This study focuses on chronic lymphocytic leukemia, a type of cancer that affects the blood and bone marrow. The study is specifically for patients who have not received any previous treatment for this condition and who are experiencing symptoms related to their disease. The treatment being tested is pirtobrutinib, which is a medication that blocks certain proteins involved in cancer cell growth. This medication will be given in combination with a short course of immuno-chemotherapy, which means a mix of drugs that help the immune system fight cancer cells and drugs that directly kill cancer cells. The purpose of the study is to evaluate how well this combination treatment works when given for a fixed period of time.
During the study, participants will receive pirtobrutinib as a film-coated tablet taken by mouth along with the immuno-chemotherapy treatment. The medication will be given according to a specific schedule, with the maximum daily dose being 200 mg. The treatment period can last up to 420 days, which is approximately 14 months. Throughout the study, doctors will monitor how well the treatment is working by checking for the presence of cancer cells in the blood and bone marrow at different time points, including at 9 months, 18 months, and 24 months after starting treatment.
The study will track several important measures over time, including how long patients remain free from disease progression, how long they survive overall, and how long it takes before they need another treatment. Participants will need to attend regular study visits for evaluations and monitoring. The study requires that participants be at least 18 years old, have adequate blood counts and organ function, and be able to take oral medications. Patients must also have received vaccination against SARS-CoV-2 and will need testing before each treatment cycle if clinically indicated.
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