Actively Recruiting
Acalabrutinib for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Led by Seema Bhat · Updated on 2025-12-16
61
Participants Needed
1
Research Sites
135 weeks
Total Duration
On this page
Sponsors
S
Seema Bhat
Lead Sponsor
A
Acerta Pharma, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial tests how well acalabrutinib works in treating patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and evaluates how treatment with acalabrutinib affects heart function. Acalabrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers at abnormal levels. This may help keep cancer cells from growing and spreading. CLL/SLL patients treated with a different BTK inhibitor called ibrutinib often experience cardiac side effects, leading to discontinuation of life-saving therapy. Treatment with acalabrutinib after discontinuing, or even before starting, treatment with ibrutinib may reverse or prevent cardiac side effects and be an effective treatment option for patients with CLL/SLL.
CONDITIONS
Official Title
Acalabrutinib for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women 18 years of age or older
- Diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma as defined by international criteria
- Cardiac intolerance to current ibrutinib treatment shown by atrial fibrillation or other cardiac arrhythmias
- Eastern Cooperative Oncology Group performance status 0 to 2
- Absolute neutrophil count of 1000/mm3 or higher (unless related to disease involvement)
- Platelet count of 30,000/mm3 or higher (unless related to disease involvement)
- Total bilirubin less than or equal to 1.5 times the upper limit of normal (except Gilbert's syndrome)
- AST and ALT less than or equal to 2.5 times the upper limit of normal
- Creatinine clearance of 30 mL/min/1.73m2 or higher
- Women of childbearing potential using effective contraception during treatment and for 2 days after last dose
- Willing and able to participate in all required evaluations and procedures
- Able to understand study purpose, risks, and provide informed consent
You will not qualify if you...
- Prior treatment with acalabrutinib (primary cohort) or any BTK inhibitor (pilot cohort)
- Presence of C481S or PLCG2 mutations
- Disease progression while on ibrutinib
- History of prior malignancies affecting study compliance or results except certain treated skin or cervical cancers and other cancers disease-free for 3 years
- Significant cardiovascular disease including prior myocarditis, congestive heart failure, heart attack, known infiltrative cardiomyopathy, or class 3 or 4 heart disease (controlled asymptomatic atrial fibrillation allowed)
- Prior allogeneic stem cell or cardiac transplantation
- Use of systemic or targeted anti-inflammatory medications like steroids
- Contraindications to MRI such as non-compatible metal implants, weight over 300 pounds, severe claustrophobia, advanced kidney disease, pregnancy, or cognitive impairments
- Difficulty swallowing oral medications or significant gastrointestinal disease
- Known HIV or active significant infections
- Allergy or anaphylaxis to study drugs or components
- Active bleeding disorders or history of bleeding diathesis
- Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura
- Recent gastrointestinal ulcer within 3 months
- Use of strong CYP3A4 inhibitors or inducers near study start
- Use of warfarin or equivalent anticoagulants
- Prothrombin time or activated partial thromboplastin time more than twice the upper limit of normal
- Use of proton pump inhibitors (switching to H2 blockers or antacids allowed)
- Recent significant cerebrovascular events within 6 months
- Major surgery within 28 days before study drug
- Recent live virus vaccination within 28 days
- History or ongoing progressive multifocal leukoencephalopathy
- Recent investigational drug use within 30 days or 5 half-lives
- Hepatitis B or C infection not meeting specific PCR-negative criteria
- Pregnant or breastfeeding
- Participation in another therapeutic clinical trial concurrently
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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