Epcoritamab, Zanubrutinib, and Rituximab (EZR) for R/R FL Relapsed or Refractory Follicular Lymphoma
NCT Number: NCT06563596
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Follicular Lymphoma|Lymphoma|Non-Hodgkin Lymphoma|Relapsed Lymphoma|Refractory Lymphoma
Interventions: DRUG: Zanubrutinib|DRUG: Rituximab|DRUG: Epcoritamab
Sponsor: Reid Merryman, MD
Collaborators: BeiGene|Genmab
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-02
Completion Date: 2029-03-01
Locations: Brigham and Women's Hospital, Boston, Massachusetts, 02215, United States|Dana-Farber Cancer Institute, Boston, Massachusetts, 02215, United States

Summary:
The purpose of this study is to determine how effective and safe the combination of epcoritamab, zanubrutinib, and rituximab is in treating participants with relapse or refractory Follicular Lymphoma (FL).

* The names of the study drugs involved in this research study are:
* Epcoritamab (a type of antibody)
* Zanubrutinib (a type of Bruton tyrosine kinase inhibitor)
* Rituximab (a type of monoclonal antibody)

Primary Outcome Measures: Complete Metabolic Response (CMR) Rate, CMR rate is defined as the proportion of participants who achieved CMR during study. CMR assessed by PET/CT is defined using Lugano criteria., 6 months
Secondary Outcome Measures: Objective Response Rate (ORR), ORR is defined as the participants who achieved complete response (CR) and partial response (PR) during study. Response is defined using Lugano criteria., 24 months|Partial Response Rate (PRR), PRR is defined as the participants who achieved partial response during study. Response is defined using Lugano criteria., 24 months|End-of-treatment Objective Response Rate (EOT ORR), EOT ORR is defined as the proportion of participants who achieved complete response (CR) or partial response (PR) at the end of treatment visit. Response is assessed by PET/CT using Lugano criteria., Up to 24 months - End-of treatment visit occurs 4 weeks after cycle 24 day 1. Each cycle is 4 weeks. Participants who discontinue therapy due to toxicity would also undergo an EOT evaluation approximately 4 weeks after the last dose of study treatment.|End-of-treatment Partial Response Rate (EOT PRR), EOT PRR is defined as the proportion of participants who achieved partial response (PR) at the end of treatment visit. Response is assessed by PET/CT using Lugano criteria., Up to 24 months - End-of treatment visit occurs 4 weeks after cycle 24 day 1. Each cycle is 4 weeks. Participants who discontinue therapy due to toxicity would also undergo an EOT evaluation approximately 4 weeks after the last dose of study treatment.|End-of-treatment Complete Response Rate (EOT CRR), EOT CRR is defined as the proportion of participants who achieved complete response (CR) at the end of treatment visit. Response is assessed by PET/CT using Lugano criteria., Up to 24 months - End-of treatment visit occurs 4 weeks after cycle 24 day 1. Each cycle is 4 weeks. Participants who discontinue therapy due to toxicity would also undergo an EOT evaluation approximately 4 weeks after the last dose of study treatment.|Duration of Response (DOR), The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started, or death due to any cause). Participants without events reported are censored at the last disease evaluation., 5 years|Duration of Complete Response (DOCR), The duration of overall CR is measured from the time measurement criteria are first met for CR until the first date that progressive disease is objectively documented, or death due to any cause. Participants without events reported are censored at the last disease evaluation., 5 years|2-Year Progression Free Survival (PFS2), 2-year PFS is the percent probability estimate at 2 years based on the Kaplan-Meier method. PFS is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Participants alive without PD are censored at the earliest of the date of the last disease evaluation or start of new anti-cancer therapy., 2 years|Median Progression Free Survival, PFS based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Participants alive without PD are censored at the earliest of the date of the last disease evaluation or start of new anti-cancer therapy., 5 years|Median Time-to-next treatment (TTNT), Time to next treatment (TTNT) based on Kaplan-Meier methodology will be calculated as time from the start of treatment to the date of initiation of the next line of treatment. Participants who have not progressed to a subsequent line of therapy, will be censored at the date of last follow up or at death., 5 years|Median Overall Survival (OS), OS based on Kaplan-Meier methodology is defined as the time from registration to death due to any cause, or censored at date last known alive., 12 years|Incidence of Histological Transformation, Incidence of Histological Transformation (HT) based on Kaplan-Meier methodology defined as as the number of cases of HT divided by the total number of individuals in the population at risk at that specific time interval., 5 years|Cytokine Release Syndrome (CRS) Rate, CRS Rate is defined as the proportion of participants who experience CRS. CRS is graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) grading., 24 months|Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS) Rate, ICANS Rate is defined as the proportion of participants who experienced ICANS during the study. ICANS graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) grading., 24 months|Rate of Grade 3 or Higher Toxicity Regardless of Attribution, The percentage of participants who experience a maximum grade 3 or higher adverse event based on the Common Toxicity Criteria for Adverse events Version 5.0 (CTCAEv5) as reported on case report forms., 24 months|Rate of Grade 2 or Higher Toxicity at Least Possibly Related to Study Treatment, The percentage of participants who experience a maximum grade 2 or higher at least possibly related to study treatment adverse event based on the Common Toxicity Criteria for Adverse events Version 5.0 (CTCAEv5) as reported on case report forms., 24 months