Actively Recruiting
Prospective Phase 2 Study of the Effect of Acalabrutinib on Heart Muscle in Ibrutinib-Exposed Patients With Chronic Lymphocytic Leukemia
Led by Seema Bhat · Updated on 2025-12-16
61
Participants Needed
1
Research Sites
52 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
Researchers are evaluating how well acalabrutinib works in treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and how it affects heart function. This phase II study focuses on patients who have experienced heart-related side effects from a similar drug called ibrutinib, aiming to see if acalabrutinib can prevent or reverse these cardiac issues while controlling the disease. Patients receive acalabrutinib by mouth twice daily in 28-day cycles, continuing as long as the disease does not progress or side effects are unacceptable. Throughout the study, participants undergo cardiac magnetic resonance imaging (CMR), computed tomography (CT), bone marrow aspiration and biopsy, and blood sample collection. After the treatment period ends, patients are followed every six months for up to ten years to monitor long-term effects. Participants will have regular assessments including imaging scans, blood tests, and bone marrow procedures to evaluate heart changes, disease response, mutation status, and adverse events. The main measure is the change in cardiac MRI from baseline to three months after starting acalabrutinib, with additional monitoring of response rates, progression-free survival, atrial fibrillation rates, and biomarker levels. Safety and disease progression will be tracked throughout the study and follow-up period.
CONDITIONS
Brief 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 aged 18 years or older
- Diagnosed with chronic lymphocytic leukemia or small lymphocytic lymphoma as defined by standard criteria
- Experienced cardiac intolerance to ibrutinib, such as atrial fibrillation or other heart rhythm problems
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Absolute neutrophil count (ANC) of 1000/mm^3 or higher unless due to bone marrow involvement or disease-related immune thrombocytopenia
- Platelet count of 30,000/mm^3 or higher unless due to bone marrow involvement or disease-related immune thrombocytopenia
- Total bilirubin less than or equal to 1.5 times the upper limit of normal except for Gilbert's syndrome
- Liver enzymes (AST and ALT) less than or equal to 2.5 times the upper limit of normal
- Creatinine clearance of 30 mL/min/1.73m^2 or higher
- Women of childbearing potential must use effective contraception during treatment and for 2 days after last dose
- Willing and able to complete all study evaluations and procedures
- Able to understand study purpose, risks, and provide informed consent
You will not qualify if you...
- Previous treatment with acalabrutinib or other BTK inhibitors
- Presence of C481S or PLCG2 genetic mutations
- Disease progression while on ibrutinib
- History of other cancers that may affect study results except certain treated skin or cervical cancers or other cancers treated and disease-free for 3 years
- Significant heart diseases like prior myocarditis, heart failure, heart attack, or infiltrative cardiomyopathies except controlled asymptomatic atrial fibrillation
- Prior stem cell or heart transplants
- Use of systemic or non-cancer targeted anti-inflammatory medications like steroids
- Contraindications to MRI such as incompatible implants, weight over 300 pounds, severe claustrophobia, advanced kidney disease, pregnancy, or cognitive disability
- Difficulty swallowing oral medication or gastrointestinal diseases affecting absorption
- Active infections including HIV or significant bacterial, viral, or fungal infections
- Allergy or hypersensitivity to study drugs or components
- Active bleeding disorders or uncontrolled autoimmune blood conditions
- Recent gastrointestinal ulcers
- Use of strong CYP3A4 inhibitors or inducers within specific timeframes before study
- Use of warfarin or similar anticoagulants
- Blood clotting abnormalities beyond specified limits
- Use of proton pump inhibitors unless switching to alternatives
- Recent significant stroke or brain hemorrhage
- Major surgery within 28 days before study drug
- Recent live virus vaccinations
- Progressive multifocal leukoencephalopathy
- Recent use of other investigational drugs
- Positive hepatitis B or C tests unless controlled
- Pregnant or breastfeeding
- Participation in another therapeutic clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 cycles of 28 days each
Participants receive acalabrutinib orally twice daily on days 1-28 of each 28-day cycle. Treatment continues in the absence of disease progression or unacceptable side effects. Participants also undergo cardiac MRI, CT scans, bone marrow aspiration and biopsy, and blood sample collection throughout this period.
Monthly visits for up to 24 months
Duration - Up to 10 years
After completing treatment, participants are followed up every 6 months for up to 10 years to monitor long-term outcomes and safety.
Visits every 6 months
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
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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