About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
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
Trial design
Treatments tested in this trial
- Acalabrutinib
- Biospecimen Collection
- Bone Marrow Aspiration
- Bone Marrow Biopsy
- Computed Tomography
- Magnetic Resonance Imaging of the Heart
Treatment groups
Sponsors and collaborators
Seema Bhat
Lead sponsor
Ohio State University Comprehensive Cancer Center
Sponsor institution
Acerta Pharma, LLC
Collaborator
AstraZeneca
Collaborator