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 Objective:
(1) To assess the efficacy of Arm A1 (ER2 + E Maintenance) compared to Arm B (CIT + anti CD20 maintenance) in subjects with previously untreated FL.
Secondary Objectives
(1) Demonstrate that ER2 will improve OS compared to CIT in subjects with previously untreated FL in Arm A1 (ER2) versus Arm B (CIT).
(2) Demonstrate that ER2 will improve MRD negativity rate at C3D1/mid-induction compared to CIT in subjects with previously untreated FL in Arm A1 (ER2) versus Arm B (CIT).
(3) Demonstrate that subjects treated with ER2 will report higher Physical Functioning scores (using the Physical Functioning Scale of the EORTC-QLQ-C30) compared to CIT in subjects with
previously untreated FL in Arm A1 (ER2) at Week 21 versus Arm B (CIT) at Week 21/22.
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.