Epcoritamab in Combination With Dose Adjusted EPOCH-R for High-risk Burkitt Lymphoma (BL), The BEDROCK Study

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAIDS Malignancy Consortium

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Bone Marrow Aspiration
  • Bone Marrow Biopsy
  • Computed Tomography
  • Cyclophosphamide
  • Doxorubicin
  • Echocardiography Test
  • Epcoritamab
  • Etoposide
  • Magnetic Resonance Imaging
  • Multigated Acquisition Scan
  • Positron Emission Tomography
  • Prednisone
  • Rituximab
  • Vincristine

Treatment groups

43 Participants
are divided into 3 treatment groups

Sponsors and collaborators

AIDS Malignancy Consortium

Lead sponsor

National Cancer Institute (NCI)

Collaborator