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)

Last updated: August 22, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

3

Condition

Chronic Lymphocytic Leukemia

Lymphoproliferative Disorders

Leukemia

Treatment

Venetoclax

Acalabrutinib

Obinutuzumab

Clinical Study ID

NCT06428019
M24-287
2024-512147-23-00
  • Ages > 18
  • All Genders

Study 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.

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 120 adult participants with CLL who are being treated with venetoclax will be enrolled in the study in approximately 80 sites worldwide.

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of documented, previously untreated, chronic lymphocytic leukemia (CLL)requiring treatment according to the 2018 international workshop on chroniclymphocytic leukemia (iwCLL) criteria and have a life expectancy of > 6 months.

  • Previously untreated small lymphocytic lymphoma (SLL) meeting the 2018 iwCLLcriteria 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 listedin the protocol.

  • Creatinine clearance (CrCl) >= 30 mL/min using the Cockcroft-Gault formula areeligible for inclusion.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 120
Treatment Group(s): 3
Primary Treatment: Venetoclax
Phase: 3
Study Start date:
August 05, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Calvary Mater Newcastle /ID# 267408

    Waratah, New South Wales 2298
    Australia

    Site Not Available

  • Calvary Mater Newcastle /ID# 267408

    Waratah 10103871, New South Wales 2155400 2298
    Australia

    Active - Recruiting

  • Townsville University Hospital /ID# 266954

    Townsville, Queensland 4814
    Australia

    Site Not Available

  • Townsville University Hospital /ID# 266954

    Townsville 2146142, Queensland 2152274 4814
    Australia

    Active - Recruiting

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

    Fitzroy, Victoria 3065
    Australia

    Site Not Available

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

    Fitzroy 2166584, Victoria 2145234 3065
    Australia

    Active - Recruiting

  • Royal Perth Hospital /ID# 266906

    Perth, Western Australia 6000
    Australia

    Site Not Available

  • Royal Perth Hospital /ID# 266906

    Perth 2063523, Western Australia 2058645 6000
    Australia

    Active - Recruiting

  • Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord /ID# 266319

    St-Priest-en-Jarez, Loire 42270
    France

    Active - Recruiting

  • CHR Metz-Thionville - Hôpital de Mercy /ID# 266852

    Ars Laquenexy, Moselle 57530
    France

    Site Not Available

  • CHR Metz-Thionville - Hôpital de Mercy /ID# 266852

    Ars-Laquenexy 3036715, Moselle 57530
    France

    Active - Recruiting

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

    Creteil, Paris 94010
    France

    Site Not Available

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

    Créteil 3022530, Paris 94010
    France

    Active - Recruiting

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

    Paris 2988507, Paris 75679
    France

    Active - Recruiting

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

    Paris CEDEX 14, Paris 75679
    France

    Site Not Available

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

    St-Priest-en-Jarez, Pays de la Loire Region 2988289 42270
    France

    Active - Recruiting

  • Centre Antoine-Lacassagne /ID# 266894

    Nice, Provence-Alpes-Cote-d Azur 06189
    France

    Site Not Available

  • Centre Antoine-Lacassagne /ID# 266894

    Nice 2990440, Provence-Alpes-Côte d'Azur Region 2985244 06189
    France

    Active - Recruiting

  • Centre Hospitalier de la Côte Basque /ID# 266847

    Bayonne, Pyrenees-Atlantiques 64109
    France

    Site Not Available

  • Centre Hospitalier de la Côte Basque /ID# 266847

    Bayonne 3034475, Pyrenees-Atlantiques 64109
    France

    Active - Recruiting

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

    Chambery CEDEX, Savoie 73007
    France

    Site Not Available

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

    Chambéry 3027422, Savoie 73007
    France

    Active - Recruiting

  • CHU d'Amiens-Picardie - Hôpital Sud /ID# 266849

    Amiens 3037854, Somme 80054
    France

    Active - Recruiting

  • CHU d'Amiens-Picardie - Hôpital Sud /ID# 266849

    Amiens CEDEX 1, Somme 80054
    France

    Site Not Available

  • Centre Hospitalier d Argenteuil Victor Dupouy /ID# 266322

    Argenteuil 3037044, Île-de-France Region 3012874 95107
    France

    Active - Recruiting

  • Centre Hospitalier d'Argenteuil Victor Dupouy /ID# 266322

    Argenteuil, 95107
    France

    Site Not Available

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

    Orléans, 45067
    France

    Site Not Available

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

    Orléans 2989317, 45067
    France

    Active - Recruiting

  • Olympion General Clinic /ID# 266819

    Patras, Achaia 25443
    Greece

    Site Not Available

  • Olympion General Clinic /ID# 266819

    Pátrai 255683, Achaia 25443
    Greece

    Active - Recruiting

  • Evangelismos Hospital /ID# 266815

    Athens 264371, Attica 6692632 10676
    Greece

    Active - Recruiting

  • General Hospital of Athens Laiko /ID# 266813

    Athens 264371, Attica 6692632 11527
    Greece

    Active - Recruiting

  • University General Hospital Attikon /ID# 266814

    Athens 264371, Attica 6692632 12462
    Greece

    Active - Recruiting

  • Evangelismos Hospital /ID# 266815

    Athens, Attiki 10676
    Greece

    Active - Recruiting

  • General Hospital of Athens Laiko /ID# 266813

    Athens, Attiki 11527
    Greece

    Site Not Available

  • University General Hospital Attikon /ID# 266814

    Athens, Attiki 12462
    Greece

    Active - Recruiting

  • University General Hospital of Alexandroupoli /ID# 266816

    Alexandroupoli, Evros 68100
    Greece

    Site Not Available

  • University General Hospital of Alexandroupoli /ID# 266816

    Alexandroupoli 736928, Evros 68100
    Greece

    Active - Recruiting

  • Pan American Center for Oncology Trials /ID# 266243

    Rio Piedras, 00935
    Puerto Rico

    Site Not Available

  • Pan American Center for Oncology Trials /ID# 266243

    Rio Piedras 4829037, 00935
    Puerto Rico

    Active - Recruiting

  • Clinical Hospital Center - Bežanijska Kosa /ID# 266567

    Belgrade, Beograd 11080
    Serbia

    Active - Recruiting

  • Clinical Hospital Center Zvezdara /ID# 266560

    Belgrade, Beograd 11000
    Serbia

    Site Not Available

  • University Clinical Center Serbia /ID# 266579

    Belgrade, Beograd 11000
    Serbia

    Active - Recruiting

  • Clinical Hospital Center - Bežanijska Kosa /ID# 266567

    Belgrade 792680, Beograd 11080
    Serbia

    Active - Recruiting

  • Clinical Hospital Center Zvezdara /ID# 266560

    Belgrade 792680, Beograd 11000
    Serbia

    Active - Recruiting

  • University Clinical Center Serbia /ID# 266579

    Belgrade 792680, Beograd 11000
    Serbia

    Active - Recruiting

  • University Clinical Center Nis /ID# 266580

    Niš, Nisavski Okrug 18300
    Serbia

    Site Not Available

  • University Clinical Center Nis /ID# 266580

    Niš 787657, Nisavski Okrug 18300
    Serbia

    Active - Recruiting

  • University Clinical Center Kragujevac /ID# 266568

    Kragujevac, Sumadijski Okrug 34000
    Serbia

    Site Not Available

  • University Clinical Center Kragujevac /ID# 266568

    Kragujevac 789128, Sumadijski Okrug 34000
    Serbia

    Active - Recruiting

  • Institute for Oncology of Vojvodina /ID# 266556

    Sremska Kamenica, Vojvodina 21208
    Serbia

    Site Not Available

  • Institute for Oncology of Vojvodina /ID# 266556

    Kamenitz 3190104, Vojvodina 784272 21208
    Serbia

    Active - Recruiting

  • University Clinical Center Vojvodina /ID# 266674

    Novi Sad, 21000
    Serbia

    Site Not Available

  • University Clinical Center Vojvodina /ID# 266674

    Novi Sad 3194360, 21000
    Serbia

    Active - Recruiting

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

    Santiago de Compostela, A Coruna 15706
    Spain

    Site Not Available

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

    Santiago de Compostela 3109642, A Coruna 15706
    Spain

    Active - Recruiting

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

    Majadahonda, Madrid 28222
    Spain

    Site Not Available

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

    Majadahonda 3117667, Madrid 3117732 28222
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra - Pamplona /ID# 267762

    Pamplona, Navarra 31008
    Spain

    Site Not Available

  • Clinica Universidad de Navarra - Pamplona /ID# 267762

    Pamplona 3114472, Navarre 3115609 31008
    Spain

    Active - Recruiting

  • CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 266969

    Madrid, 28027
    Spain

    Site Not Available

  • Hospital MD Anderson Cancer Center Madrid /ID# 267167

    Madrid, 28033
    Spain

    Active - Recruiting

  • CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 266969

    Madrid 3117735, 28027
    Spain

    Active - Recruiting

  • Hospital MD Anderson Cancer Center Madrid /ID# 267167

    Madrid 3117735, 28033
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocio /ID# 266968

    Sevilla, 41013
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocio /ID# 266968

    Seville 2510911, 41013
    Spain

    Active - Recruiting

  • Kaohsiung Chang Gung Memorial Hospital /ID# 267046

    Kaohsiung City, Kaohsiung 833
    Taiwan

    Site Not Available

  • Kaohsiung Chang Gung Memorial Hospital /ID# 267046

    Kaohsiung City 1673820, Kaohsiung 7280289 833
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital /ID# 267017

    Taipei City, Taipei 7280290 100
    Taiwan

    Active - Recruiting

  • China Medical University Hospital /ID# 267018

    Taichung, 404
    Taiwan

    Site Not Available

  • China Medical University Hospital /ID# 267018

    Taichung 1668399, 404
    Taiwan

    Active - Recruiting

  • Linkou Chang Gung Memorial Hospital /ID# 267045

    Taoyuan 6696918, 333
    Taiwan

    Active - Recruiting

  • Linkou Chang Gung Memorial Hospital /ID# 267045

    Taoyuan City, 333
    Taiwan

    Site Not Available

  • Nottingham City Hospital /ID# 266991

    Nottingham, Nottinghamshire NG5 1PB
    United Kingdom

    Site Not Available

  • Nottingham City Hospital /ID# 266991

    Nottingham 2641170, Nottinghamshire NG5 1PB
    United Kingdom

    Active - Recruiting

  • Arizona Oncology - Tucson - Rudasill /ID# 267552

    Tucson, Arizona 85704
    United States

    Active - Recruiting

  • Southern VA Health Care System /ID# 266254

    Tucson, Arizona 85723
    United States

    Site Not Available

  • Arizona Oncology - Tucson - Rudasill /ID# 267552

    Tucson 5318313, Arizona 5551752 85704
    United States

    Active - Recruiting

  • Southern VA Health Care System /ID# 266254

    Tucson 5318313, Arizona 5551752 85723
    United States

    Active - Recruiting

  • UCSF FRESNO/Community Cancer Institute /ID# 270874

    Clovis, California 93611
    United States

    Site Not Available

  • Valkyrie Clinical Trials /ID# 268151

    Los Angeles, California 90067
    United States

    Site Not Available

  • UCSF FRESNO/Community Cancer Institute /ID# 270874

    Clovis 5338122, California 5332921 93611
    United States

    Active - Recruiting

  • Valkyrie Clinical Trials /ID# 268151

    Los Angeles 5368361, California 5332921 90067
    United States

    Active - Recruiting

  • Rocky Mountain Cancer Centers - Aurora /ID# 267549

    Aurora, Colorado 80012
    United States

    Site Not Available

  • Rocky Mountain Cancer Centers - Aurora /ID# 267549

    Aurora 5412347, Colorado 5417618 80012
    United States

    Active - Recruiting

  • Yale University School of Medicine /ID# 266224

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Yale University School of Medicine /ID# 266224

    New Haven 4839366, Connecticut 4831725 06510
    United States

    Active - Recruiting

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

    Gainesville, Florida 32608
    United States

    Site Not Available

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

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Mid Florida Hematology And Oncology Center /ID# 269159

    Orange City, Florida 32763
    United States

    Site Not Available

  • Comprehensive Hematology Oncology /ID# 267644

    Saint Petersburg, Florida 33709
    United States

    Site Not Available

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

    Gainesville 4156404, Florida 4155751 32608
    United States

    Active - Recruiting

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

    Jacksonville 4160021, Florida 4155751 32256
    United States

    Active - Recruiting

  • Mid Florida Hematology And Oncology Center /ID# 269159

    Orange City 4167055, Florida 4155751 32763
    United States

    Active - Recruiting

  • Comprehensive Hematology Oncology /ID# 267644

    St. Petersburg 4171563, Florida 4155751 33709
    United States

    Active - Recruiting

  • Springfield Clinic /ID# 270145

    Springfield, Illinois 62702-3749
    United States

    Site Not Available

  • Springfield Clinic - First /ID# 270145

    Springfield 4250542, Illinois 4896861 62702
    United States

    Active - Recruiting

  • Northwest Cancer Center - Dyer Clinic /ID# 268478

    Dyer, Indiana 46311
    United States

    Site Not Available

  • Northwest Cancer Center - Dyer Clinic /ID# 268478

    Dyer 4919820, Indiana 4921868 46311
    United States

    Active - Recruiting

  • Mission Cancer and Blood /ID# 267206

    Des Moines, Iowa 50309
    United States

    Active - Recruiting

  • University of Iowa Health Care /ID# 267206

    Des Moines, Iowa 50314-3017
    United States

    Site Not Available

  • University of Iowa Health Care /ID# 267206

    Des Moines 4853828, Iowa 4862182 50314-3017
    United States

    Active - Recruiting

  • Willis-Knighton Medical Center /ID# 270569

    Shreveport, Louisiana 71103
    United States

    Site Not Available

  • Willis-Knighton Medical Center /ID# 270569

    Shreveport 4341513, Louisiana 4331987 71103
    United States

    Active - Recruiting

  • American Oncology Partners of Maryland /ID# 266445

    Bethesda, Maryland 20817
    United States

    Active - Recruiting

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

    Bethesda, Maryland 20817
    United States

    Site Not Available

  • Maryland Oncology Hematology - Silver Spring /ID# 267557

    Silver Spring, Maryland 20904
    United States

    Site Not Available

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

    Bethesda 4348599, Maryland 4361885 20817
    United States

    Active - Recruiting

  • Maryland Oncology Hematology - Silver Spring /ID# 267557

    Silver Spring 4369596, Maryland 4361885 20904
    United States

    Active - Recruiting

  • UMass Memorial Medical Center /ID# 270023

    Worcester, Massachusetts 01605
    United States

    Site Not Available

  • UMass Memorial Medical Center /ID# 270023

    Worcester 4956184, Massachusetts 6254926 01605
    United States

    Active - Recruiting

  • Saint Luke's Hospital of Kansas City /ID# 267270

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Saint Luke's Hospital of Kansas City /ID# 267270

    Kansas City 4393217, Missouri 4398678 64111
    United States

    Active - Recruiting

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

    New York, New York 10029
    United States

    Site Not Available

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

    New York 5128581, New York 5128638 10029
    United States

    Active - Recruiting

  • Atrium Health /ID# 267219

    Charlotte, North Carolina 28204-2963
    United States

    Site Not Available

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

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Atrium Health /ID# 267219

    Charlotte 4460243, North Carolina 4482348 28204-2963
    United States

    Active - Recruiting

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

    Winston-Salem 4499612, North Carolina 4482348 27157
    United States

    Active - Recruiting

  • Cleveland Clinic Main Campus /ID# 271292

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Cleveland Clinic Main Campus /ID# 271292

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Active - Recruiting

  • Oklahoma Cancer Specialists and Research Institute /ID# 267643

    Tulsa, Oklahoma 74146
    United States

    Site Not Available

  • Oklahoma Cancer Specialists and Research Institute /ID# 267643

    Tulsa 4553433, Oklahoma 4544379 74146
    United States

    Active - Recruiting

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

    Eugene, Oregon 97401
    United States

    Site Not Available

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

    Eugene 5725846, Oregon 5744337 97401
    United States

    Active - Recruiting

  • Lifespan Cancer Institute - Providence /ID# 266550

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Lifespan Cancer Institute - Providence /ID# 266550

    Providence 5224151, Rhode Island 5224323 02903
    United States

    Active - Recruiting

  • Texas Oncology - Austin Midtown /ID# 268152

    Austin, Texas 78705
    United States

    Site Not Available

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

    Dallas, Texas 75235
    United States

    Site Not Available

  • Texas Oncology - Austin Midtown /ID# 268152

    Austin 4671654, Texas 4736286 78705
    United States

    Active - Recruiting

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

    Dallas 4684888, Texas 4736286 75235
    United States

    Active - Recruiting

  • Virginia Cancer Specialists - Gainesville /ID# 268155

    Gainesville, Virginia 20155-3257
    United States

    Active - Recruiting

  • Virginia Cancer Specialists - Gainesville /ID# 268155

    Gainesville 4760363, Virginia 6254928 20155-3257
    United States

    Active - Recruiting

  • Vista Oncology - East Olympia /ID# 267337

    Olympia, Washington 98506
    United States

    Site Not Available

  • Northwest Medical Specialties Tacoma /ID# 266327

    Tacoma, Washington 98405
    United States

    Site Not Available

  • Vista Oncology - East Olympia /ID# 267337

    Olympia 5805687, Washington 5815135 98506
    United States

    Active - Recruiting

  • Northwest Medical Specialties Tacoma /ID# 266327

    Tacoma 5812944, Washington 5815135 98405
    United States

    Active - Recruiting

  • West Virginia University School of Medicine /ID# 267645

    Morgantown, West Virginia 26506
    United States

    Site Not Available

  • West Virginia University School of Medicine /ID# 267645

    Morgantown 4815352, West Virginia 4826850 26506
    United States

    Active - Recruiting

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