Epcoritamab Plus Ibrutinib for the Treatment of Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphoma
NCT Number: NCT06536049
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Recurrent Diffuse Large B-Cell Lymphoma|Recurrent Grade 3b Follicular Lymphoma|Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements|Recurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements|Recurrent High Grade B-Cell Lymphoma, Not Otherwise Specified|Recurrent Primary Mediastinal Large B-Cell Lymphoma|Recurrent Transformed Non-Hodgkin Lymphoma|Refractory Diffuse Large B-Cell Lymphoma|Refractory Grade 3b Follicular Lymphoma|Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements|Refractory High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements|Refractory High Grade B-Cell Lymphoma, Not Otherwise Specified|Refractory Primary Mediastinal Large B-Cell Lymphoma|Refractory Transformed Non-Hodgkin Lymphoma
Interventions: PROCEDURE: Biospecimen Collection|PROCEDURE: Bone Marrow Aspiration|PROCEDURE: Bone Marrow Biopsy|PROCEDURE: Computed Tomography|BIOLOGICAL: Epcoritamab|DRUG: Ibrutinib|PROCEDURE: Positron Emission Tomography
Sponsor: Yazeed Sawalha
Collaborators: AbbVie|Genmab
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 38
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-31
Completion Date: 2026-12-31
Locations: University of Minnesota/Masonic Cancer Center, Minneapolis, Minnesota, 55455, United States|Ohio State University Comprehensive Cancer Center, Columbus, Ohio, 43210, United States

Summary:
This phase Ib/II trial evaluates the safety, optimal dose, and efficacy of the combination of epcoritamab and ibrutinib in treating patients with aggressive B-cell non-Hodgkin lymphoma that has come back (relapsed) or responded to previous treatment (refractory). Epcoritamab, a bispecific antibody, binds to two different types of receptors (proteins present on the cell surface) at the same time. The two receptors that epcoritamab binds to are called CD3 and CD20. CD3 is found on T cells, which are important cells of the immune system that help fight cancer and infections. CD20 is found on the surface of most types of aggressive B-cell non-Hodgkin lymphoma cells. By binding to both CD3 and CD20, epcoritamab brings the two cells close together so the T cells can fight and kill the lymphoma B cells. Ibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, binds to a protein on B cells, a type of white blood cell from which the lymphoma developed. By doing this it decreases the ability of the lymphoma B cells to survive and grow. Ibrutinib may also improve the health (or fitness) of T cells thus making epcoritamab safer and/or more effective.

Primary Outcome Measures: Incidence of adverse events (AEs), AEs will be tabulated by type and grade using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 and displayed in summary form. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns., Up to 60 days after last dose of study drug|Incidence of cytokine release syndrome (CRS), CRS severity will be graded using American Society for Transplantation and Cellular Therapy Cytokine Release Syndrome criteria. The CRS rate will be calculated together with 95% one-sided confidence intervals among evaluable patients., Up to 60 days after last dose of study drug
Secondary Outcome Measures: Overall response rate (ORR), ORR will be defined as the proportion of patients achieving a complete or partial response and reported with a 95% binomial confidence interval., Up to 24 months|Complete response (CR) rate, Up to cycle 12 (each cycle is 28 days)|Progression-free survival (PFS), PFS will be defined for all patients who begin treatment therapy to the date of progression or death. PFS will be estimated using the method of Kaplan-Meier, where estimates at time points of interest will be reported with 95% confidence intervals. Median PFS will be evaluated if estimable., From the start of treatment to the time of progression or death, whichever occurs first, assessed up to 5 years|Duration of response (DOR), Up to 5 years|Overall survival (OS), OS will be defined for all patients who begin treatment therapy to the date of death from any cause. OS will be estimated using the method of Kaplan-Meier, where estimates at time points of interest will be reported with 95% confidence intervals. Median OS will be evaluated if estimable., From the start of treatment to death from any cause, assessed up to 5 years