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.
PRIMARY OBJECTIVE: I. To determine cardiac magnetic resonance imaging (MRI) changes over time in patients with CLL who are intolerant to ibrutinib and switch to acalabrutinib therapy. SECONDARY OBJECTIVES: I. To determine the rate of recurrence of \>= grade 2 adverse events (AEs) causing ibrutinib intolerance at 1 year when patients with CLL/SLL are treated with acalabrutinib. II. To determine the response rates which include (complete response \[CR\], partial response \[PR\], PR with lymphocytosis). III. To determine C481S/PLCG2 mutation free (defined 0 mutation bearing alleles) and clinical progression free survival at 3 years. IV. To assess atrial fibrillation (AF) rates at 12 months post acalabrutinib transition. EXPLORATORY OBJECTIVES: I. To determine cardiac injury (i.e., troponin-TnT and N-terminal pro B-type natriuretic peptide \[NT-proBNP\]), C-reactive protein (CRP), and pro-inflammatory (ex. interleukin \[IL\]-6, IL-17, and tumor necrosis factor \[TNF\]-α, etc.) biomarkers. II. To assess fibrosis, serum procollagen type I carboxy-terminal propeptide (PICP), galectin-3, transforming growth factor (TGF)-β1, and matrix metalloproteinases (MMPs)-2, and -7 will be collected and measured at each timepoint. III. To determine cardiac magnetic resonance imaging (CMR) imaging changes that may be induced by acalabrutinib over time in BTK naive patients. OUTLINE: Patients receive acalabrutinib orally (PO) twice daily (BID) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CMR, computed tomography (CT), bone marrow aspiration/biopsy, and collection of blood samples throughout the trial. After completion of study treatment, patients are followed up every 6 months for up to 10 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
61
Given PO
Undergo collection of blood samples
Undergo bone marrow aspiration
Undergo bone marrow biopsy
Undergo CT
Undergo CMR
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
RECRUITINGCardiac magnetic resonance imaging changes
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
Time frame: Baseline to 3-month post acalabrutinib initiation
Overall response rate (ORR)
ORR will be defined as the number of patients with a response (complete response \[CR\], partial response \[PR\], PR with lymphocytosis) divided by the number of eligible patients who start study treatment. Response rates including CR and ORR will be estimated at the end of treatment and at various time points with exact 95% confidence intervals. The change in response over time will be presented in a descriptive manner as well as graphically through use of a Sankey plot.
Time frame: At the end of cycle 24 (1 cycle = 28 days)
Clinical progression free survival (PFS)
PFS will be described using the method of Kaplan-Meier and estimates at 3 years will be provided with 95% confidence intervals.
Time frame: From start of study treatment until first progression or death, assessed at 3 years
C481S/PLCG2 mutation free survival
Mutation free survival will be described using the method of Kaplan-Meier and estimates at 3 years will be provided with 95% confidence intervals.
Time frame: At 3 years
Incidence of recurrence of grade 2 or greater adverse events (AEs) that previously led to ibrutinib intolerance
The recurrence rate will be calculated as the number of patients who have recurrence (grade 2 or higher) of the AE that previously led to ibrutinib intolerance during the first 12 cycles of single agent acalabrutinib therapy divided by the number of eligible patients who start acalabrutinib therapy. The rate of recurrence of grade 2 or greater AEs will be analyzed using an exact binomial test for a single proportion and will be estimated with exact 95% confidence intervals.
Time frame: During the first 12 cycles of single agent acalabrutinib (1 cycle = 28 days)
Atrial fibrillation (AF) rates
AF rates will be calculated as the number of patients having AF (any grade) during the first 12 cycles of single agent acalabrutinib divided by the number of eligible patients who start acalabrutinib therapy.
Time frame: At 12 months post acalabrutinib transition
The Ohio State University Comprehensive Cancer Center
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.