This clinical trial is focused on studying treatments for chronic lymphocytic leukemia (CLL), a type of cancer that affects the blood and bone marrow. The study involves three different treatment approaches. The first treatment is Ibrutinib, which is taken as a monotherapy, meaning it is used alone. The second treatment combines Venetoclax with Obinutuzumab, and the third treatment combines Venetoclax with Ibrutinib. Venetoclax is a medication that helps to kill cancer cells, and Obinutuzumab is an antibody that targets specific cancer cells. The purpose of the study is to compare the effectiveness of these treatments in patients who have not received any prior treatment for their CLL.
Participants in the study will be randomly assigned to one of the three treatment groups. Those receiving Ibrutinib will take it continuously, while those in the other two groups will receive their treatments for a fixed duration. The study will monitor the participants over time to see how well the treatments work in preventing the progression of the disease. This is known as measuring progression-free survival, which means the length of time during and after treatment that the patient lives with the disease without it getting worse.
The study will also look at other outcomes, such as the overall response rate, which measures how well the cancer responds to the treatment, and the duration of response, which is how long the response lasts. Additionally, the study will assess the overall survival of participants, which is the length of time from the start of the study that patients are still alive. By comparing these outcomes, the study aims to determine which treatment approach is most effective for patients with previously untreated chronic lymphocytic leukemia.
1initial treatment phase
The trial begins with the administration of medications based on the assigned treatment group. The options include ibrutinib monotherapy, venetoclax plus obinutuzumab, or venetoclax plus ibrutinib.
For those receiving ibrutinib monotherapy, the medication is taken orally in the form of 140 mg hard capsules. The dosage and frequency are determined by the healthcare provider.
Participants in the venetoclax plus obinutuzumab group receive obinutuzumab intravenously as a solution for infusion. Venetoclax is administered orally as film-coated tablets.
In the venetoclax plus ibrutinib group, both medications are taken orally. Venetoclax is provided as film-coated tablets, and ibrutinib as hard capsules.
2treatment duration
The duration of treatment varies depending on the group. Ibrutinib is administered continuously, while the venetoclax combinations are given for a fixed duration.
The specific duration and schedule for each medication are outlined by the healthcare provider and are based on the trial protocol.
3monitoring and assessments
Throughout the trial, regular monitoring and assessments are conducted to evaluate the effectiveness of the treatment.
Progression-free survival (PFS) is a primary measure, assessing the time during and after treatment that the patient lives without the disease worsening.
Secondary assessments include measuring the levels of minimal residual disease (MRD) in blood and bone marrow, overall response rate, and overall survival.
4final restaging
At the end of the treatment cycles, a final restaging occurs to evaluate the response to the treatment.
This includes assessments of MRD levels and overall response according to established guidelines.
5follow-up
After the treatment phase, follow-up visits are scheduled to monitor long-term outcomes and any potential late effects of the treatment.
These visits may continue every six months until the end of the study, which is estimated to conclude in September 2027.
Who Can Join the Study?
You must have a documented case of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that needs treatment.
You must be at least 18 years old.
You should have a life expectancy of at least 6 months.
You need to be able and willing to provide written consent and follow the study schedule and requirements.
Your bone marrow should function well without needing extra support like growth factors or transfusions, unless low blood counts are due to CLL. This means:
Your neutrophil count (a type of white blood cell) should be at least 1.0 x 109/L.
Your platelet count (cells that help with blood clotting) should be at least 30 x 109/L, or at least 10 x 109/L if low due to CLL.
Your hemoglobin level (a protein in red blood cells) should be at least 8 g/dL without needing transfusions, unless low due to CLL.
Your kidney function should be good, with a glomerular filtration rate (GFR) over 30 ml/min. This can be measured directly or calculated using a formula. If your creatinine level (a waste product in the blood) is normal, this calculation isn’t needed.
Your liver function should be adequate, with bilirubin levels no more than twice the normal limit and AST/ALT levels no more than 2.5 times the normal limit, unless these are high due to CLL or a condition called Gilbert’s Syndrome.
You must test negative for hepatitis B and hepatitis C. If you have antibodies for hepatitis B, a negative DNA test is needed, and regular testing is required. If you have antibodies for hepatitis C, a negative PCR test is needed.
Your performance status, which measures your ability to perform daily activities, should be between 0 and 2 on the Eastern Cooperative Oncology Group (ECOG) scale.
Who Cannot Join the Study?
Patients who have already received treatment for their chronic lymphocytic leukemia (CLL) cannot participate. This means if you have been treated for CLL before, you are not eligible.
Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
Patients who are part of a vulnerable population, which means they might need special protection or care, are not eligible for this study.
Ibrutinib is a medication used in this trial as a continuous treatment option. It works by blocking a specific protein that helps cancer cells grow and survive. This medication is being tested to see how well it can control chronic lymphocytic leukemia (CLL) when used alone over a long period.
Venetoclax is another medication in the trial, used in combination with other treatments for a fixed period. It helps to kill cancer cells by targeting a protein that prevents them from dying. This study is examining how effective it is when used for a set duration in treating CLL.
Obinutuzumab is used in combination with venetoclax for a fixed duration in this trial. It is an antibody that attaches to cancer cells and helps the immune system destroy them. The trial is investigating how well this combination works in treating CLL over a specific period.
Chronic Lymphocytic Leukemia – Chronic lymphocytic leukemia (CLL) is a type of cancer that affects the blood and bone marrow. It is characterized by the production of an excessive number of abnormal lymphocytes, a type of white blood cell. These abnormal cells accumulate over time, leading to a gradual increase in their numbers in the blood and bone marrow. As the disease progresses, it can interfere with the production of normal blood cells, leading to symptoms such as fatigue, swollen lymph nodes, and an increased risk of infections. CLL typically progresses slowly, and many individuals may not experience symptoms for years. The disease is often diagnosed through routine blood tests that reveal high levels of lymphocytes.
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