Epcoritamab in Combination With Dose Adjusted R-EPOCH for High Risk Burkitt Lymphoma (BL) (BEDROCK Study)
AIDS Malignancy Consortium
Summary
This phase II trial studies how well epcoritamab works in combination with the chemotherapy regimen dose adjusted etoposide, prednisone, Oncovin (vincristine), cyclophosphamide, hydroxydaunorubicin-rituximab (DA-EPOCH-R) in treating patients with high risk Burkitt lymphoma. Epcoritamab binds to a protein called CD3, which is found on T cells (a type of white blood cell). It also binds to a protein called CD20, which is found on B cells (another type of white blood cell) and some lymphoma cells. This may help the immune system kill cancer cells. Epcoritamab is a type of bispecific T-cell engager. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving epcoritamab in combination with the DA-EPOCH-R regimen may be an effective treatment for patients with high risk Burkitt lymphoma.
Description
PRIMARY OBJECTIVES: I. To demonstrate the feasibility of adding epcoritamab to dose adjusted etoposide, prednisone, Oncovin (vincristine), cyclophosphamide, hydroxydaunorubicin-rituximab (DA-EPOCH-R) in the first line treatment of high-risk Burkitt lymphoma (BL) patients with at least one adverse risk factor. (Cohort 1) II. To compare one-year overall survival (OS) of DA-EPOCH-R with or without epcoritamab in newly diagnosed high-risk BL with at least one additional high-risk feature. (Cohort 2) SECONDARY OBJECTIVES: I. To assess response rates and two-year OS. (Cohort 1 and 2) II. To asses…