A Phase 2 Study of Outpatient Epcoritamab in Large B-cell Lymphoma
Massachusetts General Hospital
Summary
The purpose of this study is to measure the efficacy of the study drug, epcoritamab, in participants with relapsed/refractory large B-cell lymphoma.
Description
This is a phase 2 study of outpatient administration of administration of epcoritamab in large B-cell lymphoma. The first line cohort will enroll participants with treatment-naïve large B-cell lymphoma who are "frail" and/or medically "unfit" on a standardized assessment. The second line cohort will enroll non-transplant eligible large B-cell lymphoma that has relapsed after, or is refractory to, 1 prior line of therapy. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: First Line Cohort * No prior systemic antineoplastic therapy for large B-cell lymphoma. * Score of "frail" or "unfit" on Fondazione Italiana Linfomi simplified Geriatric Assessment (FIL sGA) (Appendix E). Second Line Cohort * Relapsed or refractory disease treated with 1 prior systemic antineoplastic line of therapy that includes an anti-CD20 monoclonal antibody plus an anthracycline and/or an alkylating agent. Patients who have received more than 1 prior systemic antineoplastic line of therapy are not eligible. * Not a candidate for high dose chemotherapy and autologou…
Interventions
- DrugEpcoritamab
Bispecific IgG1 antibody
- DrugRituximab combined with cyclophosphamide, vincristine, and prednisone
Epco-R-CVP
- DrugRituximab combined with cyclophosphamide, doxorubicin, vincristine, and prednisone
Epco-R-CHOP
- DrugRituximab combined with polatuzumab, cyclophosphamide, doxorubicin, and prednisone
Epco-pola-R-CHP
Locations (2)
- Massachusetts General HospitalBoston, Massachusetts
- Newton-Wellesley HospitalNewton, Massachusetts