In short
There is currently 1 ongoing clinical trial for patients with malignant lymphoid neoplasm. This trial focuses on long-term follow-up of patients who have received gene-modified T cell treatments, monitoring their safety and effectiveness over an extended period. The study is being conducted across 15 European countries.
Clinical trial locations
- Austria
- Belgium
- Denmark
- Finland
- France
- Germany
- Greece
- Italy
- Netherlands
- Norway
- Poland
- Portugal
- Romania
- Spain
- Sweden
Long-Term Follow-Up Study for Patients Treated with Idecabtagene Vicleucel or Lisocabtagene Maraleucel for Cancer
This clinical trial examines the long-term safety and effects of advanced gene therapy treatments in patients who have previously participated in studies sponsored by Celgene Corporation. The study specifically focuses on two types of gene-modified T cell therapies: idecabtagene vicleucel and lisocabtagene maraleucel.
Main focus: The primary goal is to monitor patients over an extended period to understand any delayed side effects that might occur after receiving these modified immune cell treatments. Researchers will track how long the modified cells remain in the body, watch for the development of any new health conditions, and assess whether any viruses emerge that could reproduce in the body. For younger patients who were under 18 when treated, the study will also monitor physical growth and sexual maturity to understand how the treatment affects development.
Who can participate: This trial is open to both adults and children who have received at least one infusion of genetically modified T cells in a previous Celgene-sponsored study. Participants must be willing to sign an informed consent form (or their parent or legal representative must sign if they are under 18), showing they understand the study and agree to take part. They must also be able to follow the scheduled visits and meet other study requirements.
Who cannot participate: Patients who have not received at least one infusion of genetically modified T cells in a previous Celgene-sponsored study are not eligible for this trial.
Investigational treatment: The study uses gene-modified T cells, which are a patient's own immune cells that have been altered in a laboratory to better recognize and fight cancer cells. These T cells are collected from the patient, modified to enhance their cancer-fighting abilities, and then returned to the patient's body. The goal is to strengthen the body's natural defense system against cancer. This type of therapy falls under gene therapy, which involves changing genes to treat or prevent disease.
The study follows a structured approach beginning with informed consent, followed by initial health assessments to establish baseline information. Throughout the trial, participants attend regular follow-up visits where researchers monitor for any new or worsening health conditions related to the treatment. The study includes detailed analysis of how long the modified cells persist in the body and checks for any safety concerns. For pediatric participants, additional assessments track growth and development to understand the treatment's impact on young bodies.
Summary
Currently, there is one ongoing clinical trial available for patients with malignant lymphoid neoplasm who have previously received gene-modified T cell therapy. This trial represents an important long-term safety monitoring effort, spanning 15 European countries including Finland, Belgium, Spain, France, Germany, Austria, Italy, Sweden, Netherlands, Poland, Norway, Greece, Denmark, Portugal, and Romania. The wide geographic distribution ensures that patients across Europe who participated in earlier treatment studies have access to continued monitoring and care.
The trial focuses specifically on two gene therapy treatments: idecabtagene vicleucel and lisocabtagene maraleucel. Both are advanced therapies that modify a patient's own immune cells to fight cancer more effectively. The study's emphasis on long-term follow-up is crucial for understanding the full safety profile of these innovative treatments and how they affect patients over time, particularly younger patients whose growth and development are being carefully tracked.
