Acalabrutinib for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSeema Bhat

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

61 Participants
are divided into 1 treatment group

Sponsors and collaborators

Seema Bhat

Lead sponsor

Ohio State University Comprehensive Cancer Center

Sponsor institution

Acerta Pharma, LLC

Collaborator

AstraZeneca

Collaborator