Recruiting

Phase 3

Venetoclax & ObinutuzumabA 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)

Sponsor:

AbbVie

Code:

NCT06428019

Conditions

Chronic Lymphocytic Leukemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Venetoclax

Acalabrutinib

Obinutuzumab

Study Details

Brief 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 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

Chronic Lymphocytic Leukemia

Study ID

NCT06428019

Start date

Aug 5, 2024

Status verified date

Apr, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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.

Exclusion Criteria:

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

Study Design

Enrollment

170 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A: Venetoclax + Obinutuzumab

Participants will receive venetoclax in combination with obinutuzumab, with a 5 week venetoclax ramp up.

experimental: Arm B: Venetoclax + Acalabrutinib

Participants will receive venetoclax in combination with acalabrutinib, with a 5 week venetoclax ramp up.

experimental: Arm C: Venetoclax + Acalabrutinib

Participants will receive venetoclax in combination with acalabrutinib, with a modified venetoclax ramp up A.

experimental: Arm D: Venetoclax + Acalabrutinib

Participants will receive venetoclax in combination with acalabrutinib, with a modified venetoclax ramp up B.

Interventions

Venetoclax

Oral: Tablet

Acalabrutinib

Oral: Tablet

Obinutuzumab

Intravenous Infusion

Primary outcome measure

Part 1: Percentage of Participants with Treatment-Emergent Laboratory Tumor Lysis Syndrome (TLS)-Venetoclax [ Time Frame: Up to 28 Months ]
Part 1: Percentage of Participants with Hyperkalemia-Venetoclax [ Time Frame: Up to 28 Months ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742 abbvieclinicaltrials@abbvie.com

Locations

Arizona Oncology - Tucson - Rudasill /ID# 267552

Recruiting

Tucson, Arizona, United States, 85704

Southern VA Health Care System /ID# 266254

Recruiting

Tucson, Arizona, United States, 85723

UCSF FRESNO/Community Cancer Institute /ID# 270874

Recruiting

Clovis, California, United States, 93611

Valkyrie Clinical Trials /ID# 268151

Recruiting

Los Angeles, California, United States, 90067

Rocky Mountain Cancer Centers - Aurora /ID# 267549

Recruiting

Aurora, Colorado, United States, 80012

Yale University School of Medicine /ID# 266224

Recruiting

New Haven, Connecticut, United States, 06510

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

Recruiting

Gainesville, Florida, United States, 32608

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

Recruiting

Jacksonville, Florida, United States, 32256

Mid Florida Hematology And Oncology Center /ID# 269159

Recruiting

Orange City, Florida, United States, 32763

Comprehensive Hematology Oncology /ID# 267644

Recruiting

St. Petersburg, Florida, United States, 33709

Springfield Clinic - First /ID# 270145

Recruiting

Springfield, Illinois, United States, 62702

Northwest Cancer Center - Dyer Clinic /ID# 268478

Recruiting

Dyer, Indiana, United States, 46311

University of Iowa Health Care /ID# 267206

Recruiting

Des Moines, Iowa, United States, 50314-3017

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

Recruiting

Bethesda, Maryland, United States, 20817

Maryland Oncology Hematology - Silver Spring /ID# 267557

Recruiting

Silver Spring, Maryland, United States, 20904

UMass Memorial Medical Center /ID# 270023

Recruiting

Worcester, Massachusetts, United States, 01655

Henry Ford Hospital /ID# 270973

Recruiting

Detroit, Michigan, United States, 48202

Saint Lukes Hospital of Kansas City /ID# 267270

Recruiting

Kansas City, Missouri, United States, 64111

Icahn School of Medicine at Mount Sinai /ID# 266328

Recruiting

New York, New York, United States, 10029

Atrium Health /ID# 267219

Recruiting

Charlotte, North Carolina, United States, 28204-2963

Atrium Health Wake Forest Baptist Medical Center /ID# 273142

Recruiting

Winston-Salem, North Carolina, United States, 27157

Cleveland Clinic Main Campus /ID# 271292

Recruiting

Cleveland, Ohio, United States, 44195

Oklahoma Cancer Specialists and Research Institute /ID# 267643

Recruiting

Tulsa, Oklahoma, United States, 74146

Willamette Valley Cancer Institute and Research Center /ID# 266326

Recruiting

Eugene, Oregon, United States, 97401

Lifespan Cancer Institute - Providence /ID# 266550

Recruiting

Providence, Rhode Island, United States, 02903

Texas Oncology - Austin Midtown /ID# 268152

Recruiting

Austin, Texas, United States, 78705

University of Texas - Southwestern Medical Center /ID# 266528

Recruiting

Dallas, Texas, United States, 75235

Virginia Cancer Specialists - Fairfax /ID# 268155

Recruiting

Fairfax, Virginia, United States, 22031

Vista Oncology - East Olympia /ID# 267337

Recruiting

Olympia, Washington, United States, 98506

Contacts

Site Coordinator

360-413-8880 opt 4

Northwest Medical Specialties Tacoma /ID# 266327

Recruiting

Tacoma, Washington, United States, 98405

West Virginia University School of Medicine /ID# 267645

Recruiting

Morgantown, West Virginia, United States, 26506

More Information

Sponsor

AbbVie

Last update posted

Apr 9, 2026

Last verified

Apr, 2026

Keywords

Chronic Lymphocytic Leukemia
CLL
Venetoclax
ABT-199
Obinutuzumab
Acalabrutinib

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AbbVie on 2026-04-09.