Evaluation of the Safety and Efficacy of the Association of Ibrutinib and Daratumumab in Relapsed/Refractory Chronic Lymphocytic Leukemia With p53 Dysfunction

To join this study, you need to be an adult over 18 years old and have chronic lymphocytic leukemia (CLL) that has either come back after previous treatment or hasn't responded to it. Your CLL cells must also show a specific genetic change, which doctors call a 'P53 genetic alteration' (like a 17p deletion or TP53 mutation).

You also need to be generally well enough to take part, meaning you can carry out most of your daily activities without too much difficulty. For women who could become pregnant, a negative pregnancy test is required before starting treatment. The medical team will check your overall health and make sure you can understand what's involved in the study.

However, some conditions would mean you can't join. For example, if you've been treated with ibrutinib before, or if you have certain other serious health issues like uncontrolled infections, or severe lung conditions. People with HIV or active Hepatitis B or C also wouldn't be able to participate, nor would those who've had severe allergic reactions to similar types of medicine.

If you decide to take part in this study, there will be several stages. First, there's an 'observational period' of up to 28 days where a lot of checks will be done. This includes reviewing your medical history, having a physical exam, blood tests (to check how your body is working, look for viruses, and specifically examine your CLL cells), urine tests, a CT scan to look at your internal organs, and a heart check (ECG).

After these initial checks, you'll start the treatment period. For the first 28 days, you'll receive ibrutinib on its own. After that, you'll take both ibrutinib and daratumumab together. You'll continue with both drugs for as long as they are helping and you're not experiencing too many side effects. During this time, you'll have regular hospital visits, including physical exams and blood tests, to monitor your health and the cancer. After 12 months, there will be a more thorough check-up, including a CT scan and possibly a bone marrow test. These assessments will continue regularly every 6 months after that. The treatment will stop if your disease gets worse or if the side effects become too much to handle.

Once you stop taking the study drugs, you'll enter a 'follow-up period' that will last for two years. During this time, the medical team will continue to monitor your health and the progress of your CLL.