Acalabrutinib for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
This study is testing a medication called acalabrutinib for people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Acalabrutinib is a kinase inhibitor, meaning it blocks a protein called BTK that helps cancer cells grow. This trial is for patients who have had heart-related side effects from a different BTK inhibitor called ibrutinib. Researchers want to see how acalabrutinib affects heart function and if it can effectively treat CLL/SLL in these patients. The study will measure changes in your heart using MRI scans. The study is currently unclear on its recruitment status and plans to enroll 61 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 61 participants.
- What's involved
- You would take acalabrutinib by mouth. You would also have blood samples collected, bone marrow aspirations and biopsies, and CT scans. Heart MRI changes will be measured from the start of treatment to 3 months later.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will assess atrial fibrillation rates at 12 months after switching to acalabrutinib. It will also determine progression-free survival at 3 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06757647
Acalabrutinib for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Recruiting
PHASE2Ages 18+InterventionalTreatmentSeema BhatInvestigator-initiated
~61 participants
Updated 2025-12-16 on ClinicalTrials.gov
What's tested:AcalabrutinibBiospecimen CollectionBone Marrow AspirationBone Marrow BiopsyComputed TomographyMagnetic Resonance Imaging of the Heart
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cardiac magnetic resonance imaging changes
Measured over Baseline to 3-month post acalabrutinib initiation
Conditions
Where it's being run
1 sites across 1 statesOhio1
Study leadership
- Seema A Bhat, MD · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Men and women \>= 18 years of age
Diagnosis of CLL/SLL meeting criteria as defined by International Workshop on Chronic Lymphocytic Leukemia (iWCLL) 2018 criteria
CLL patients cardiac intolerant to current treatment with ibrutinib as defined by AF or other cardiac arrhythmias. Other ibrutinib-related intolerances will be excluded
Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
Absolute neutrophil count (ANC) \>= 1000/mm\^3 (Independent of growth factor support at screening unless due to marrow involvement by CLL/SLL and/or disease-related immune thrombocytopenia. If cytopenias are due to disease in the bone marrow any degree of cytopenias is allowed. Patients with active uncontrolled autoimmune cytopenias are excluded)
Platelets \>= 30,000/mm\^3 (Independent of growth factor support at screening unless due to marrow involvement by CLL/SLL and/or disease-related immune thrombocytopenia. If cytopenias are due to disease in the bone marrow any degree of cytopenias is allowed. Patients with active uncontrolled autoimmune cytopenias are excluded)
Total bilirubin =\< 1.5 x upper limit of normal (ULN) (excepting Gilbert's syndrome) (at screening)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x ULN (at screening)
Creatinine clearance \>= 30 mL/min/1.73m\^2 (at screening)
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 2 days after the last dose of acalabrutinib
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
Prior exposure to acalabrutinib for primary cohort and prior exposure to BTK inhibitor for pilot cohort
Presence of C481S mutation or PCLG2 mutation
Disease progression on ibrutinib
History of prior malignancy that could affect compliance with the protocol or interpretation of results, except for the following:
Curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or carcinoma in situ of the prostate at any time prior to study
Other cancers not specified above that have been curatively treated by surgery and/or radiation therapy from which subject is disease-free for \>= 3 years without further treatment
Clinically significant cardiovascular disease such as prior myocarditis, congestive heart failure, prior documented myocardial infarction (i.e., not self-reported), known infiltrative cardiomyopathy (ex. cardiac sarcoidosis, cardiac amyloidosis, etc.) or any class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification. Note: Subjects with controlled, asymptomatic atrial fibrillation can enroll on study
Prior allogeneic stem cell transplantation
Prior cardiac transplantation
Systemic or non-cancer targeted anti-inflammatory medications (i.e., steroids)
Contradictions to MRI: non-compatible metal implant, weight \> 300 pounds (lbs.) (MRI scanner limit), severe claustrophobia, advanced or end-stage renal disease (ESRD) (contraindication to gadolinium), pregnancy, cognitive disabilities that may impair ability to comply with instructions or provide informed consent
Has difficulty with or is unable to swallow oral medication or has significant. gastrointestinal disease that would limit absorption of oral medication
Known history of infection with HIV or any active significant infection (e.g., bacterial, viral, or fungal) including subjects with positive cytomegalovirus \[CMV\] deoxyribonucleic acid \[DNA\] polymerase chain reaction \[PCR\])
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 AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenic purpura)
Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening
Requires treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor/inducer. The use of strong CYP3A inhibitors within 1 week or strong CYP3A inducers within 3 weeks of the first dose of study drug is prohibited
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
Requires treatment with proton pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Note: Subjects receiving proton pump inhibitors who switch to H2-receptor antagonists or antacids are eligible for enrollment to this study
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
Received a live virus vaccination within 28 days of first dose of study drug
History of or ongoing confirmed progressive multifocal leukoencephalopathy (PML)
Received any investigational drug within 30 days or 5 half-lives (whichever is shorter) before 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 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
Concurrent participation in another therapeutic clinical trial
What this trial measures
- Cardiac magnetic resonance imaging changesBaseline to 3-month post acalabrutinib initiation
The cardiac MRI changes that will be assessed include Extracellular volume (ECV), Native T1, and T2, where changes in ECV from baseline to 3-month post acalabrutinib initiation would be the primary endpoint