois 60426, United States
  • Dana-Farber Cancer Institute /ID# 215360
    Boston, Massachusetts 02215, United States
  • University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 231132
    Ann Arbor, Michigan 48109, United States
  • Dartmouth-Hitchcock Medical Center /ID# 210555
    Lebanon, New Hampshire 03756, United States
  • Swedish Medical Center - Seattle /ID# 213120
    Seattle, Washington 98104, United States
  • Royal Prince Alfred Hospital /ID# 239557
    Camperdown, New South Wales 2050, Australia
  • St George Hospital /ID# 225589
    Kogarah, New South Wales 2217, Australia
  • Liverpool Hospital /ID# 225591
    Liverpool, New South Wales 2170, Australia
  • Peter MacCallum Cancer Ctr /ID# 210559
    Melbourne, Victoria 3000, Australia
  • Fiona Stanley Hospital /ID# 239480
    Murdoch, Western Australia 6150, Australia
  • Perth Blood Institute Ltd /ID# 225592
    Nedlands, Western Australia 6009, Australia
  • Duplicate_Medizinische Universitaet Graz /ID# 223817
    Graz, Styria 8010, Austria
  • Cliniques Universitaires UCL Saint-Luc /ID# 224327
    Brussels, Brussels Capital 1200, Belgium
  • CHUQ- Hôpital de l'Enfant-Jesus /ID# 224616
    Québec, Quebec G1J 1Z4, Canada
  • Rigshospitalet /ID# 224213
    Copenhagen Ø, Capital Region 2100, Denmark
  • Aarhus Universitetshospital - Skejby /ID# 224214
    Aarhus, Central Jutland 8200, Denmark
  • CHU Grenoble - Hopital Michallon /ID# 240497
    La Tronche, Isere 38700, France
  • HCL - Hopital Lyon Sud /ID# 213508
    Pierre-Bénite, Rhone 69495, France
  • General Hospital of Athens Laiko /ID# 224087
    Athens, Attica 11527, Greece
  • General Hospital of Thessaloniki George Papanikolaou /ID# 224088
    Thessaloniki, 57010, Greece
  • Queen Mary Hospital /ID# 224944
    Hong Kong, 999077, Hong Kong
  • Beaumont Hospital /ID# 225165
    Dublin, D09 XR63, Ireland
  • Kobe City Medical Center General Hospital /ID# 241518
    Kobe, Hyōgo 650-0047, Japan
  • Duplicate_National Hospital Organization Mito Medical Center /ID# 241986
    Higashi Ibaraki-gun, Ibaraki 311-3193, Japan
  • Duplicate_Okayama Medical Center /ID# 241517
    Okayama, Okayama-ken 701-1192, Japan
  • National Cancer Center Hospital /ID# 241516
    Chuo-ku, Tokyo 104-0045, Japan
  • Centro de Investigacion Clínica Chapultepec SA de CV /ID# 227018
    Morelia, Michoacán 58260, Mexico
  • Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 227017
    Monterrey, Nuevo León 64460, Mexico
  • Aotearoa Clinical Trials /ID# 225596
    Papatoetoe, Auckland 2025, New Zealand
  • North Shore Hospital /ID# 225597
    Takapuna, Auckland 0622, New Zealand
  • Wellington Regional Hospital /ID# 225593
    Newtown, Wellington Region 6021, New Zealand
  • Duplicate_Pratia MCM Krakow /ID# 218561
    Krakow, Lesser Poland Voivodeship 30-727, Poland
  • Instytut Hematologii i Transfuzjologii /ID# 225478
    Warsaw, Masovian Voivodeship 02-776, Poland
  • SP ZOZ Zespol Szpitali Miejskich w Chorzowie /ID# 225474
    Chorzów, Silesian Voivodeship 41-500, Poland
  • IPO Lisboa FG, EPE /ID# 225072
    Lisbon, 1099-023, Portugal
  • Federal State Budgetary Scientific Institution N.N. Blokhin /ID# 225194
    Moscow, Moscow 115478, Russia
  • Regional Oncological Dispensary /ID# 225195
    Penza, Penza Oblast 440071, Russia
  • Samsung Medical Center /ID# 240882
    Seoul, Seoul Teugbyeolsi 06351, South Korea
  • Hospital Universitario Fundacion Jimenez Diaz /ID# 225476
    Madrid, 28040, Spain
  • Duplicate_Skane University Hospital Lund /ID# 224747
    Lund, Skåne County 221 41, Sweden
  • National Taiwan University Hospital /ID# 224946
    Taipei City, Taipei 100, Taiwan
  • China Medical University Hospital /ID# 224945
    Taichung, 40447, Taiwan
  • Ankara Univ Medical Faculty /ID# 225043
    Ankara, 06590, Turkey (Türkiye)
  • Istanbul University Istanbul Medical Faculty /ID# 225045
    Istanbul, 34093, Turkey (Türkiye)
  • Vehbi Koc vakfi Amerikan Hasta /ID# 225046
    Istanbul, 34365, Turkey (Türkiye)
  • Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council /ID# 240575
    Dnipro, 49102, Ukraine
  • Derriford Hospital and the Royal Eye Infirmary /ID# 218731
    Plymouth, Devon PL6 8DH, United Kingdom
  • Leicester Royal Infirmary /ID# 240468
    Leicester, England LE1 5WW, United Kingdom
  • University College London Hospital /ID# 240467
    London, Greater London NW1 2BU, United Kingdom
  • Kings College Hospital NHS Foundation Trust /ID# 218735
    London, Greater London SE5 9RS, United Kingdom
  • University Hospital Southampton NHS Foundation Trust /ID# 225161
    Southampton, Hampshire SO16 6YD, United Kingdom
  • Blackpool Teaching Hospitals NHS Foundation Trust /ID# 225163
    Blackpool, FY3 8NR, United Kingdom
  • Clatterbridge Cancer Centre - Liverpool /ID# 218736
    Liverpool, L7 8YA, United Kingdom
  • The Royal Wolverhampton NHS Trust /ID# 225164
    Wolverhampton, WV10 0QP, United Kingdom
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03844048
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Feb 18, 2019
Start date
Sep 6, 2019
Primary completion
Aug 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
May 13, 2026

Study contacts

ABBVIE INC.
study director · AbbVie

Oversight

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

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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