Acalabrutinib with Venetoclax or Obinutuzumab for Untreated CLL
This study is for people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have not yet received treatment. It is testing if combining acalabrutinib with either venetoclax or obinutuzumab can shrink tumors. Acalabrutinib works by blocking certain cells that help cancer grow. Venetoclax stops cancer cells by blocking a protein they need to survive, and obinutuzumab is an antibody that may prevent cancer cells from growing and spreading. The main goal is to see how many people achieve undetectable minimal residual disease (uMRD) in their bone marrow after treatment. This means very few cancer cells are found. The study plans to enroll 52 participants, but its current status is unclear.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It aims to enroll 52 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint is measured up to 1 year after treatment completion.
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NCT05336812
Acalabrutinib in Combination With Venetoclax or Obinutuzumab for the Treatment of Treatment-naive Chronic Lymphocytic Leukemia
Recruiting
PHASE2Ages 18+InterventionalTreatmentOhio State University Comprehensive Cancer CenterInvestigator-initiated
~52 participants
Updated 2026-02-19 on ClinicalTrials.gov
What's tested:AcalabrutinibObinutuzumabVenetoclax
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of bone marrow undetectable minimal residual disease (uMRD), defined as tumor cell in 10,000 cells using standard flow based assay, achieved after completion of therapy
Measured over Up to 1 year
Conditions
Where it's being run
1 sites across 1 statesOhio1
Study leadership
- Kerry S Rogers, MD · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Men and women \>= 18 years of age
Diagnosis of CLL/small lymphocytic lymphoma (SLL) meeting criteria established in the 2018 International Workshop (iw)CLL guidelines
Must be treatment-naive: Received no prior chemotherapy, immunotherapy, or targeted therapy for the treatment of CLL, with the exceptions of palliative loco-regional radiotherapy, rituximab for autoimmune conditions, or corticosteroids for symptoms control
Patients must meet criteria for treatment as defined by 2018 iwCLL guidelines which includes at least one of the following criteria:
Evidence of marrow failure as manifested by the development or worsening of anemia or thrombocytopenia (not attributable to autoimmune hemolytic anemia or thrombocytopenia)
Massive (\>= 6 cm below the costal margin), progressive or symptomatic splenomegaly
Massive nodes (\>= 10 cm) or progressive or symptomatic lymphadenopathy
Progressive lymphocytosis with a lymphocyte doubling time \< 6 months or an increase of \>= 50% over a 2 month period
Autoimmune anemia and/or thrombocytopenia that is poorly responsive to standard therapy
Symptomatic or functional extranodal involvement (e.g. skin, kidney, lung, spine)
Constitutional symptoms, which include any of the following:
Unintentional weight loss of 10% or more within 6 months
Significant fatigue
Fevers \> 100.5 degrees Fahrenheit (F) for 2 weeks or more without evidence of infection
Night sweats \>= 1 month without evidence of infection
Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
Adequate bone marrow independent of growth factor support or infusion support at screening unless evidence shows that the cytopenia(s) is due to marrow involvement by CLL/SLL and/or disease-related immune thrombocytopenia, or anemia. If cytopenias are due to disease in the bone marrow any degree of cytopenias are allowed. Patients with active uncontrolled autoimmune cytopenias are excluded
Absolute neutrophil count (ANC) \>= 1000/mm\^3
Platelets \>= 30,000/mm\^3
Hemoglobin \>= 7 g/dL
Total bilirubin =\< 2.0 x upper limit of normal (ULN) (excepting Gilbert's syndrome)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x ULN
Creatinine clearance \>= 30 mL/min/1.73m\^2
Using 24-hour creatinine clearance or modified Cockcroft-Gault equation
Woman of childbearing potential (WOCBP) who are sexually active must use highly effective methods of contraception during treatment and for at least 2 days after last acalabrutinib dose, 30 days after last venetoclax dose, and 6 months after last obinutuzumab dose
Willing and able to participate in all required evaluations and procedures in this study protocol
Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information
Exclusion
Patients with high-risk disease as defined by:
Presence of deletion 17p13 on cytogenetic analysis by fluorescent in situ hybridization (FISH)
Presence of TP53 mutation on next generation sequencing
Presence of complex karyotype on cytogenetic evaluation
Defined as \>= 3 karyotypic abnormalities
Treatment with a moderate or strong CYP3A inhibitor or inducer within 7 days prior to first dose of acalabrutinib or venetoclax or need for treatment with a strong CYP3A inhibitor or inducer during the period or the study. Patients who have a need for treatment with a moderate CYP3A inhibitor or inducer during acalabrutinib or venetoclax dose escalation will also be excluded
Known active involvement of the central nervous system by lymphoma or leukemia
Subject with other malignancies that are associated with a life expectancy of \< 2 years or that would confound assessment of toxicity in this study
Clinically significant cardiovascular disease such as symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification. Note: Subjects with controlled atrial fibrillation can enroll on study
Is unable to swallow oral medication, or has significant gastrointestinal disease that would limit absorption of oral medication
Known history of infection with human immunodeficiency virus (HIV)
Subjects with active infections requiring intravenous (IV) antibiotic/antiviral therapy are not eligible for entry onto the study until resolution of the infection. Subjects on prophylactic antibiotics or antivirals are acceptable
Known history of hypersensitivity or anaphylaxis to study drug(s) including active product or excipient components
Active bleeding or history of bleeding diathesis (e.g., hemophilia or von Willebrand disease)
Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP) unrelated to underlying CLL
Patients with uncontrolled autoimmune disease requiring \> 20 mg of daily prednisone or equivalent
Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening
Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists
Prothrombin time (PT)/international normalized ratio (INR) or activated partial thromboplastin time (aPTT) (in the absence of lupus anticoagulant) \> 2 x ULN
History of significant cerebrovascular disease/event, including stroke or intracranial hemorrhage, within 6 months before the first dose of study drug
Major surgical procedure within 28 days of first dose of study drug. Note: If a subject had major surgery, they must have recovered adequately from any toxicity and/or complications from the intervention before the first dose of study drug
Hepatitis B or C serologic status:
Subjects who are hepatitis B core antibody (anti-HBc) positive and who are hepatitis B surface antigen (HBsAg) negative will need to have a negative polymerase chain reaction (PCR) and must be willing to undergo deoxyribonucleic acid (DNA) PCR testing during the study to be eligible. Those who are HBsAg positive or hepatitis B PCR positive will be excluded
Subjects who are hepatitis C antibody positive will need to have a negative PCR result to be eligible. Those who are hepatitis C PCR positive will be excluded
Breastfeeding or pregnant
Vaccination with live vaccines 28 days prior to registration for study screening
Concurrent participation in another therapeutic clinical trial
What this trial measures
- Rate of bone marrow undetectable minimal residual disease (uMRD), defined as tumor cell in 10,000 cells using standard flow based assay, achieved after completion of therapyUp to 1 year
Will provide uMRD rates at the end of treatment with combination therapy for each experimental arm with 95% confidence intervals.