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 two types of blood cancers: Classical Hodgkin Lymphoma and Non-Hodgkin Lymphoma. These are conditions where the body's lymphatic system, which is part of the immune system, develops cancerous cells. The study is testing a combination of two medications, Relatlimab and Nivolumab, to see how safe and effective they are for treating these cancers in children and young adults. Relatlimab is given as an injection, while Nivolumab is provided as an infusion, both administered directly into the bloodstream.
The purpose of the study is to understand how well these medications work together and how the body handles them. Participants will receive the treatment and be monitored for any side effects and how their cancer responds. The study is divided into two parts: the first part focuses on children under 18 years old to determine the safest dose, and the second part includes young adults up to 30 years old to assess how well the treatment works based on the findings from the first part.
Throughout the study, participants will undergo regular check-ups and tests to monitor their health and the progress of their treatment. The goal is to find a new, effective treatment option for those whose cancer has returned or not responded to standard therapies. This study is an important step in exploring new ways to help young patients with these challenging conditions.
The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.
14 criteria
9 criteria
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is a type of medication known as an immune checkpoint inhibitor. It works by helping the body's immune system recognize and attack cancer cells more effectively. In this trial, it is being tested in combination with another medication to see if it can help treat certain types of lymphoma, which are cancers of the lymphatic system.
is another immune checkpoint inhibitor. It helps the immune system fight cancer by blocking a protein that prevents immune cells from attacking cancer cells. In this study, it is used together with Relatlimab to see if the combination can improve treatment outcomes for young patients with specific types of lymphoma.
Relatlimab is administered through an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its potential use in treating recurrent or refractory classical Hodgkin lymphoma and non-Hodgkin lymphoma, particularly in pediatric and young adult patients. The medication works by targeting and blocking a specific protein on immune cells, which helps the body's immune system recognize and attack cancer cells more effectively. Relatlimab is classified as an immune checkpoint inhibitor, a type of drug that helps to boost the immune response against cancer.
Nivolumab is also administered via intravenous infusion, allowing it to enter the bloodstream directly. It is being investigated in combination with relatlimab for its effectiveness in treating recurrent or refractory classical Hodgkin lymphoma and non-Hodgkin lymphoma in younger patients. Nivolumab functions by inhibiting a protein that normally suppresses the immune system, thereby enhancing the body's ability to fight cancer cells. It belongs to the pharmacological class of immune checkpoint inhibitors, which are designed to strengthen the immune system's response to cancer.
Classical Hodgkin Lymphoma is a type of cancer that originates in the lymphatic system, which is part of the immune system. It is characterized by the presence of Reed-Sternberg cells, a specific type of abnormal cell. The disease often begins in the lymph nodes and can spread to other parts of the body, including the spleen, liver, and bone marrow. Symptoms may include painless swelling of lymph nodes, fever, night sweats, and weight loss. As the disease progresses, it can affect the body's ability to fight infections. The progression can vary, with some cases remaining localized while others spread more extensively.
Non-Hodgkin Lymphoma is a diverse group of blood cancers that develop in the lymphatic system. Unlike Hodgkin Lymphoma, it does not involve Reed-Sternberg cells. The disease can start in various types of white blood cells and can occur in lymph nodes or other lymphatic tissues. Symptoms may include swollen lymph nodes, fever, night sweats, and unexplained weight loss. The progression of Non-Hodgkin Lymphoma can vary widely, with some forms being slow-growing and others being more aggressive. It can spread to other parts of the body, including the liver, bone marrow, and spleen.
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