A Phase II, single arm, multicenter open label trial to
determine the efficacy and safety of tisagenlecleucel
(CTL019) in adult patients with refractory or relapsed
The purpose of the study is to learn about a cell therapy called CTL019 that may be helpful in treating Follicular Lymphoma. It is also known as tisagenlecleucel, and commercially these cells are called KymriahTM. CTL019 will be called the “study T cells” throughout this form. We do not know if the study T cells will work. The study T cells have not been approved by the Food and Drug Administration (FDA) to be used for relapsed or refractory follicular lymphoma.
We are hoping to find out if the treatment with study T cells in adult participants with follicular lymphoma is a safe and effective option.
Relapsed/Refractory Follicular Lymphoma
- Greater than 18 years of age
- Relapsed or Refractory Follicular Lymphoma
- No prior anti-CD19, gene, or adoptive T cell therapies
- No prior allogeneic stem cell transplant
- No active CNS involvement
- No active neurological autoimmune or inflammatory disorders (such as Guillan-Barre syndrome or Amyotrophic Lateral Sclerosis)
- You cannot be pregnant or nursing
18 - 120
Healthy Volunteers Needed
Duration of Participation
Your participation in the study will consist of 26 to 30 visits over 2 to 4 years. Visits will last up to 6 to 8 hours on infusion days and 1-3 hours on non-infusion days. Upon completion of this study, we will ask to follow your health over the next 15 years by asking you to participate in a separate, long term safety follow up study for participants who have been exposed to study T cells.
Knight Cancer Intake Center: (503) 494-7999
Clinical Trials Information Line: (503) 494-1080 or firstname.lastname@example.org
Novartis Pharmaceuticals, Inc.