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: July 29, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

3

Condition

Chronic Lymphocytic Leukemia

Lymphoproliferative Disorders

Lymphocytic Leukemia, Chronic

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 immunethrombocytopenia.

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

    Active - Recruiting

  • Townsville University Hospital /ID# 266954

    Townsville, Queensland 4814
    Australia

    Active - Recruiting

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

    Fitzroy, Victoria 3065
    Australia

    Active - Recruiting

  • Royal Perth Hospital /ID# 266906

    Perth, Western Australia 6000
    Australia

    Active - Recruiting

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

    St-Priest-en-Jarez, Loire 42270
    France

    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

    Active - Recruiting

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

    Creteil, Paris 94010
    France

    Active - Recruiting

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

    Paris CEDEX 14, Paris 75679
    France

    Active - Recruiting

  • Centre Antoine-Lacassagne /ID# 266894

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

    Active - Recruiting

  • Centre Hospitalier de la Côte Basque /ID# 266847

    Bayonne, Pyrenees-Atlantiques 64109
    France

    Active - Recruiting

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

    Chambery CEDEX, Savoie 73007
    France

    Active - Recruiting

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

    Amiens CEDEX 1, Somme 80054
    France

    Active - Recruiting

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

    Argenteuil, 95107
    France

    Active - Recruiting

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

    Orléans, 45067
    France

    Active - Recruiting

  • Olympion General Clinic /ID# 266819

    Patras, Achaia 25443
    Greece

    Active - Recruiting

  • Evangelismos Hospital /ID# 266815

    Athens, Attiki 10676
    Greece

    Active - Recruiting

  • General Hospital of Athens Laiko /ID# 266813

    Athens, Attiki 11527
    Greece

    Active - Recruiting

  • University General Hospital Attikon /ID# 266814

    Athens, Attiki 12462
    Greece

    Active - Recruiting

  • University General Hospital of Alexandroupoli /ID# 266816

    Alexandroupoli, Evros 68100
    Greece

    Active - Recruiting

  • Pan American Center for Oncology Trials /ID# 266243

    Rio Piedras, 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

    Active - Recruiting

  • University Clinical Center Serbia /ID# 266579

    Belgrade, Beograd 11000
    Serbia

    Active - Recruiting

  • University Clinical Center Nis /ID# 266580

    Niš, Nisavski Okrug 18300
    Serbia

    Active - Recruiting

  • University Clinical Center Kragujevac /ID# 266568

    Kragujevac, Sumadijski Okrug 34000
    Serbia

    Active - Recruiting

  • Institute for Oncology of Vojvodina /ID# 266556

    Sremska Kamenica, Vojvodina 21208
    Serbia

    Active - Recruiting

  • University Clinical Center Vojvodina /ID# 266674

    Novi Sad, 21000
    Serbia

    Active - Recruiting

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

    Santiago de Compostela, A Coruna 15706
    Spain

    Active - Recruiting

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

    Majadahonda, Madrid 28222
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra - Pamplona /ID# 267762

    Pamplona, Navarra 31008
    Spain

    Active - Recruiting

  • CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 266969

    Madrid, 28027
    Spain

    Active - Recruiting

  • Hospital MD Anderson Cancer Center Madrid /ID# 267167

    Madrid, 28033
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocio /ID# 266968

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Kaohsiung Chang Gung Memorial Hospital /ID# 267046

    Kaohsiung City, Kaohsiung 833
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital /ID# 267017

    Taipei City, Taipei 100
    Taiwan

    Active - Recruiting

  • China Medical University Hospital /ID# 267018

    Taichung, 404
    Taiwan

    Active - Recruiting

  • Linkou Chang Gung Memorial Hospital /ID# 267045

    Taoyuan City, 333
    Taiwan

    Active - Recruiting

  • Nottingham City Hospital /ID# 266991

    Nottingham, 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

    Active - Recruiting

  • UCSF FRESNO/Community Cancer Institute /ID# 270874

    Clovis, California 93611
    United States

    Active - Recruiting

  • Valkyrie Clinical Trials /ID# 268151

    Los Angeles, California 90067
    United States

    Active - Recruiting

  • Rocky Mountain Cancer Centers - Aurora /ID# 267549

    Aurora, Colorado 80012
    United States

    Active - Recruiting

  • Yale University School of Medicine /ID# 266224

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

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

    Gainesville, Florida 32608
    United States

    Active - Recruiting

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

    Jacksonville, Florida 32256
    United States

    Active - Recruiting

  • Mid Florida Hematology And Oncology Center /ID# 269159

    Orange City, Florida 32763
    United States

    Active - Recruiting

  • Comprehensive Hematology Oncology /ID# 267644

    Saint Petersburg, Florida 33709
    United States

    Active - Recruiting

  • Springfield Clinic /ID# 270145

    Springfield, Illinois 62702-3749
    United States

    Active - Recruiting

  • Northwest Cancer Center - Dyer Clinic /ID# 268478

    Dyer, Indiana 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

    Active - Recruiting

  • Willis-Knighton Medical Center /ID# 270569

    Shreveport, Louisiana 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

    Active - Recruiting

  • Maryland Oncology Hematology - Silver Spring /ID# 267557

    Silver Spring, Maryland 20904
    United States

    Active - Recruiting

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

    Kansas City, Missouri 64111
    United States

    Active - Recruiting

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

    New York, New York 10029
    United States

    Active - Recruiting

  • Atrium Health /ID# 267219

    Charlotte, North Carolina 28204-2963
    United States

    Active - Recruiting

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

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

  • Cleveland Clinic Main Campus /ID# 271292

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Oklahoma Cancer Specialists and Research Institute /ID# 267643

    Tulsa, Oklahoma 74146
    United States

    Active - Recruiting

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

    Eugene, Oregon 97401
    United States

    Active - Recruiting

  • Lifespan Cancer Institute - Providence /ID# 266550

    Providence, Rhode Island 02903
    United States

    Active - Recruiting

  • Texas Oncology - Austin Midtown /ID# 268152

    Austin, Texas 78705
    United States

    Active - Recruiting

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

    Dallas, Texas 75235
    United States

    Active - Recruiting

  • Virginia Cancer Specialists - Gainesville /ID# 268155

    Gainesville, Virginia 20155-3257
    United States

    Active - Recruiting

  • Vista Oncology - East Olympia /ID# 267337

    Olympia, Washington 98506
    United States

    Active - Recruiting

  • Northwest Medical Specialties Tacoma /ID# 266327

    Tacoma, Washington 98405
    United States

    Active - Recruiting

  • West Virginia University School of Medicine /ID# 267645

    Morgantown, West Virginia 26506
    United States

    Active - Recruiting

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