Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Previously Untreated Follicular Lymphoma (EPCORE FL-2)
Categories (click each to see list of all clinical trials associated with that category): Lymphoma/CLL (ONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Bociek, R Gregory
Contact Information:
Susan Blumel, RN
402-559-9183
sblumel@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT06191744?term=NCT06191744&rank=1#participation-criteria
Summary
Primary
To assess the efficacy of ER2 compared to CIT in subjects with previously untreated FL.
Key Secondary
Key secondary objectives include the following:
Demonstrate that ER2 will improve PFS compared to CIT in subjects with previously untreated FL in Arm A (ER2) versus Arm B (CIT).
Demonstrate that ER2 will improve OS compared to CIT in subjects with previously untreated FL in Arm A (ER2) versus Arm B (CIT).
Demonstrate that ER2 will improve MRD negativity compared to CIT in subjects with previously untreated FL in Arm A (ER2) versus Arm B (CIT).
Demonstrate that ER2 will improve Maintenance of Physical Functioning (using the Physical Function Subscale of the EORTC-QLQ-C30) at Week 25 compared to CIT in subjects with previously untreated FL in Arm A (ER2) versus Arm B (CIT).
Safety Objectives
Safety evaluations include AE monitoring, physical examinations, vital sign measurements, ECG variables, and clinical laboratory testing (hematology, chemistry, and urinalysis) as measures of safety and tolerability for the entire study duration.