Actively Recruiting
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)
Led by AbbVie · Updated on 2026-04-09
170
Participants Needed
70
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. 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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of documented, previously untreated chronic lymphocytic leukemia (CLL) requiring treatment according to the 2018 iwCLL criteria and life expectancy greater than 6 months
- Previously untreated small lymphocytic lymphoma (SLL) meeting the 2018 iwCLL criteria for treatment considered as CLL
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Adequate bone marrow function within 2 weeks of screening, unless cytopenia is due to marrow involvement of CLL
- Creatinine clearance (CrCl) of 30 mL/min or higher calculated by the Cockcroft-Gault formula
You will not qualify if you...
- Active or uncontrolled infection
- Presence of Richter's transformation
- Active immune thrombocytopenia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 70 locations
1
Arizona Oncology - Tucson - Rudasill /ID# 267552
Tucson, Arizona, United States, 85704
Actively Recruiting
2
Southern VA Health Care System /ID# 266254
Tucson, Arizona, United States, 85723
Actively Recruiting
3
UCSF FRESNO/Community Cancer Institute /ID# 270874
Clovis, California, United States, 93611
Actively Recruiting
4
Valkyrie Clinical Trials /ID# 268151
Los Angeles, California, United States, 90067
Actively Recruiting
5
Rocky Mountain Cancer Centers - Aurora /ID# 267549
Aurora, Colorado, United States, 80012
Actively Recruiting
6
Yale University School of Medicine /ID# 266224
New Haven, Connecticut, United States, 06510
Actively Recruiting
7
Malcolm Randall V.A. Medical Center /ID# 267825
Gainesville, Florida, United States, 32608
Actively Recruiting
8
Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 266713
Jacksonville, Florida, United States, 32256
Actively Recruiting
9
Mid Florida Hematology And Oncology Center /ID# 269159
Orange City, Florida, United States, 32763
Actively Recruiting
10
Comprehensive Hematology Oncology /ID# 267644
St. Petersburg, Florida, United States, 33709
Actively Recruiting
11
Springfield Clinic - First /ID# 270145
Springfield, Illinois, United States, 62702
Actively Recruiting
12
Northwest Cancer Center - Dyer Clinic /ID# 268478
Dyer, Indiana, United States, 46311
Actively Recruiting
13
University of Iowa Health Care /ID# 267206
Des Moines, Iowa, United States, 50314-3017
Actively Recruiting
14
Willis-Knighton Medical Center /ID# 270569
Shreveport, Louisiana, United States, 71103
Completed
15
Center for Cancer and Blood Disorders-American Oncology Partners of Maryland /ID# 266445
Bethesda, Maryland, United States, 20817
Actively Recruiting
16
Maryland Oncology Hematology - Silver Spring /ID# 267557
Silver Spring, Maryland, United States, 20904
Actively Recruiting
17
UMass Memorial Medical Center /ID# 270023
Worcester, Massachusetts, United States, 01655
Actively Recruiting
18
Henry Ford Hospital /ID# 270973
Detroit, Michigan, United States, 48202
Actively Recruiting
19
Saint Lukes Hospital of Kansas City /ID# 267270
Kansas City, Missouri, United States, 64111
Actively Recruiting
20
Icahn School of Medicine at Mount Sinai /ID# 266328
New York, New York, United States, 10029
Actively Recruiting
21
Atrium Health /ID# 267219
Charlotte, North Carolina, United States, 28204-2963
Actively Recruiting
22
Atrium Health Wake Forest Baptist Medical Center /ID# 273142
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
23
Cleveland Clinic Main Campus /ID# 271292
Cleveland, Ohio, United States, 44195
Actively Recruiting
24
Oklahoma Cancer Specialists and Research Institute /ID# 267643
Tulsa, Oklahoma, United States, 74146
Actively Recruiting
25
Willamette Valley Cancer Institute and Research Center /ID# 266326
Eugene, Oregon, United States, 97401
Actively Recruiting
26
Lifespan Cancer Institute - Providence /ID# 266550
Providence, Rhode Island, United States, 02903
Actively Recruiting
27
Texas Oncology - Austin Midtown /ID# 268152
Austin, Texas, United States, 78705
Actively Recruiting
28
University of Texas - Southwestern Medical Center /ID# 266528
Dallas, Texas, United States, 75235
Actively Recruiting
29
Virginia Cancer Specialists - Fairfax /ID# 268155
Fairfax, Virginia, United States, 22031
Actively Recruiting
30
Vista Oncology - East Olympia /ID# 267337
Olympia, Washington, United States, 98506
Actively Recruiting
31
Northwest Medical Specialties Tacoma /ID# 266327
Tacoma, Washington, United States, 98405
Actively Recruiting
32
West Virginia University School of Medicine /ID# 267645
Morgantown, West Virginia, United States, 26506
Actively Recruiting
33
Calvary Mater Newcastle /ID# 267408
Waratah, New South Wales, Australia, 2298
Actively Recruiting
34
Townsville University Hospital /ID# 266954
Townsville, Queensland, Australia, 4814
Actively Recruiting
35
St Vincent's Hospital - Melbourne /ID# 270027
Fitzroy, Victoria, Australia, 3065
Actively Recruiting
36
Royal Perth Hospital /ID# 266906
Perth, Western Australia, Australia, 6000
Actively Recruiting
37
Centre Hospitalier Régional Metz Thionville - Hôpital de Mercy /ID# 266852
Metz, Moselle, France, 57085
Actively Recruiting
38
Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 266270
Créteil, Paris, France, 94010
Actively Recruiting
39
Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 267438
Paris, Paris, France, 75679
Actively Recruiting
40
Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 266319
St-Priest-en-Jarez, Pays de la Loire Region, France, 42270
Actively Recruiting
41
Centre Antoine-Lacassagne /ID# 266894
Nice, Provence-Alpes-Côte d'Azur Region, France, 06189
Actively Recruiting
42
Centre Hospitalier de la Côte Basque /ID# 266847
Bayonne, Pyrenees-Atlantiques, France, 64109
Actively Recruiting
43
Centre Hospitalier Métropole Savoie - Site Hôpital de Chambéry /ID# 266854
Chambéry, Savoie, France, 73007
Actively Recruiting
44
CHU Amiens-Picardie Site Sud /ID# 266849
Amiens, Somme, France, 80054
Actively Recruiting
45
Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 266272
Orléans, France, 45067
Actively Recruiting
46
Centre Hospitalier d Argenteuil Victor Dupouy /ID# 266322
Argenteuil, Île-de-France Region, France, 95107
Actively Recruiting
47
Olympion General Clinic /ID# 266819
Pátrai, Achaia, Greece, 26443
Actively Recruiting
48
Evangelismos Hospital /ID# 266815
Athens, Attica, Greece, 10676
Actively Recruiting
49
General Hospital of Athens Laiko /ID# 266813
Athens, Attica, Greece, 11527
Actively Recruiting
50
University General Hospital Attikon /ID# 266814
Athens, Attica, Greece, 12462
Actively Recruiting
51
University General Hospital of Alexandroupoli /ID# 266816
Alexandroupoli, Evros, Greece, 68100
Actively Recruiting
52
Pan American Center for Oncology Trials /ID# 266243
Rio Piedras, Puerto Rico, 00935
Actively Recruiting
53
Clinical Hospital Center Zvezdara /ID# 266560
Belgrade, Beograd, Serbia, 11000
Actively Recruiting
54
University Clinical Center Serbia /ID# 266579
Belgrade, Beograd, Serbia, 11000
Actively Recruiting
55
Clinical Hospital Center - Bežanijska Kosa /ID# 266567
Belgrade, Beograd, Serbia, 11080
Actively Recruiting
56
University Clinical Center Nis /ID# 266580
Niš, Nisavski Okrug, Serbia, 18300
Actively Recruiting
57
University Clinical Center Kragujevac /ID# 266568
Kragujevac, Sumadijski Okrug, Serbia, 34000
Actively Recruiting
58
Institute for Oncology of Vojvodina /ID# 266556
Kamenitz, Vojvodina, Serbia, 21208
Actively Recruiting
59
University Clinical Center Vojvodina /ID# 266674
Novi Sad, Serbia, 21000
Actively Recruiting
60
Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 267164
Santiago de Compostela, A Coruna, Spain, 15706
Actively Recruiting
61
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 266967
Majadahonda, Madrid, Spain, 28222
Actively Recruiting
62
Clinica Universidad de Navarra - Pamplona /ID# 267762
Pamplona, Navarre, Spain, 31008
Actively Recruiting
63
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 266969
Madrid, Spain, 28027
Actively Recruiting
64
Hospital MD Anderson Cancer Center Madrid /ID# 267167
Madrid, Spain, 28033
Actively Recruiting
65
Hospital Universitario Virgen del Rocio /ID# 266968
Seville, Spain, 41013
Actively Recruiting
66
Kaohsiung Chang Gung Memorial Hospital /ID# 267046
Kaohsiung City, Kaohsiung, Taiwan, 833
Actively Recruiting
67
China Medical University Hospital /ID# 267018
Taichung, Taiwan, 40447
Actively Recruiting
68
National Taiwan University Hospital /ID# 267017
Taipei, Taiwan, 100
Actively Recruiting
69
Linkou Chang Gung Memorial Hospital /ID# 267045
Taoyuan City, Taiwan, 333
Actively Recruiting
70
Nottingham City Hospital /ID# 266991
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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