This clinical trial is focused on studying treatments for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), which are types of blood cancers. The study will use three different treatment combinations: Venetoclax with Obinutuzumab, and two variations of Venetoclax with Pirtobrutinib. Venetoclax is a medication that comes in the form of a film-coated tablet, while Obinutuzumab is given as a solution for infusion, meaning it is administered directly into the bloodstream. Pirtobrutinib is also a tablet taken orally.
The purpose of the study is to compare the effectiveness of these treatments in patients who have not received prior treatment for their CLL or SLL. The study will look at how long patients live without their disease getting worse, which is known as progression-free survival. The trial will also explore how the treatment duration can be adjusted based on the measurement of individual residual disease, which refers to the small number of cancer cells that might remain after treatment.
Participants in the study will receive one of the treatment combinations for a set number of cycles. The study will monitor various outcomes, including the overall response to the treatment, the duration of the response, and the time until the next treatment is needed. Safety will also be closely monitored by tracking any adverse events. The study aims to improve treatment outcomes by tailoring the duration of therapy to each patient’s needs.
1joining the trial
Upon joining the trial, the patient will be randomly assigned to one of the treatment groups. This is done to ensure that the study results are unbiased and reliable.
2treatment with venetoclax and obinutuzumab
In this group, the patient will receive a combination of venetoclax and obinutuzumab. Venetoclax is taken orally as a film-coated tablet. Obinutuzumab is administered intravenously, which means it is given through a vein.
The treatment lasts for a fixed duration of 12 cycles. Each cycle typically lasts about one month, but the exact schedule will be provided by the healthcare team.
3treatment with venetoclax and pirtobrutinib
In this group, the patient will receive a combination of venetoclax and pirtobrutinib. Both medications are taken orally as film-coated tablets.
The treatment lasts for a fixed duration of 15 cycles. Each cycle typically lasts about one month, but the exact schedule will be provided by the healthcare team.
4MRD-guided treatment with venetoclax and pirtobrutinib
In this group, the patient will receive a combination of venetoclax and pirtobrutinib, similar to the previous group. However, the duration of treatment is guided by the measurement of measurable residual disease (MRD). This means that the treatment duration may be adjusted based on the patient’s response to the medication.
The healthcare team will monitor the patient’s response and adjust the treatment duration accordingly.
5monitoring and follow-up
Throughout the trial, the patient will have regular check-ups and tests to monitor their health and response to the treatment. This includes measuring the levels of measurable residual disease (MRD) and other health indicators.
The healthcare team will provide detailed instructions on the schedule and types of tests required.
6end of treatment and final assessment
After completing the treatment cycles, the patient will undergo a final assessment. This includes a comprehensive evaluation of their health and the effectiveness of the treatment.
The healthcare team will discuss the results and any further steps that may be necessary.
Who Can Join the Study?
Must have a documented diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that requires treatment.
Must have adequate bone marrow function, which means:
An absolute neutrophil count (a type of white blood cell) of at least 1 x 109/L.
A hemoglobin level (a protein in red blood cells) of at least 8.0 g/dL without needing a blood transfusion in the last 7 days, unless the low level is directly due to CLL/SLL.
A platelet count (cells that help with blood clotting) of at least 25 x 109/L, unless the low count is due to CLL/SLL, in which case it should be at least 10,000/µL without a transfusion in the last 7 days.
Must have adequate kidney function, shown by a creatinine clearance (a measure of kidney function) of at least 30 ml/min.
Must have adequate liver function, which means:
Total bilirubin (a substance made by the liver) should be no more than 2 times the normal upper limit, unless due to CLL/SLL or Gilbert’s Syndrome.
AST/ALT (liver enzymes) should be no more than 2.5 times the normal upper limit, unless due to CLL/SLL.
Must test negative for hepatitis B, hepatitis C, and HIV within 6 weeks before joining the study.
Must be at least 18 years old.
Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status, which is a measure of daily living abilities.
Must have a life expectancy of at least 6 months.
Must be able and willing to provide written informed consent and follow the study visit schedule and other requirements.
Who Cannot Join the Study?
Patients with any other type of cancer that is not chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) cannot participate.
Patients who have previously received treatment for CLL or SLL are not eligible.
Patients with severe heart problems, such as heart failure or recent heart attack, are excluded.
Patients with uncontrolled high blood pressure cannot join the study.
Patients with active infections that require treatment with antibiotics, antifungals, or antivirals are not allowed.
Patients with a history of other serious medical conditions that could interfere with the study are excluded.
Pregnant or breastfeeding women cannot participate in the study.
Patients who are unable to follow the study procedures or comply with the study requirements are not eligible.
Venetoclax is a medication used in this trial to treat chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). It works by targeting a specific protein in cancer cells that helps them survive. By blocking this protein, venetoclax can help kill cancer cells and slow down the progression of the disease.
Obinutuzumab is another medication used in the trial. It is a type of antibody therapy that targets cancer cells. Obinutuzumab attaches to a specific protein on the surface of cancer cells, marking them for destruction by the body’s immune system. This helps to reduce the number of cancer cells in the body.
Pirtobrutinib is a medication being tested in this trial for its effectiveness in treating CLL and SLL. It works by blocking a protein that is important for the growth and survival of cancer cells. By inhibiting this protein, pirtobrutinib may help to stop the cancer from growing and spreading.
Chronic Lymphocytic Leukemia (CLL) – Chronic Lymphocytic Leukemia is a type of cancer that affects the blood and bone marrow. It typically progresses slowly and is characterized by the accumulation of abnormal lymphocytes, a type of white blood cell. These abnormal cells can crowd out healthy blood cells, leading to symptoms such as fatigue, infections, and swollen lymph nodes. Over time, the disease can cause the spleen and liver to enlarge. As CLL progresses, it may interfere with the production of other blood cells, leading to anemia and increased bleeding. The disease can transform into a more aggressive form of lymphoma in some cases.
Small Lymphocytic Lymphoma (SLL) – Small Lymphocytic Lymphoma is a type of non-Hodgkin lymphoma that primarily affects the lymph nodes. It is closely related to Chronic Lymphocytic Leukemia, with the main difference being the location of the cancer cells. In SLL, the cancerous lymphocytes are mainly found in the lymph nodes, whereas in CLL, they are primarily in the blood and bone marrow. The disease progresses slowly and can lead to symptoms such as painless swelling of the lymph nodes, fatigue, and night sweats. As it advances, SLL can affect other organs and tissues, including the spleen and liver. The disease may eventually transform into a more aggressive form of lymphoma.
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