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Chronic Lymphocytic LeukemiaPhase 3NCT03844048

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

A Phase 3 study testing Venetoclax in people with Chronic Lymphocytic Leukemia and Acute Myeloid Leukemia, run by AbbVie at 56 sites in 23 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age
What is being tested?
Venetoclax
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
165 participants
Where
56 sitesin 23 countries
Study dates
6 Sep 2019to Aug 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • None.

Trial locations and contacts

56 sites in 23 countries.

56 sites in 23 countries

United Kingdom8 sites

  • Blackpool Teaching Hospitals NHS Foundation Trust /ID# 225163

    Blackpool, FY3 8NR

  • Leicester Royal Infirmary /ID# 240468

    Leicester, England, LE1 5WW

  • Clatterbridge Cancer Centre - Liverpool /ID# 218736

    Liverpool, L7 8YA

  • University College London Hospital /ID# 240467

    London, Greater London, NW1 2BU

  • Kings College Hospital NHS Foundation Trust /ID# 218735

    London, Greater London, SE5 9RS

  • Derriford Hospital and the Royal Eye Infirmary /ID# 218731

    Plymouth, Devon, PL6 8DH

  • University Hospital Southampton NHS Foundation Trust /ID# 225161

    Southampton, Hampshire, SO16 6YD

  • The Royal Wolverhampton NHS Trust /ID# 225164

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

United States7 sites

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

    Ann Arbor, Michigan, 48109

  • Dana-Farber Cancer Institute /ID# 215360

    Boston, Massachusetts, 02215

  • Ingalls Memorial Hosp /ID# 210553

    Harvey, Illinois, 60426

  • Dartmouth-Hitchcock Medical Center /ID# 210555

    Lebanon, New Hampshire, 03756

  • UCLA Santa Monica Hematology Oncology /ID# 210551

    Los Angeles, California, 90095

  • Swedish Medical Center - Seattle /ID# 213120

    Seattle, Washington, 98104

  • University of Arizona Cancer Center - Tucson /ID# 210548

    Tucson, Arizona, 85724

Other trials in United States

Australia6 sites

  • Royal Prince Alfred Hospital /ID# 239557

    Camperdown, New South Wales, 2050

  • St George Hospital /ID# 225589

    Kogarah, New South Wales, 2217

  • Liverpool Hospital /ID# 225591

    Liverpool, New South Wales, 2170

  • Peter MacCallum Cancer Ctr /ID# 210559

    Melbourne, Victoria, 3000

  • Fiona Stanley Hospital /ID# 239480

    Murdoch, Western Australia, 6150

  • Perth Blood Institute Ltd /ID# 225592

    Nedlands, Western Australia, 6009

Other trials in Australia

Japan4 sites

  • National Cancer Center Hospital /ID# 241516

    Chuo-ku, Tokyo, 104-0045

  • Duplicate_National Hospital Organization Mito Medical Center /ID# 241986

    Higashi Ibaraki-gun, Ibaraki, 311-3193

  • Kobe City Medical Center General Hospital /ID# 241518

    Kobe, Hyōgo, 650-0047

  • Duplicate_Okayama Medical Center /ID# 241517

    Okayama, Okayama-ken, 701-1192

Other trials in Japan

New Zealand3 sites

  • Wellington Regional Hospital /ID# 225593

    Newtown, Wellington Region, 6021

  • Aotearoa Clinical Trials /ID# 225596

    Papatoetoe, Auckland, 2025

  • North Shore Hospital /ID# 225597

    Takapuna, Auckland, 0622

Other trials in New Zealand

Poland3 sites

  • SP ZOZ Zespol Szpitali Miejskich w Chorzowie /ID# 225474

    Chorzów, Silesian Voivodeship, 41-500

  • Duplicate_Pratia MCM Krakow /ID# 218561

    Krakow, Lesser Poland Voivodeship, 30-727

  • Instytut Hematologii i Transfuzjologii /ID# 225478

    Warsaw, Masovian Voivodeship, 02-776

Other trials in Poland

Turkey (Türkiye)3 sites

  • Ankara Univ Medical Faculty /ID# 225043

    Ankara, 06590

  • Istanbul University Istanbul Medical Faculty /ID# 225045

    Istanbul, 34093

  • Vehbi Koc vakfi Amerikan Hasta /ID# 225046

    Istanbul, 34365

Other trials in Turkey (Türkiye)

Denmark2 sites

  • Aarhus Universitetshospital - Skejby /ID# 224214

    Aarhus, Central Jutland, 8200

  • Rigshospitalet /ID# 224213

    Copenhagen Ø, Capital Region, 2100

Other trials in Denmark

France2 sites

  • CHU Grenoble - Hopital Michallon /ID# 240497

    La Tronche, Isere, 38700

  • HCL - Hopital Lyon Sud /ID# 213508

    Pierre-Bénite, Rhone, 69495

Other trials in France

Greece2 sites

  • General Hospital of Athens Laiko /ID# 224087

    Athens, Attica, 11527

  • General Hospital of Thessaloniki George Papanikolaou /ID# 224088

    Thessaloniki, 57010

Other trials in Greece

Mexico2 sites

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 227017

    Monterrey, Nuevo León, 64460

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

    Morelia, Michoacán, 58260

Other trials in Mexico

Russia2 sites

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

    Moscow, Moscow, 115478

  • Regional Oncological Dispensary /ID# 225195

    Penza, Penza Oblast, 440071

Other trials in Russia

Taiwan2 sites

  • China Medical University Hospital /ID# 224945

    Taichung, 40447

  • National Taiwan University Hospital /ID# 224946

    Taipei City, Taipei, 100

Other trials in Taiwan

Austria1 site

  • Duplicate_Medizinische Universitaet Graz /ID# 223817

    Graz, Styria, 8010

Other trials in Austria

Belgium1 site

  • Cliniques Universitaires UCL Saint-Luc /ID# 224327

    Brussels, Brussels Capital, 1200

Other trials in Belgium

Canada1 site

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

    Québec, Quebec, G1J 1Z4

Other trials in Canada

Hong Kong1 site

  • Queen Mary Hospital /ID# 224944

    Hong Kong, 999077

Other trials in Hong Kong

Ireland1 site

  • Beaumont Hospital /ID# 225165

    Dublin, D09 XR63

Other trials in Ireland

Portugal1 site

  • IPO Lisboa FG, EPE /ID# 225072

    Lisbon, 1099-023

Other trials in Portugal

South Korea1 site

  • Samsung Medical Center /ID# 240882

    Seoul, Seoul Teugbyeolsi, 06351

Other trials in South Korea

Spain1 site

  • Hospital Universitario Fundacion Jimenez Diaz /ID# 225476

    Madrid, 28040

Other trials in Spain

Sweden1 site

  • Duplicate_Skane University Hospital Lund /ID# 224747

    Lund, Skåne County, 221 41

Other trials in Sweden

Ukraine1 site

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

    Dnipro, 49102

Other trials in Ukraine

About this study

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.

Being tested
Venetoclax
Keywords
Chronic Lymphocytic Leukemia (CLL), Acute Myeloid Leukemia (AML), Multiple Myeloma (MM), Non-Hodgkin's Lymphoma (NHL), Acute Lymphoblastic Leukemia (ALL), Cancer, Venetoclax
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Myeloid, Acute, Multiple Myeloma, Lymphoma, Non-Hodgkin, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VenetoclaxDrug

    Also called ABT-199, Venclexta

    oral; film-coated tablets or tablets for oral suspension

Study groups in NCT03844048
Study groupRoleWhat they receive
VenetoclaxExperimentalVenetoclax at the same dose administered to each subject during the previous study in which they were enrolled.
Receives: Drug: Venetoclax

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2019
  2. Study start6 Sep 2019
  3. Primary completionAug 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
165 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03844048
Sponsor's protocol ID
M19-388
Other IDs
2022-501522-38-00
Status last verified
May 2026
First submitted
15 Feb 2019
Last updated
13 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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.
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Venetoclax in people with Chronic Lymphocytic Leukemia and Acute Myeloid Leukemia, run by AbbVie at 56 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in United Kingdom, United States, Australia, Japan, New Zealand and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03844048.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.

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