Actively Recruiting
Acalabrutinib in Combination With Venetoclax or Obinutuzumab for the Treatment of Treatment-naive Chronic Lymphocytic Leukemia
Led by Ohio State University Comprehensive Cancer Center · Updated on 2026-02-19
52
Participants Needed
1
Research Sites
215 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II trial tests whether acalabrutinib in combination with venetoclax or obinutuzumab works to shrink tumors in patients with treatment-naive chronic lymphocytic leukemia . Acalabrutinib is also an inhibitor that works in the body to block the activation of certain cells that lead to the growth of cancerous B cells. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving acalabrutinib in combination with venetoclax or obinutuzumab may help ease symptoms, decrease the amount of cancer suggestive of improvement, prolonged disease-free remission and/or survival, and increased knowledge about cancer treatment in patients with chronic lymphocytic leukemia. Patients will be treated with acalabrutinib for 12 cycles, and then randomized to receive 6 cycles of acalabrutinib plus obinutuzumab or acalabrutinib plus venetoclax.
CONDITIONS
Official Title
Acalabrutinib in Combination With Venetoclax or Obinutuzumab for the Treatment of Treatment-naive Chronic Lymphocytic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women 18 years of age or older
- Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) according to 2018 guidelines
- No prior treatment for CLL except limited exceptions like palliative radiotherapy or specific therapies for autoimmune conditions
- Must meet treatment criteria including marrow failure, large or progressive spleen or lymph nodes, rapid lymphocyte increase, refractory autoimmune anemia or thrombocytopenia, symptomatic extranodal involvement, or constitutional symptoms
- ECOG performance status of 0 to 2
- Adequate bone marrow function unless cytopenias are due to disease involvement
- Absolute neutrophil count at least 1000/mm3
- Platelet count at least 30,000/mm3
- Hemoglobin at least 7 g/dL
- Total bilirubin no more than twice the upper limit of normal except Gilbert's syndrome
- AST and ALT no more than 2.5 times the upper limit of normal
- Creatinine clearance at least 30 mL/min/1.73m2
- Women of childbearing potential must use effective contraception during and after treatment
- Willing and able to participate in all study procedures and provide informed consent
You will not qualify if you...
- High-risk disease with deletion 17p13, TP53 mutation, or complex karyotype (3 or more abnormalities)
- Use of moderate or strong CYP3A inhibitors or inducers within 7 days before starting study drugs or need for these during the study
- Active involvement of central nervous system by lymphoma or leukemia
- Other malignancies with life expectancy less than 2 years or confounding toxicity assessment
- Significant cardiovascular disease including recent heart attack or severe heart failure, except controlled atrial fibrillation
- Inability to swallow oral medication or significant gastrointestinal disease affecting absorption
- Known HIV infection
- Active infections requiring intravenous antibiotics or antivirals
- Known hypersensitivity to study drugs or components
- Active bleeding disorders or uncontrolled autoimmune blood conditions unrelated to CLL
- Uncontrolled autoimmune diseases requiring high-dose steroids
- Recent gastrointestinal ulcers within 3 months
- Use of warfarin or vitamin K antagonists
- Abnormal clotting tests greater than twice normal
- Recent stroke or intracranial hemorrhage within 6 months
- Major surgery within 28 days before starting study drug without full recovery
- Positive hepatitis B surface antigen or PCR, or hepatitis C PCR positive
- Pregnant or breastfeeding
- Recent live vaccinations within 28 days
- Participation in another therapeutic clinical trial concurrently
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
T
The Ohio State University Comprehensive Cancer Center
CONTACT
M
Megan Nussbaum
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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