Clinical Trials Using Tisagenlecleucel
Clinical trials are research studies that involve people. The clinical trials on this list are studying Tisagenlecleucel. All trials on the list are supported by NCI.
NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.
Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients
This is a single arm, open-label, multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in de novo HR pediatric and young adult B-ALL patients who received first-line treatment and are EOC MRD positive. The study will have the following sequential phases: screening, pre-treatment, treatment & follow-up, and survival. After tisagenlecleucel infusion, patient will have assessments performed more frequently in the first month and then at Day 29, then every 3 months for the first year, every 6 months for the second year, then yearly until the end of the study. Efficacy and safety will be assessed at study visits and as clinically indicated throughout the study. The study is expected to end in approximately 8 years after first patient first treatment (FPFT). A post-study long term follow-up for lentiviral vector safety will continue under a separate protocol per health authority guidelines.
Location: 24 locations
Tisagenlecleucel in Adult Patients With Aggressive B-cell Non-Hodgkin Lymphoma
This is a randomized, open label, multicenter phase III trial comparing the efficacy, safety, and tolerability of tisagenlecleucel to Standard Of Care in adult patients with aggressive B-cell Non-Hodgkin Lymphoma after failure of rituximab and anthracycline containing frontline immunochemotherapy.
Location: 17 locations
Phase II Open Label Trial to Determine Safety & Efficacy of Tisagenlecleucel in Pediatric Non-Hodgkin Lymphoma Patients
The purpose of the study is to assess the efficacy and safety of tisagenlecleucel in children and adolescents with relapsed / refractory B-cell non-Hodgkin lymphoma (r / r B-NHL). For pediatric patients who have r / r B-NHL, survival rates are dismal, only ~20-50% subjects are alive at 2 years with overall response rate (ORR) of 20-30% after conventional salvage chemotherapy.
Location: 11 locations
Study of Tisagenlecleucel in Combination With Pembrolizumab in r / r Diffuse Large B-cell Lymphoma Patients
A multi-center, open-label, phase Ib study to evaluate the safety and efficacy of the administration of tisagenlecleucel in combination with pembrolizumab in patients with r / r DLBCL who have received 2 or more lines of systemic therapy, including an anti-CD20 and anthracycline based chemotherapy and having failed to or are not candidates for ASCT. The study will consist of 2 parts: dose timing selection part and expansion part.
Location: 5 locations
Genetically Modified T-Cells in Treating Patients With Advanced Non-Hodgkin's Lymphoma
This phase I trial studies the side effects and the best dose of genetically modified T-cells in treating patients with advanced non-Hodgkin's lymphoma. Biological therapies, such as genetically modified T-cells may stimulate or suppress the immune system in different ways and stop cancer cells from growing.
Location: 3 locations
Genetically Modified Cells (CART19) for the Treatment of Pediatric B cell Acute Lymphoblastic Leukemia
This phase II trial studies how well CART19 works in treating pediatric B cell acute lymphoblastic leukemia. CART19 cells are modified cells which are produced by taking a patient's white blood cells (T cells) and changing them in a way that allows the cells to identify and kill patient's cancer cells. This change tells the T cells to go to the cancer cells and turn "on" and potentially kill the cancer cells. The modification is done by gene transfer and results in a genetic change to the T cells. This allows the changed T cells to recognize cancer cells and normal antibody-producing cells called B cells, but not other normal cells in the body.
Location: Children's Hospital of Philadelphia, Philadelphia, Pennsylvania
Tisagenlecleucel for the Treatment of Primary Central Nervous System Lymphoma
This phase I trial studies the side effects of tisagenlecleucel in treating patients with primary central nervous system lymphoma. Tisagenlecleucel is an investigational treatment that uses a patient's own immune cells, called T cells, to try to kill the cancerous cells. T cells fight infections and can also kill cancer cells in some cases. In this study, some T cells will be removed from the blood, changed in a laboratory, and then given back by intravenous infusion. While in the laboratory, new genetic material will be placed into the T cells. T cells that have genetic material added are called genetically changed T cells. If the genetically changed T cells recognize and attach to cancer cells, they may have the ability to become activated and kill them.
Location: Massachusetts General Hospital Cancer Center, Boston, Massachusetts
Study of Efficacy and Safety of Reinfusion of Tisagenlecleucel in Pediatric and Young Adult Patients With Acute Lymphoblastic Leukemia (ALL)
This is a multi-center Phase II study investigating the efficacy and safety of reinfusion of tisagenlecleucel in pediatric and young adult patients with ALL who were treated with tisagenlecleucel and experience B cell recovery.
Location: UCSF Medical Center-Mission Bay, San Francisco, California
A Study of Itacitinib for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy
The purpose of this study is to assess the safety and efficacy of oral administration of itacitinib once daily for the prevention of cytokine release syndrome (CRS) in male or female participants aged 12 years or older and who are planning to receive tisagenlecleucel or axicabtagene ciloleucel immune effector cell (IEC) therapy for any approved hematologic indication.
Location: 8 locations
Chimeric Antigen Receptor (CAR)-T Cell Therapy for Patients with Blood Cancer
This phase II study investigates how well tisagenlecleucel (Kymriah) and axicabtagene ciloleucel (Yescarta) work in treating patients with CD19 positive acute lymphoblastic leukemia, large B-cell lymphoma, or diffuse large B cell lymphoma that has come back (recurrent) or does not respond to treatment (refractory). Tisagenlecleucel and axicabtagene ciloleucel are types of CAR-T therapy. Immunotherapy with tisagenlecleucel or axicabtagene ciloleucel, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. The purpose of this study is to collect information on CAR-T product treatment and provide a structure to save and report data on treatment using these products.
Location: University of Minnesota / Masonic Cancer Center, Minneapolis, Minnesota