Study on Acalabrutinib for Treating Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Sponsor: Ohio State University Comprehensive Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06757647

Provider View

This clinical trial is exploring how well the drug acalabrutinib works in treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), especially those who have heart issues with another treatment called ibrutinib.

Patient Parameters

Program Overview

This study is testing the effectiveness of acalabrutinib, a medication that blocks a protein called BTK, which is found at high levels in certain cancer cells. By blocking this protein, acalabrutinib may help stop cancer cells from growing and spreading. The trial is particularly focused on patients with CLL or SLL who have experienced heart-related side effects from another BTK inhibitor, ibrutinib. The study aims to see if switching to acalabrutinib can prevent or reverse these side effects while effectively treating the cancer.

Description

The main goal of this study is to observe changes in heart function over time in patients with CLL who cannot tolerate ibrutinib and switch to acalabrutinib. Researchers will also look at how often serious side effects return after switching to acalabrutinib, how well patients respond to the treatment, and how long they remain free of disease progression. Additionally, the study will monitor heart health indicators and any changes in heart imaging over time.

Participants will take acalabrutinib by mouth twice a day in 28-day cycles, continuing as long as the treatment is effective and side effects are manageable. Throughout the study, patients will undergo various tests, including heart imaging, CT scans, bone marrow tests, and blood sample collections. After completing the treatment, patients will have follow-up visits every six months for up to ten years.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older.
  • Diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
  • Have heart issues related to current treatment with ibrutinib, such as atrial fibrillation or other heart rhythm problems.
  • General health status allowing for daily activities with some limitations.
  • Sufficient blood cell counts and organ function based on specific medical tests.
  • Women of childbearing potential must use effective birth control during treatment and for two days after the last dose.
  • Willing to participate in all study evaluations and procedures.
  • Able to understand the study and provide informed consent.

Exclusion Criteria

  • Previous treatment with acalabrutinib or other BTK inhibitors.
  • Specific genetic mutations related to the disease.
  • Disease progression while on ibrutinib.
  • History of other cancers that could interfere with the study, except for certain skin or cervical cancers treated successfully.
  • Significant heart disease or prior heart transplants.
  • Use of certain medications that could interfere with the study.
  • Conditions that prevent MRI scans, such as certain metal implants or severe claustrophobia.
  • Difficulty swallowing pills or significant digestive issues.
  • Active infections, including HIV or hepatitis B/C, unless controlled.
  • History of severe allergic reactions to study drugs.
  • Active bleeding disorders or recent gastrointestinal ulcers.
  • Recent major surgery or live vaccinations.
  • Pregnant or breastfeeding women.
  • Participation in another clinical trial.

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