Prospective Phase 2 Study of the Effect of Acalabrutinib on Myocardium on Ibrutinib Exposed Patients With CLL
Seema Bhat
Summary
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.
Description
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 clin…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 im…
Interventions
- DrugAcalabrutinib
Given PO
- ProcedureBiospecimen Collection
Undergo collection of blood samples
- ProcedureBone Marrow Aspiration
Undergo bone marrow aspiration
- ProcedureBone Marrow Biopsy
Undergo bone marrow biopsy
- ProcedureComputed Tomography
Undergo CT
- ProcedureMagnetic Resonance Imaging of the Heart
Undergo CMR
Location
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio