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.
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: 13 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: 10 locations
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, efficacy will be assessed 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. Safety will be assessed 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: 13 locations
Efficacy and Safety of Tisagenlecleucel in Adult Patients With Refractory or Relapsed Follicular Lymphoma
This is a multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in adult patients with relapsed or refractory FL.
Location: 8 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
Study of Tisagenlecleucel in Combination With Ibrutinib in r / r Diffuse Large B-cell Lymphoma Patients
A multi-center, open-label, phase Ib study to evaluate the safety and tolerability of the administration of tisagenlecleucel in combination with ibrutinib in patients with r / r DLBCL who have received two or more lines of systemic therapy, including an anti-CD20 and anthracycline based chemotherapy, and who have progressed after or are not candidates for ASCT.
Location: 4 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
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
Tocilizumab for the Treatment of CART19 Associated Cytokine Release Syndrome in Patients with CD19 Positive Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia or B-cell Lymphoblastic Lymphoma
This early phase I trial studies how well tocilizumab works in treating cytokine release syndrome caused by treatment with CART19 T-cells (genetically modified white blood cells) in patients with CD19 positive B-cell acute lymphoblastic leukemia or B-cell lymphoblastic lymphoma that has come back (recurrent) or does not respond to treatment (refractory). Tocilizumab may help control cytokine release syndrome side effects in patients who are receiving treatment with CART19 T-cells for B-cell acute lymphoblastic leukemia or B-cell lymphoblastic lymphoma
Location: Children's Hospital of Philadelphia, Philadelphia, Pennsylvania
Determine Efficacy and Safety of CTL019 in Pediatric Patients With Relapsed and Refractory B-cell ALL and High Risk B-cell ALL at First Relapse. Determine Feasibility and Safety of CTL019 Therapy in Pediatric Patients With High Risk B-cell ALL That Relapsed < 6 Months Post All-HSCT.
This is a single arm, open-label, multi-center, phase II study to determine the efficacy and safety of CTL019 in pediatric patients with r / r B-cell ALL and high risk B-cell ALL at first relapse. Determine feasibility and safety of CTL019 therapy in pediatric patients with high risk B-cell ALL that relapsed < 6 months post allo-HSCT.
Location: 2 locations
Tisagenlecleucel vs Blinatumomab or Inotuzumab for Patients With Relapsed / Refractory B-cell Precursor Acute Lymphoblastic Leukemia
This trial aims to compare the benefits and risks of tisagenlecleucel to blinatumomab or inotuzumab in adult patients with relapsed or refractory ALL. This trial investigates tisagenlecleucel as an additional treatment option for this patient population with high unmet medical need.
Location: Emory University Hospital / Winship Cancer Institute, Atlanta, Georgia
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: Siteman Cancer Center at Washington University, Saint Louis, Missouri