A Phase 2 Study of Epcoritamab-R-GemOx With Consolidative ASCT and Additional Epcoritamab in Relapsed/Refractory Transplant-Eligible DLBCL
City of Hope Medical Center
Summary
This phase II trial tests how well epcoritamab in combination with rituximab, gemcitabine and oxaliplatin (R-GemOx) works as treatment given after the cancer has not responded to other treatments (salvage therapy) before autologous stem cell transplant in treating patients with diffuse large B-cell lymphoma (DLBCL) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Epcoritamab is a so-called bispecific antibody, a molecule that can bind simultaneously to two different receptors (proteins present on the cell surface). Epcoritamab binds to a receptor called CD3 with one part of the antibody and to a receptor called CD20 with another part of the antibody. CD3 is expressed on T cells, which are important cells of the immune system that help the body fight cancers and infections. CD20 is expressed on the surface of DLBCL cells. By simultaneous binding to CD3 and CD20, epcoritamab brings T cells and DLBCL cells close together and activates the T cells to kill the lymphoma cells. Rituximab is a so-called monoclonal antibody, a molecule that binds to a single receptor. Like epcoritamab, rituximab binds to CD20. After binding to CD20, rituximab activates the immune system to kill the lymphoma cell through several different mechanisms. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill cancer cells. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill cancer cells. Giving epcoritamab-R-GemOx as therapy before an autologous stem cell transplant may help kill cancer cells in the body and help make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow.
Description
PRIMARY OBJECTIVE: I. Estimate the proportion of relapsed/refractory (r/r) transplant-eligible DLBCL patients who achieve complete response (CR) following epcoritamab + R-GemOx. SECONDARY OBJECTIVES: I. Estimate the overall response rate (ORR) of r/r transplant-eligible DLBCL patients following epcoritamab + R-GemOx. II. Estimate the proportion of r/r transplant-eligible DLBCL patients who successfully undergo autologous stem cell transplant (ASCT) following epcoritamab + R-GemOx, including rate of stem cell mobilization failure. III. Estimate progression-free survival (PFS), duration of…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative. * Assent, when appropriate, will be obtained per institutional guidelines * Agreement to allow the use of archival tissue from diagnostic tumor biopsies * If unavailable, exceptions may be granted with study principal investigator (PI) approval * Age: ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) ≤ 2 * Histologically confirmed diagnosis of DLBCL, not-otherwise specified (NOS), transformation of indolent B-cell lymphoma, High grade B-cell lymphoma (HGBCL), NOS, primary…
Interventions
- ProcedureAutologous Hematopoietic Stem Cell Transplantation
Undergo ASCT
- ProcedureBiopsy Procedure
Undergo tissue biopsy
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureBone Marrow Aspiration
Undergo bone marrow aspiration
- ProcedureBone Marrow Biopsy
Undergo bone marrow biopsy
- ProcedureComputed Tomography
Undergo CT
- BiologicalEpcoritamab
Locations (3)
- City of Hope Medical CenterDuarte, California
- City of Hope Atlanta Cancer CenterNewnan, Georgia
- City of Hope at ChicagoZion, Illinois