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.
Histologically and immunophenotypically (via at least a core or ideally, incisional or excisional biopsy) documented BL at the treating institution. All stages of BL are eligible
A single lesion 10 cm or greater
Elevated lactate dehydrogenase (LDH)
Total resection of intra-abdominal disease with an elevated LDH after surgery OR
Brain or spinal cord parenchymal disease
Palliative radiation for medical emergencies (like cord compression)
A maximum of one cycle of combination chemotherapy, including EPOCH or cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP)-like therapy. The start of the previous chemotherapy cycle must occur at least 21 days but no more than four weeks prior to the beginning of therapy under this protocol, and such cycle will count towards the maximum of six cycles under this study (i.e., cycle off study will count as Cycle 1).
One prior cycle of limited therapy including cyclophosphamide and/or glucocorticoids to improve performance status or hepatic or renal function impaired due to lymphoma involvement. The start of this therapy may occur up to four weeks prior to the beginning of study treatment under this protocol. Cyclophosphamide administration must have been completed at least 14 days prior to initiation of study treatment. Such treatment will not count towards the maximum of six cycles under this study (i.e., participants will receive six cycles on study)
Sequential
Biospecimen Collection
Procedure/SurgeryUndergo collection of blood and CSF
Bone Marrow Aspiration
Procedure/SurgeryUndergo bone marrow biopsy/aspiration
Bone Marrow Biopsy
Procedure/SurgeryUndergo bone marrow biopsy/aspiration
Computed Tomography
Procedure/SurgeryUndergo PET/CT
Cyclophosphamide
DrugGiven IV
Doxorubicin
DrugGiven IV
Echocardiography Test
Procedure/SurgeryUndergo ECHO
Epcoritamab
Biological/VaccineGiven SC
Etoposide
DrugGiven IV
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Multigated Acquisition Scan
Procedure/SurgeryUndergo MUGA
Positron Emission Tomography
Procedure/SurgeryUndergo PET/CT
Prednisone
DrugGiven PO
Rituximab
Biological/VaccineGiven IV
Vincristine
DrugGiven IV
Proportion of participants who complete at least Cycle 3 among 10 participants (Feasibility)
A cycle with at least one dose of epcoritamab 48 mg will be considered complete.
Overall survival
Kaplan-Meier method will be used to estimate survival rates for pre-specified time points along with 95% confidence intervals (CI).
Progression-free survival
Kaplan-Meier method will be used to estimate survival rates for pre-specified time points along with 95% CI.
Incidence of dose-limiting toxicities
Will be based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Safety analysis will include detailed tabulations of adverse events (AEs) by type, grade, and treatment attribution.
Incidence of treatment-emergent adverse events
Will be based on NCI CTCAE version 5.0. Safety analysis will include detailed tabulations of AEs by type, grade, and treatment attribution.
Overall response rate
Defined as proportion of participants with complete response (CR) or partial response (PR). Responses will be assessed by Lugano criteria. Will be estimated along with corresponding 95% CI using Fisher's exact method.
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AIDS Malignancy Consortium
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Memorial Sloan Kettering Cancer Center
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
