EICHORCondition: Relapsed/Refractory Chronic Lymphocytic Leukemia · Small Lymphocytic Lymphoma · Richter's Syndrome · Sponsor: Genmab
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 vis…
This description comes directly from the study's public registry record.
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| O'Neal Comprehensive Cancer Center at University of Alabama at Birmingham | Birmingham, Alabama, United States | — |
| University of California Davis Medical Center Sacramento | California City, California, United States | — |
| City of Hope National Medical Center | Duarte, California, United States | — |
| Cedars-Sinai Medical Center | Los Angeles, California, United States | — |
| David Geffen School of Medicine | Los Angeles, California, United States | — |
| Stanford Cancer Center | Palo Alto, California, United States | — |
| Mount Sinai Comprehensive Cancer Center | Miami Beach, Florida, United States | — |
| Memorial Healthcare System | Pembroke Pines, Florida, United States | — |
| National Institutes of Health | Bethesda, Maryland, United States | — |
| Massachusetts General Hospital | Boston, Massachusetts, United States | — |
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan, United States | — |
| Henry Ford Medical Group | Detroit, Michigan, United States | — |
+ 69 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04623541