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)
NCT ID: NCT06428019
Last Updated: 2025-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
170 participants
INTERVENTIONAL
2024-08-05
2028-03-31
Brief Summary
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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.
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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Venetoclax + Obinutuzumab
Participants will receive venetoclax in combination with obinutuzumab, with a 5 week venetoclax ramp up.
Venetoclax
Oral: Tablet
Obinutuzumab
Intravenous Infusion
Arm B: Venetoclax + Acalabrutinib
Participants will receive venetoclax in combination with acalabrutinib, with a 5 week venetoclax ramp up.
Venetoclax
Oral: Tablet
Acalabrutinib
Oral: Tablet
Arm C: Venetoclax + Acalabrutinib
Participants will receive venetoclax in combination with acalabrutinib, with a modified venetoclax ramp up A.
Venetoclax
Oral: Tablet
Acalabrutinib
Oral: Tablet
Arm D: Venetoclax + Acalabrutinib
Participants will receive venetoclax in combination with acalabrutinib, with a modified venetoclax ramp up B.
Venetoclax
Oral: Tablet
Acalabrutinib
Oral: Tablet
Interventions
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Venetoclax
Oral: Tablet
Acalabrutinib
Oral: Tablet
Obinutuzumab
Intravenous Infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Arizona Oncology - Tucson - Rudasill /ID# 267552
Tucson, Arizona, United States
Southern VA Health Care System /ID# 266254
Tucson, Arizona, United States
UCSF FRESNO/Community Cancer Institute /ID# 270874
Clovis, California, United States
Valkyrie Clinical Trials /ID# 268151
Los Angeles, California, United States
Rocky Mountain Cancer Centers - Aurora /ID# 267549
Aurora, Colorado, United States
Yale University School of Medicine /ID# 266224
New Haven, Connecticut, United States
Malcolm Randall V.A. Medical Center /ID# 267825
Gainesville, Florida, United States
Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 266713
Jacksonville, Florida, United States
Mid Florida Hematology And Oncology Center /ID# 269159
Orange City, Florida, United States
Comprehensive Hematology Oncology /ID# 267644
St. Petersburg, Florida, United States
Springfield Clinic - First /ID# 270145
Springfield, Illinois, United States
Northwest Cancer Center - Dyer Clinic /ID# 268478
Dyer, Indiana, United States
University of Iowa Health Care /ID# 267206
Des Moines, Iowa, United States
Willis-Knighton Medical Center /ID# 270569
Shreveport, Louisiana, United States
Center for Cancer and Blood Disorders-American Oncology Partners of Maryland /ID# 266445
Bethesda, Maryland, United States
Maryland Oncology Hematology - Silver Spring /ID# 267557
Silver Spring, Maryland, United States
UMass Memorial Medical Center /ID# 270023
Worcester, Massachusetts, United States
Henry Ford Hospital /ID# 270973
Detroit, Michigan, United States
Saint Lukes Hospital of Kansas City /ID# 267270
Kansas City, Missouri, United States
Icahn School of Medicine at Mount Sinai /ID# 266328
New York, New York, United States
Atrium Health /ID# 267219
Charlotte, North Carolina, United States
Atrium Health Wake Forest Baptist Medical Center /ID# 273142
Winston-Salem, North Carolina, United States
Cleveland Clinic Main Campus /ID# 271292
Cleveland, Ohio, United States
Oklahoma Cancer Specialists and Research Institute /ID# 267643
Tulsa, Oklahoma, United States
Willamette Valley Cancer Institute and Research Center /ID# 266326
Eugene, Oregon, United States
Lifespan Cancer Institute - Providence /ID# 266550
Providence, Rhode Island, United States
Texas Oncology - Austin Midtown /ID# 268152
Austin, Texas, United States
University of Texas - Southwestern Medical Center /ID# 266528
Dallas, Texas, United States
Virginia Cancer Specialists - Gainesville /ID# 268155
Gainesville, Virginia, United States
Vista Oncology - East Olympia /ID# 267337
Olympia, Washington, United States
Northwest Medical Specialties Tacoma /ID# 266327
Tacoma, Washington, United States
West Virginia University School of Medicine /ID# 267645
Morgantown, West Virginia, United States
Calvary Mater Newcastle /ID# 267408
Waratah, New South Wales, Australia
Townsville University Hospital /ID# 266954
Townsville, Queensland, Australia
St Vincent's Hospital - Melbourne /ID# 270027
Fitzroy, Victoria, Australia
Royal Perth Hospital /ID# 266906
Perth, Western Australia, Australia
Centre Hospitalier Régional Metz Thionville - Hôpital de Mercy /ID# 266852
Metz, Moselle, France
Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 266270
Créteil, Paris, France
Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 267438
Paris, Paris, France
Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 266319
St-Priest-en-Jarez, Pays de la Loire Region, France
Centre Antoine-Lacassagne /ID# 266894
Nice, Provence-Alpes-Côte d'Azur Region, France
Centre Hospitalier de la Côte Basque /ID# 266847
Bayonne, Pyrenees-Atlantiques, France
Centre Hospitalier Métropole Savoie - Site Hôpital de Chambéry /ID# 266854
Chambéry, Savoie, France
CHU Amiens-Picardie Site Sud /ID# 266849
Amiens, Somme, France
Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 266272
Orléans, , France
Centre Hospitalier d Argenteuil Victor Dupouy /ID# 266322
Argenteuil, Île-de-France Region, France
Olympion General Clinic /ID# 266819
Pátrai, Achaia, Greece
Evangelismos Hospital /ID# 266815
Athens, Attica, Greece
General Hospital of Athens Laiko /ID# 266813
Athens, Attica, Greece
University General Hospital Attikon /ID# 266814
Athens, Attica, Greece
University General Hospital of Alexandroupoli /ID# 266816
Alexandroupoli, Evros, Greece
Pan American Center for Oncology Trials /ID# 266243
Rio Piedras, , Puerto Rico
Clinical Hospital Center Zvezdara /ID# 266560
Belgrade, Beograd, Serbia
University Clinical Center Serbia /ID# 266579
Belgrade, Beograd, Serbia
Clinical Hospital Center - Bežanijska Kosa /ID# 266567
Belgrade, Beograd, Serbia
University Clinical Center Nis /ID# 266580
Niš, Nisavski Okrug, Serbia
University Clinical Center Kragujevac /ID# 266568
Kragujevac, Sumadijski Okrug, Serbia
Institute for Oncology of Vojvodina /ID# 266556
Kamenitz, Vojvodina, Serbia
University Clinical Center Vojvodina /ID# 266674
Novi Sad, , Serbia
Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 267164
Santiago de Compostela, A Coruna, Spain
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 266967
Majadahonda, Madrid, Spain
Clinica Universidad de Navarra - Pamplona /ID# 267762
Pamplona, Navarre, Spain
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 266969
Madrid, , Spain
Hospital MD Anderson Cancer Center Madrid /ID# 267167
Madrid, , Spain
Hospital Universitario Virgen del Rocio /ID# 266968
Seville, , Spain
Kaohsiung Chang Gung Memorial Hospital /ID# 267046
Kaohsiung City, Kaohsiung, Taiwan
National Taiwan University Hospital /ID# 267017
Taipei City, Taipei, Taiwan
China Medical University Hospital /ID# 267018
Taichung, , Taiwan
Linkou Chang Gung Memorial Hospital /ID# 267045
Taoyuan, , Taiwan
Nottingham City Hospital /ID# 266991
Nottingham, Nottinghamshire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Site Coordinator
Role: primary
Related Links
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Other Identifiers
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2024-512147-23-00
Identifier Type: OTHER
Identifier Source: secondary_id
M24-287
Identifier Type: -
Identifier Source: org_study_id
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