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Tisagenlecleucel after optional bridging and lymphodepleting chemotherapy · 1 trial · 1 indication
Event-free survival (EFS) is defined as the time from the date of randomization to the date of the first documented disease progression or stable disease at or after the week 12 (+/- 1 week) assessment, as assessed by Blinded Independent Review Committee (BIRC) per Lugano criteria, or death due to any cause, at any time.
| Arm | Type | Description |
|---|---|---|
| Tisagenlecleucel treatment strategy | EXPERIMENTAL | Patients received investigator's choice of optional platinum-based immunochemotherapy followed by lymphodepleting chemotherapy and a single dose of tisagenlecleucel |
| Standard of care treatment strategy | ACTIVE_COMPARATOR | Patients received investigator's choice of platinum-based immunochemotherapy followed in responding patients by high dose chemotherapy and autologous hematopoietic stem cell transplant (HSCT) |
| Name | Type | Description |
|---|---|---|
| Tisagenlecleucel after optional bridging and lymphodepleting chemotherapy | DRUG | Investigator's choice of optional platinum-based immunochemotherapy (ie. R-ICE, R-GemOx, R-GDP, R-DHAP) + Lymphodepleting chemotherapy (fludarabine with cyclophosphamide or bendamustine) + Tisagenlecleucel (a second generation CAR-T composed of a CD19 antigen-binding domain, a 4-1BB costimulatory domain and a CD3-ζ signaling domain) |
| Platinum-based immunochemotherapy followed in responding patients with high dose chemotherapy and autologous hematopoietic stem cell transplant (HSCT) | DRUG | Investigator's choice of platinum-based immunochemotherapy (ie. R-ICE, R-GemOx, R-GDP, R-DHAP)+ High dose chemotherapy (ie. BEAM) + autologous HSCT. \*Ibrutinib or lenalidomide may be used in patients who are no longer eligible for autologous HSCT after 2 cycles of immunochemotherapy |
Inclusion Criteria: * Histologically confirmed, aggressive B-cell NHL at relapse/progression or PR after front line therapy. Aggressive B-cell NHL is heretofore defined by the following list of subtypes (Swerdlow et al 2016): * DLBCL, NOS, * FL grade 3B, * Primary mediastinal large B cell ly...
Tisagenlecleucel is a CD19-directed cell therapy being studied in adults with aggressive B-cell non-Hodgkin lymphoma. The Phase 3 program evaluated it in patients whose treatment followed optional bridging therapy and lymphodepleting chemotherapy. It is an investigational treatment for this indication, not a confirmed approved option based on the data described here.
Tisagenlecleucel targets CD19, a B-cell surface protein. It is classified as a binding agent and a cell therapy, meaning the therapeutic activity is directed at CD19-expressing cells. This CD19 targeting underlies its development in B-cell non-Hodgkin lymphoma, where the malignant cells typically express CD19.
Novartis AG, which trades under the ticker NVS, is the developer of tisagenlecleucel. The company is running the clinical program evaluating the therapy in adult patients with aggressive B-cell non-Hodgkin lymphoma, including the Phase 3 study NCT03570892.
Tisagenlecleucel is in Phase 3 development for non-Hodgkin lymphoma. The pivotal study, NCT03570892, is a completed Phase 3 trial. The therapy remains an investigational agent in this setting and is not described as FDA approved for this indication.
The Phase 3 trial NCT03570892, titled Tisagenlecleucel in Adult Patients With Aggressive B-cell Non-Hodgkin Lymphoma, enrolled 330 adults aged 18 and older. It was an active-controlled, randomized study that has completed. Sites spanned the United States, Europe, Asia, Australia, and South America, including China, Japan, and Brazil.
NCT03570892 was a randomized, active-controlled Phase 3 trial of tisagenlecleucel in 330 adults with aggressive B-cell non-Hodgkin lymphoma. Participants received optional bridging therapy followed by lymphodepleting chemotherapy before the cell therapy. The study was not double-blind, enrolled both sexes, and did not include healthy volunteers. It has completed.