This clinical trial is focused on understanding the long-term effects of treatments involving gene-modified T cells. These treatments are used for patients who have previously participated in studies sponsored by Celgene Corporation. The study includes patients who have received at least one infusion of these specially modified cells. The main goal is to assess any delayed side effects that might occur after receiving these treatments. The study will also monitor how long these modified cells remain in the body and check for any potential issues, such as the development of new viruses or changes in the patient’s health status over time.
The trial involves two specific treatments: idecabtagene vicleucel and lisocabtagene maraleucel. These are advanced therapies that use a patient’s own immune cells, which are modified to better fight certain diseases. The study will follow patients over a long period to ensure their safety and to gather information on the effectiveness of these treatments. This includes looking at any new health conditions that might arise and tracking the overall health and development of younger patients who received the treatment.
Throughout the study, researchers will collect data on various health aspects, such as the presence of the modified cells in the body and any new health issues that could be linked to the treatment. The study aims to provide a comprehensive understanding of the long-term safety and benefits of using **gene-modified T cells** in treating diseases. This information will help improve future treatments and ensure they are safe and effective for patients.
1joining the study
Upon joining the study, it is necessary to sign an informed consent form. This form confirms understanding of the study and agreement to participate.
For participants under 18, a parent or legal representative must also sign an informed assent form.
2initial assessment
An initial assessment is conducted to gather baseline information. This may include a physical examination and review of medical history.
The purpose is to ensure eligibility and gather data for future comparisons.
3treatment monitoring
Participants who have previously received genetically modified T cells will be monitored for delayed adverse events. This includes checking for new or worsening conditions.
Regular follow-up visits are scheduled to assess the long-term effects of the treatment.
4long-term follow-up
The study involves long-term follow-up to monitor the persistence of genetically modified T cells in the body.
This includes analysis of the cells and checking for any replication-competent lentiviruses, which are viruses that can reproduce.
5growth and maturity assessment
For participants under 18 at the time of treatment, assessments of physical growth and sexual maturity are conducted.
These assessments help understand the impact of the treatment on development.
6safety and efficacy evaluation
The study evaluates the safety of the treatment by monitoring for any new health issues related to the therapy.
The efficacy of the treatment is also assessed by tracking disease status, progression, and overall survival.
Who Can Join the Study?
All adult and pediatric subjects who have received at least one infusion of genetically modified (GM) T cells in a previous study sponsored by Celgene or its partners.
The subject, or their parent/legal representative if applicable, must understand and voluntarily sign an Informed Consent Form (ICF) or Informed Assent Form (IAF) before any study-related assessments or procedures are conducted. An Informed Consent Form is a document that explains the study and any potential risks, ensuring that participants understand and agree to take part.
The subject must be willing and able to follow the study visit schedule and other requirements of the study protocol.
Who Cannot Join the Study?
Patients who have not received at least one infusion of genetically modified T cells in a previous Celgene sponsored study.
Gene-Modified T Cells are a type of therapy where a patient’s own immune cells, specifically T cells, are altered in a laboratory to better recognize and attack cancer cells. This process involves collecting T cells from the patient, modifying them to enhance their ability to fight cancer, and then reintroducing them into the patient’s body. The goal of this therapy is to improve the body’s natural ability to combat cancer by using these enhanced T cells. In this trial, the focus is on understanding the long-term effects and safety of these modified cells, as well as their effectiveness in treating cancer over an extended period.
Neurologic Disorder – Neurologic disorders involve the nervous system, which includes the brain, spinal cord, and nerves. These disorders can affect movement, communication, and cognitive functions. Symptoms may develop gradually or suddenly and can include muscle weakness, coordination problems, and changes in sensation. Over time, these disorders may lead to increased difficulty in performing daily activities. The progression can vary widely depending on the specific type of neurologic disorder.
Rheumatologic Disorder – Rheumatologic disorders affect the joints, muscles, and bones, often causing pain, swelling, and stiffness. These conditions can lead to decreased mobility and function over time. Symptoms may fluctuate, with periods of increased activity and remission. As the disorder progresses, it can result in joint damage and deformities. The severity and progression can differ significantly among individuals.
Autoimmune Disorder – Autoimmune disorders occur when the immune system mistakenly attacks the body’s own tissues. This can lead to inflammation and damage in various organs and systems. Symptoms often include fatigue, fever, and general malaise, along with specific organ-related symptoms. The progression can be unpredictable, with periods of flare-ups and remission. Over time, chronic inflammation can lead to tissue damage and loss of function.
Hematologic Disorder – Hematologic disorders affect the blood and blood-forming organs, impacting the production and function of blood cells. These disorders can lead to symptoms such as fatigue, weakness, and increased susceptibility to infections. As the condition progresses, it may cause complications like anemia, bleeding disorders, or clotting issues. The progression and impact on health can vary depending on the specific type of hematologic disorder.
Infection – Infections are caused by microorganisms such as bacteria, viruses, fungi, or parasites invading the body. They can lead to symptoms like fever, fatigue, and localized pain or swelling. The progression of an infection depends on the type of microorganism and the body’s immune response. Some infections resolve quickly, while others can persist and cause chronic health issues. The severity and duration can vary widely among different infections.
Second Primary Malignancy (SPM) – A second primary malignancy is a new cancer that occurs in an individual who has previously been diagnosed with cancer. This new cancer is distinct from any recurrence or spread of the original cancer. The development of an SPM can be influenced by genetic factors, previous cancer treatments, or environmental exposures. The progression of an SPM depends on the type and location of the new cancer. It requires separate evaluation and management from the initial cancer.
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