ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Rare diseases
Investigational molecules
Locations
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying the effectiveness and safety of a new treatment approach for people with Chronic Lymphocytic Leukemia (CLL), a type of cancer that affects the blood and bone marrow. The study involves a combination of medications, including an investigational drug called acalabrutinib (also known as ACP-196), and two other drugs, venetoclax and obinutuzumab. These medications will be compared to standard chemotherapy treatments that are commonly used for CLL, such as combinations involving fludarabine, cyclophosphamide, and rituximab, or bendamustine and rituximab.
The purpose of this study is to evaluate how well the new combination of acalabrutinib, venetoclax, and obinutuzumab works compared to the traditional chemotherapy options. Participants in the study will be randomly assigned to receive either the new combination treatment or one of the standard chemotherapy treatments. The study will monitor participants over a period of time to assess the progression of the disease and any side effects experienced. The medications will be administered either orally or through intravenous infusion, depending on the specific drug.
This trial is designed for individuals who have not received prior treatment for their CLL and do not have certain genetic mutations, specifically the del(17p) or TP53 mutation. The study aims to provide valuable information on whether the new treatment combination can offer better outcomes for patients with CLL compared to existing chemotherapy options. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and to gather data on the effectiveness of the treatments.
The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.
8 criteria
4 criteria
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Milan, Italy
Budapest, Hungary
Plovdiv, Bulgaria
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This medication is used to treat certain types of blood cancers, including chronic lymphocytic leukemia. It works by blocking a specific protein in cancer cells, which helps to stop their growth and spread.
This is a medication that targets and blocks a protein that helps cancer cells survive. By inhibiting this protein, venetoclax can help to kill cancer cells and slow down the progression of the disease.
This is a type of therapy known as a monoclonal antibody. It works by attaching to specific proteins on the surface of cancer cells, marking them for destruction by the immune system.
This medication is a type of chemotherapy used to treat certain blood cancers. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing.
This is a chemotherapy drug that works by slowing or stopping the growth of cancer cells. It is often used in combination with other medications to treat various types of cancer.
This is a monoclonal antibody used to treat certain types of blood cancers. It works by targeting specific proteins on cancer cells, helping the immune system to recognize and destroy them.
Acalabrutinib is administered orally in the form of capsules. It is currently being studied in clinical trials for its effectiveness in treating chronic lymphocytic leukemia (CLL) without specific genetic mutations. The medication works by inhibiting a protein called Bruton's tyrosine kinase (BTK), which plays a role in the growth and survival of cancer cells. Acalabrutinib is classified as a targeted therapy, specifically a BTK inhibitor.
Venetoclax is taken orally as tablets. It is under investigation for its use in treating chronic lymphocytic leukemia (CLL) in patients without certain genetic mutations. The drug functions by blocking a protein called BCL-2, which helps cancer cells survive, thereby promoting their death. Venetoclax is classified as a BCL-2 inhibitor, a type of targeted therapy.
Obinutuzumab is administered intravenously. It is being evaluated in clinical trials for its potential to treat chronic lymphocytic leukemia (CLL) in combination with other medications. The drug targets a protein called CD20 on the surface of cancer cells, leading to their destruction. Obinutuzumab is classified as a monoclonal antibody, a form of immunotherapy.
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