Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
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 long-term safety of a treatment for certain types of blood cancers. The diseases being studied include Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma, Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL), and Relapsed/Refractory Multiple Myeloma. The treatment involves a type of cell therapy known as CAR T-cell therapy, which uses the body's own immune cells, called T cells, that are modified to better fight cancer. The specific treatments being tested are called BCMACP03, BCN-CP01, and 19CP02. These treatments are given as an infusion, which means they are delivered directly into the bloodstream through a vein.
The purpose of this study is to evaluate the long-term safety of these CAR T-cell therapies for up to 15 years after the treatment is given. Participants in the study will be monitored over this period to check for any side effects or health changes. This includes looking at the type and frequency of any adverse events, which are unexpected medical problems that occur during treatment. The study will also track the presence of the CAR T-cells in the blood and any changes in the disease status, such as progression or the need for additional cancer treatments.
Throughout the study, researchers will collect information on overall survival and any new health issues that may arise. This information will help determine the long-term effects of the CAR T-cell therapies and their safety for patients who have received them. The study aims to provide valuable insights into how these treatments work over time and their impact on patients' health.
The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.
4 criteria
6 criteria
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Woluwe-Saint-Lambert, Belgium
Rotterdam, The Netherlands
Leuven, Belgium
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This is a type of cancer that originates in the lymphatic system, specifically affecting B-cells, which are a type of white blood cell. The term "relapsed" refers to the return of the disease after treatment, while "refractory" indicates that the disease does not respond to treatment. It typically presents with symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. The disease can progress by spreading to other parts of the body, including the bone marrow and spleen. As it advances, it may lead to more severe symptoms and complications.
CLL and SLL are closely related types of cancer that affect the lymphocytes, a kind of white blood cell. In CLL, cancer cells are primarily found in the blood and bone marrow, while in SLL, they are mainly in the lymph nodes. "Relapsed" indicates the disease has returned after treatment, and "refractory" means it does not respond to treatment. Symptoms may include fatigue, swollen lymph nodes, and frequent infections. The disease can progress slowly, but over time, it may lead to more significant health issues.
This is a cancer of the plasma cells, which are a type of white blood cell found in the bone marrow. "Relapsed" means the cancer has returned after treatment, and "refractory" indicates it does not respond to treatment. It often causes bone pain, anemia, kidney problems, and high calcium levels in the blood. As the disease progresses, it can lead to bone fractures, severe infections, and other complications. The progression involves the accumulation of abnormal plasma cells in the bone marrow, affecting normal blood cell production.
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