A Phase 2 Study of Epcoritamab in Patients With Follicular Lymphoma Not Accomplishing a Complete Response With Upfront Chemoimmunotherapy
NCT Number: NCT06510361
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Lymphoma|Follicular Lymphoma|Lymphoma,Non-Hodgkin|Lymphoma, Non-Hodgkin's, Adult
Interventions: DRUG: Epcoritamab
Sponsor: Beth Israel Deaconess Medical Center
Collaborators: Genmab
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 35
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12
Completion Date: 2028-05-01
Locations: Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States

Summary:
This research is being done to see if epcoritamab is effective in treating follicular lymphoma as a second line of treatment.

The name of the study drug in this research study is:

-Epcoritamab (a type of antibody)

Primary Outcome Measures: Complete Response Rate (CRR), The CRR was defined as the proportion of participants achieving complete response (CR) based on Lugano Response Criteria (Adapted from Cheson, 2014)., CRR expected to be observed up to 12 months.
Secondary Outcome Measures: Overall Response Rate (ORR), The overall response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on Lugano Response Criteria (Adapted from Cheson, 2014)., ORR expected to be observed up to 12 months.|Median Progression-Free Survival (PFS), Progression-free survival based on the Kaplan-Meier method is defined as the duration between registration and documented disease progression (PD) or death, or is censored at time of last disease assessment., Survival collected during all visits through 24 months then every 6 months through 5 years.|Median Overall Survival (OS), Overall Survival (OS) based on the Kaplan-Meier method is defined as the time from study entry to death or censored at date last known alive., Survival observed up to 5 years|Median Time to Next Treatment (TTNT), TTNT estimated using the Kaplan Meier method is defined as the time from registration until date of initiation of next line of treatment., Up to 5 years|Median Duration of Response (DOR), DOR estimated using the Kaplan Meier method, is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) per Lugano Response Criteria, until the first date that recurrent or progressive disease is objectively documented. Participants without progressive disease are censored at the date of last disease assessment., Observation period up to approximately 12 cycles (1 cycle being 28 days)|Median Duration of Complete Response, Duration of complete response estimated using the Kaplan Meier method, is measured from the time measurement criteria are met for CR per Lugano Response Criteria, until the first date that recurrent or progressive disease is objectively documented. Participants without progressive disease are censored at the date of last disease assessment., Observation period up to approximately 12 cycles (1 cycle being 28 days)|Rate of Progression of Disease (PD) within 24 months (POD 24), The POD24 was defined as the proportion of participants achieving progression disease (PD) based on Lugano Response Criteria (Adapted from Cheson, 2014) within 24 months., Up to 24 months|Grade 4-5 Treatment-related Toxicity Rate, All grade 4-5 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv5 that are not resolved in accordance with treatment guidelines were counted. Rate is the proportion of treated participants experiencing at least one of these adverse events as defined during the time of observation., 12 months (12 cycles of treatment)|Rate of Disappearance of ctDNA, ctDNA assesment done using established method is the proportion of treated participants experiencing disappearance of ctDNA., 24 months