Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome
Study Details
Protocol Summary
The study is a global, multi-center safety and efficacy trial of epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20). Epcoritamab will be tested either in
Relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) as:
- Monotherapy, or
- Combination therapy:
- epcoritamab + venetoclax
- epcoritamab + pirtobrutinib
In Non-United States (US) Participants Only: Treatment-naïve (TN) high risk (HR) (CLL):
• epcoritamab + pirtobrutinib
Combination therapy for Richter's Syndrome (RS):
- epcoritamab + lenalidomide
- epcoritamab + R-CHOP (i.e., rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine \[Oncovin®\] and prednisone).
The study includes participants with R/R or TN HR CLL (non-US participants only)/small lymphocytic lymphoma (SLL) and participants with RS.
The trial consists of two parts, a dose-escalation phase (phase Ib) and an expansion phase (phase II). Participants with RS are only included in the expansion phase.
Epcoritamab will be injected subcutaneously (under the skin). Standard-of-care and combination treatments (venetoclax, pirtobrutinib, lenalidomide, and R-CHOP) will be given either orally (by mouth) or intravenously (in a vein).
Study details include:
- Study duration will be up to 5 years after the last participant's first treatment in the trial.
- The treatment duration for each participant will be between 12 months (1 year) and 24 months (2 years), depending upon the treatment arm assigned.
- The visit frequency will be either weekly, every other week, or monthly, depending upon the part of the study.
All participants will receive active drug; no one will be given placebo.