Glofitamab as a Bridge to and/or Consolidation Post Autologous Stem Cell Transplant in Patients With Relapsed B Cell Lymphomas
brief summary
This is an investigator-initiated, open-label, single-arm, multicenter, Phase II clinical study. The study is designed to evaluate the safety and potential effectiveness of glofitamab in adults with their disease, diffuse large B-cell lymphoma (DLBCL has either not responded to initial treatment or has returned after an initial response and who are eligible and medically fit for autologous stem cell transplantation (ASCT). Autologous stem cell transplantation is a commonly used treatment in this situation and involves high-dose chemotherapy followed by infusion of your own stem cells, which are collected from your blood several weeks before the transplant. The purpose of this study is to assess glofitamab, which is not part of standard treatment. Glofitamab is a type of antibody designed to attach to both lymphoma cells and certain immune cells called T cells. By bringing these cells together, glofitamab may help activate the immune system so that T cells can better recognize and destroy lymphoma cells. In this study, glofitamab may be used as a "bridge" to transplantation and/or as consolidation treatment after the transplant, depending on how the disease responds to chemotherapy given before the transplant. In recent years, newer immune-based treatments such as CAR-T cell therapy have shown benefit for patients whose lymphoma does not respond to or returns after chemotherapy. CAR-T therapy involves collecting immune cells, modifying them in a laboratory, and then reinfusing them into the patient. However, access to CAR-T therapy is limited in some regions, including Lebanon, and autologous stem cell transplantation remains an important treatment option
detailed description
This is an investigator initiated open label, single arm, multicenter, phase II trial investigating the efficacy and safety of Glofitamab when used as a bridge to and/or consolidation post-transplant for patients with relapsed/refractory B-cell lymphomas (DLBCL or transformed low grade B cell lymphoma) fit and eligible for ASCT.
Primary Objective: To evaluate the efficacy of glofitamab when used as a bridge to and/or consolidation post-transplant for patients with relapsed/refractory B-cell lymphomas (DLBCL or transformed low grade B cell lymphoma) fit and eligible for ASCT ,
Secondary Objectives:
* To evaluate the efficacy of glofitamab when used as a bridge to and/or consolidation post-ASCT. * To evaluate the safety and tolerability of glofitamab in this setting * To evaluate the effect of glofitamab when used as a bridge to and/or consolidation post ASCT on health-related quality of life (HRQoL) Exploratory Objectives * To evaluate the effect of treatment with glofitamab on acute phase reactants such as fibrinogen and its clinical significance.
Adult patients (age 18-65) with primary refractory disease or relapsed CD20-positive DLBCL (all subtypes including primary mediastinal B cell lymphoma, high grade B cell lymphoma, large B cell lymphoma etc) or transformed low grade B-cell lymphoma, who are eligible for ASCT, planned to receive salvage therapy with Rituximab-chemotherapy regimens followed by ASCT.
official title
A Phase II,Open Label, Single Arm, Multicenter Study Investigating the Efficacy and Safety of Glofitamab When Used as a Bridge to and/or Consolidation Post-transplant for Patients With Relapsed/Refractory B-cell Lymphomas Transformed Low Grade B Cell Lymphoma) Fit and Eligible for ASCT