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Chronic Lymphocytic LeukemiaPhase 3NCT06428019

A Study to Evaluate the Risk of Tumor Lysis Syndrome (TLS) in Adult Participants Receiving Oral Venetoclax in Combination With Intravenously Infused Obinutuzumab or Oral Acalabrutinib for Previously Untreated Chronic Lymphocytic Leukemia (CLL)

A Phase 3 study testing Venetoclax, Acalabrutinib and Obinutuzumab in people with Chronic Lymphocytic Leukemia, run by AbbVie at 70 sites in 9 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess the safety of venetoclax in combination with obinutuzumab or acalabrutinib in the treatment of CLL. Adverse events and change in disease activity will be assessed. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
Venetoclax, Acalabrutinib and Obinutuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
70 sitesin 9 countries
Study dates
5 Aug 2024to Mar 2028
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of documented, previously untreated, chronic lymphocytic leukemia (CLL) requiring treatment according to the 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria and have a life expectancy of > 6 months.
  • Previously untreated small lymphocytic lymphoma (SLL) meeting the 2018 iwCLL criteria for treatment will also be equally considered as CLL for eligibility, screening, treatment and evaluation.
  • Eastern Cooperative Oncology Group (ECOG) performance status <= 2.
  • Adequate marrow function independent of growth factor or transfusion support within 2 weeks of screening, unless cytopenia is due to marrow involvement of CLL as listed in the protocol.
  • Creatinine clearance (CrCl) >= 30 mL/min using the Cockcroft-Gault formula are eligible for inclusion.

Who cannot join

  • Active/uncontrolled infection, no Richter's transformation, no active immune thrombocytopenia.

Trial locations and contacts

70 sites in 9 countries. Contact the study team or a site near you to ask about taking part.

ABBVIE CALL CENTER contact

844-663-3742

abbvieclinicaltrials@abbvie.com

70 sites in 9 countries

United States32 sites, 31 recruiting

  • Rocky Mountain Cancer Centers - Aurora /ID# 267549

    Aurora, Colorado, 80012

    Recruiting

  • Texas Oncology - Austin Midtown /ID# 268152

    Austin, Texas, 78705

    Recruiting

  • Center for Cancer and Blood Disorders-American Oncology Partners of Maryland /ID# 266445

    Bethesda, Maryland, 20817

    Recruiting

  • Atrium Health /ID# 267219

    Charlotte, North Carolina, 28204-2963

    Recruiting

  • Cleveland Clinic Main Campus /ID# 271292

    Cleveland, Ohio, 44195

    Recruiting

  • UCSF FRESNO/Community Cancer Institute /ID# 270874

    Clovis, California, 93611

    Recruiting

  • University of Texas - Southwestern Medical Center /ID# 266528

    Dallas, Texas, 75235

    Recruiting

  • University of Iowa Health Care /ID# 267206

    Des Moines, Iowa, 50314-3017

    Recruiting

  • Henry Ford Hospital /ID# 270973

    Detroit, Michigan, 48202

    Recruiting

  • Northwest Cancer Center - Dyer Clinic /ID# 268478

    Dyer, Indiana, 46311

    Recruiting

  • Willamette Valley Cancer Institute and Research Center /ID# 266326

    Eugene, Oregon, 97401

    Recruiting

  • Virginia Cancer Specialists - Fairfax /ID# 268155

    Fairfax, Virginia, 22031

    Recruiting

  • Malcolm Randall V.A. Medical Center /ID# 267825

    Gainesville, Florida, 32608

    Recruiting

  • Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 266713

    Jacksonville, Florida, 32256

    Recruiting

  • Saint Lukes Hospital of Kansas City /ID# 267270

    Kansas City, Missouri, 64111

    Recruiting

  • Valkyrie Clinical Trials /ID# 268151

    Los Angeles, California, 90067

    Recruiting

  • West Virginia University School of Medicine /ID# 267645

    Morgantown, West Virginia, 26506

    Recruiting

  • Yale University School of Medicine /ID# 266224

    New Haven, Connecticut, 06510

    Recruiting

  • Icahn School of Medicine at Mount Sinai /ID# 266328

    New York, New York, 10029

    Recruiting

  • Vista Oncology - East Olympia /ID# 267337

    Olympia, Washington, 98506

    Site Coordinator, 360-413-8880 opt 4

    Recruiting

  • Mid Florida Hematology And Oncology Center /ID# 269159

    Orange City, Florida, 32763

    Recruiting

  • Lifespan Cancer Institute - Providence /ID# 266550

    Providence, Rhode Island, 02903

    Recruiting

  • Willis-Knighton Medical Center /ID# 270569

    Shreveport, Louisiana, 71103

    Completed

  • Maryland Oncology Hematology - Silver Spring /ID# 267557

    Silver Spring, Maryland, 20904

    Recruiting

  • Springfield Clinic - First /ID# 270145

    Springfield, Illinois, 62702

    Recruiting

  • Comprehensive Hematology Oncology /ID# 267644

    St. Petersburg, Florida, 33709

    Recruiting

  • Northwest Medical Specialties Tacoma /ID# 266327

    Tacoma, Washington, 98405

    Recruiting

  • Arizona Oncology - Tucson - Rudasill /ID# 267552

    Tucson, Arizona, 85704

    Recruiting

  • Southern VA Health Care System /ID# 266254

    Tucson, Arizona, 85723

    Recruiting

  • Oklahoma Cancer Specialists and Research Institute /ID# 267643

    Tulsa, Oklahoma, 74146

    Recruiting

  • Atrium Health Wake Forest Baptist Medical Center /ID# 273142

    Winston-Salem, North Carolina, 27157

    Recruiting

  • UMass Memorial Medical Center /ID# 270023

    Worcester, Massachusetts, 01655

    Recruiting

Other trials in United States

France10 sites, 10 recruiting

  • CHU Amiens-Picardie Site Sud /ID# 266849

    Amiens, Somme, 80054

    Recruiting

  • Centre Hospitalier d Argenteuil Victor Dupouy /ID# 266322

    Argenteuil, Île-de-France Region, 95107

    Recruiting

  • Centre Hospitalier de la Côte Basque /ID# 266847

    Bayonne, Pyrenees-Atlantiques, 64109

    Recruiting

  • Centre Hospitalier Métropole Savoie - Site Hôpital de Chambéry /ID# 266854

    Chambéry, Savoie, 73007

    Recruiting

  • Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 266270

    Créteil, Paris, 94010

    Recruiting

  • Centre Hospitalier Régional Metz Thionville - Hôpital de Mercy /ID# 266852

    Metz, Moselle, 57085

    Recruiting

  • Centre Antoine-Lacassagne /ID# 266894

    Nice, Provence-Alpes-Côte d'Azur Region, 06189

    Recruiting

  • Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 266272

    Orléans, 45067

    Recruiting

  • Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 267438

    Paris, Paris, 75679

    Recruiting

  • Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 266319

    St-Priest-en-Jarez, Pays de la Loire Region, 42270

    Recruiting

Other trials in France

Serbia7 sites, 7 recruiting

  • Clinical Hospital Center Zvezdara /ID# 266560

    Belgrade, Beograd, 11000

    Recruiting

  • University Clinical Center Serbia /ID# 266579

    Belgrade, Beograd, 11000

    Recruiting

  • Clinical Hospital Center - Bežanijska Kosa /ID# 266567

    Belgrade, Beograd, 11080

    Recruiting

  • Institute for Oncology of Vojvodina /ID# 266556

    Kamenitz, Vojvodina, 21208

    Recruiting

  • University Clinical Center Kragujevac /ID# 266568

    Kragujevac, Sumadijski Okrug, 34000

    Recruiting

  • University Clinical Center Nis /ID# 266580

    Niš, Nisavski Okrug, 18300

    Recruiting

  • University Clinical Center Vojvodina /ID# 266674

    Novi Sad, 21000

    Recruiting

Other trials in Serbia

Spain6 sites, 6 recruiting

  • CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 266969

    Madrid, 28027

    Recruiting

  • Hospital MD Anderson Cancer Center Madrid /ID# 267167

    Madrid, 28033

    Recruiting

  • Hospital Universitario Puerta de Hierro - Majadahonda /ID# 266967

    Majadahonda, Madrid, 28222

    Recruiting

  • Clinica Universidad de Navarra - Pamplona /ID# 267762

    Pamplona, Navarre, 31008

    Recruiting

  • Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 267164

    Santiago de Compostela, A Coruna, 15706

    Recruiting

  • Hospital Universitario Virgen del Rocio /ID# 266968

    Seville, 41013

    Recruiting

Other trials in Spain

Greece5 sites, 5 recruiting

  • University General Hospital of Alexandroupoli /ID# 266816

    Alexandroupoli, Evros, 68100

    Recruiting

  • Evangelismos Hospital /ID# 266815

    Athens, Attica, 10676

    Recruiting

  • General Hospital of Athens Laiko /ID# 266813

    Athens, Attica, 11527

    Recruiting

  • University General Hospital Attikon /ID# 266814

    Athens, Attica, 12462

    Recruiting

  • Olympion General Clinic /ID# 266819

    Pátrai, Achaia, 26443

    Recruiting

Other trials in Greece

Australia4 sites, 4 recruiting

  • St Vincent's Hospital - Melbourne /ID# 270027

    Fitzroy, Victoria, 3065

    Recruiting

  • Royal Perth Hospital /ID# 266906

    Perth, Western Australia, 6000

    Recruiting

  • Townsville University Hospital /ID# 266954

    Townsville, Queensland, 4814

    Recruiting

  • Calvary Mater Newcastle /ID# 267408

    Waratah, New South Wales, 2298

    Recruiting

Other trials in Australia

Taiwan4 sites, 4 recruiting

  • Kaohsiung Chang Gung Memorial Hospital /ID# 267046

    Kaohsiung City, Kaohsiung, 833

    Recruiting

  • China Medical University Hospital /ID# 267018

    Taichung, 40447

    Recruiting

  • National Taiwan University Hospital /ID# 267017

    Taipei, 100

    Recruiting

  • Linkou Chang Gung Memorial Hospital /ID# 267045

    Taoyuan City, 333

    Recruiting

Other trials in Taiwan

Puerto Rico1 site, 1 recruiting

  • Pan American Center for Oncology Trials /ID# 266243

    Rio Piedras, 00935

    Recruiting

Other trials in Puerto Rico

United Kingdom1 site, 1 recruiting

  • Nottingham City Hospital /ID# 266991

    Nottingham, Nottinghamshire, NG5 1PB

    Recruiting

Other trials in United Kingdom

About this study

Official title: A Prospective, Open-Label, Phase IIb/III Study to Evaluate the Risk of TLS and Optimization of the Initiation of Venetoclax in Combination With Obinutuzumab or Acalabrutinib With Different Ramp- Up Periods in Previously Untreated Subjects With CLL

Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess the safety of venetoclax in combination with obinutuzumab or acalabrutinib in the treatment of CLL. Adverse events and change in disease activity will be assessed.

Venetoclax in combination with obinutuzumab or acalabrutinib is being investigated in the treatment of CLL. Study doctors put the participants in 1 of 4 groups, called treatment arms. Participants will receive oral venetoclax in combination with intravenously (IV) infused obinutuzumab or oral acalabrutinib at in different dosing schemes as part of treatment. Approximately 170 adult participants with CLL who are being treated with venetoclax will be enrolled in the study in approximately 80 sites worldwide.

Read more

Participants in Arm A will receive oral venetoclax in combination with IV infused obinutuzumab, with a 5 week venetoclax ramp up. Participants in Arm B will receive oral venetoclax in combination with oral acalabrutinib, with a 5 week venetoclax ramp up. Participants in Arm C and Arm D will receive oral venetoclax in combination with oral acalabrutinib, with differing venetoclax ramp up periods. The total study duration is approximately 28 months.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Being tested
Venetoclax, Acalabrutinib, Obinutuzumab
Keywords
Chronic Lymphocytic Leukemia, CLL, Venetoclax, ABT-199, Obinutuzumab, Acalabrutinib
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

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

  • VenetoclaxDrug

    Also called ABT-199

    Oral: Tablet

  • AcalabrutinibDrug

    Oral: Tablet

  • ObinutuzumabDrug

    Intravenous Infusion

Study groups in NCT06428019
Study groupRoleWhat they receive
Arm A: Venetoclax + ObinutuzumabExperimentalParticipants will receive venetoclax in combination with obinutuzumab, with a 5 week venetoclax ramp up.
Receives: Drug: Venetoclax; Drug: Obinutuzumab
Arm B: Venetoclax + AcalabrutinibExperimentalParticipants will receive venetoclax in combination with acalabrutinib, with a 5 week venetoclax ramp up.
Receives: Drug: Venetoclax; Drug: Acalabrutinib
Arm C: Venetoclax + AcalabrutinibExperimentalParticipants will receive venetoclax in combination with acalabrutinib, with a modified venetoclax ramp up A.
Receives: Drug: Venetoclax; Drug: Acalabrutinib
Arm D: Venetoclax + AcalabrutinibExperimentalParticipants will receive venetoclax in combination with acalabrutinib, with a modified venetoclax ramp up B.
Receives: Drug: Venetoclax; Drug: Acalabrutinib

What is being measured

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

  1. Part 1: Percentage of Participants with Treatment-Emergent Laboratory Tumor Lysis Syndrome (TLS)-Venetoclax

    TLS is defined per Howard criteria that require a clinical intervention per independent review committee (IRC) assessment during the venetoclax ramp-up period in previously untreated participants with chronic lymphocytic leukemia (CLL) achieving a medium tumor burden with creatinine clearance (CrCl) of at least 80 ml/min or low tumor burden (regardless of CrCl level) after debulking therapy.

    Measured: Up to 28 Months

  2. Part 1: Percentage of Participants with Hyperkalemia-Venetoclax

    Hyperkalemia (potassium >6.0 mmol/L) is defined per Howard criteria that require a clinical intervention per IRC assessment during the venetoclax ramp-up period in previously untreated participants with CLL achieving a medium tumor burden with CrCl of at least 80 ml/min or low tumor burden (regardless of CrCl level) after debulking therapy.

    Measured: Up to 28 Months

Secondary outcomes (5)

  1. Part 1: Percentage of Participants with Treatment-Emergent Laboratory TLS

    TLS is defined per Howard criteria that require a clinical intervention per IRC assessment, at each dose level and at each laboratory monitoring point during ramp-up period in previously untreated participants with CLL achieving a medium tumor burden with CrCl of at least 80 ml/min or low tumor burden (regardless of CrCl level) after debulking therapy.

    Measured: Up to 28 Months

  2. Part 1: Percentage of Participants with Hyperkalemia

    Hyperkalemia (potassium >6.0 mmol/L) is defined per Howard criteria that require a clinical intervention per independent review committee (IRC) assessment during the venetoclax ramp-up period in previously untreated participants with CLL achieving a medium tumor burden with CrCl of at least 80 ml/min or low tumor burden (regardless of CrCl level) after debulking therapy.

    Measured: Up to 28 Months

  3. Part 1: Percentage of Participants with Treatment-Emergent TLS-Related Events

    TLS-related events are defined as laboratory TLS per Howard criteria requiring clinical intervention per IRC assessment, hyperkalemia (potassium >6.0 mmol/L) requiring clinical intervention per IRC assessment, laboratory TLS per Howard criteria irrespective of clinical intervention, Hyperkalemia (potassium >6.0 mmol/L) irrespective of clinical intervention, clinical TLS per Howard criteria irrespective of clinical intervention, any single TLS-related lab abnormality requiring clinical intervention per Investigator.

    Measured: Up to 28 Months

  4. Part 1: Percentage of Participants with Adverse Events (AE) of TLS

    AEs of TLS is defined as a blood chemistry changes or symptom suggestive of TLS.

    Measured: Up to 28 Months

  5. Part 1: Percentage of Participants with Reduction of Tumor Burden from Baseline

    Percentage of participants with reduction of tumor burden.

    Measured: Up to 28 Months

Timeline

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

  1. First posted24 May 2024
  2. Study start5 Aug 2024
  3. Primary completionMar 2028 (estimated)
  4. Study completionMar 2028 (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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
170 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06428019
Sponsor's protocol ID
M24-287
Other IDs
2024-512147-23-00
Status last verified
Apr 2026
First submitted
20 May 2024
Last updated
9 Apr 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Venetoclax, Acalabrutinib and Obinutuzumab in people with Chronic Lymphocytic Leukemia, run by AbbVie at 70 sites in 9 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 5 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: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 70 sites in United States, France, Serbia, Spain, Greece and 4 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?

Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Percentage of Participants with Treatment-Emergent Laboratory Tumor Lysis Syndrome (TLS)-Venetoclax (time frame: Up to 28 Months). The study lists 2 primary outcomes in all. 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 NCT06428019.

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 9 Apr 2026.

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