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

Conditions

• Adult Burkitt Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo collection of blood and CSF
• Bone Marrow Aspiration — PROCEDURE
  Undergo bone marrow biopsy/aspiration
• Bone Marrow Biopsy — PROCEDURE
  Undergo bone marrow biopsy/aspiration
• Computed Tomography — PROCEDURE
  Undergo PET/CT
• Cyclophosphamide — DRUG
  Given IV
• Doxorubicin — DRUG
  Given IV
• Echocardiography Test — PROCEDURE
  Undergo ECHO
• Epcoritamab — BIOLOGICAL
  Given SC
• Etoposide — DRUG
  Given IV
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Multigated Acquisition Scan — PROCEDURE
  Undergo MUGA
• Positron Emission Tomography — PROCEDURE
  Undergo PET/CT
• Prednisone — DRUG
  Given PO
• Rituximab — BIOLOGICAL
  Given IV
• Vincristine — DRUG
  Given IV

Study Details

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.

Key Dates

Start date

Sep 17, 2026

Status verified

Jun 2026

Primary completion

May 30, 2031

Completion

Apr 30, 2033

Study Design

Enrollment

43 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1 (epcoritamab, DA-EPOCH-R)
  Patients receive epcoritamab SC on days 1, 8, and 15 OR days 2, 9, and 16 OR days 3, 10, and 17 OR days 8 and 15 of cycle 1 at the determination of the investigators. Patients then receive epcoritamab SC on days 1, 8, and 15 of each cycle thereafter. Patients also receive DA-EPOCH-R consisting of etoposide, doxorubicin, and vincristine IV over 96 hours on days 1-4, prednisone or equivalent PO BID on days 1-5, cyclophosphamide IV over 1 hour on day 5, and rituximab IV on day 1 or days 1-2 of each cycle. Cycles repeat every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. NOTE: Patients who have received one cycle of DA-EPOCH or CHOP-like therapy off study receive only cycles 1-5). Patients also undergo MUGA or ECHO during screening, as well as PET/CT, and collection of blood and CSF throughout the study. Patients may also undergo bone marrow biopsy/aspiration during screening and MRI as clinically indicated.
• Active Comparator: Cohort 2 Arm I (DA-EPOCH-R)
  Patients receive DA-EPOCH-R as in Cohort 1 above. Patients also undergo MUGA or ECHO during screening, as well as PET/CT, and collection of blood and CSF throughout the study. Patients may also undergo bone marrow biopsy/aspiration during screening and MRI as clinically indicated.
• Experimental: Cohort 2 Arm II (epcoritamab, DA-EPOCH-R)
  Patients receive epcoritamab and DA-EPOCH-R as in Cohort 1 above. Patients also undergo MUGA or ECHO during screening, as well as PET/CT, and collection of blood and CSF throughout the study. Patients may also undergo bone marrow biopsy/aspiration during screening and MRI as clinically indicated.

Primary Outcome Measure

Proportion of participants who complete at least Cycle 3 among 10 participants (Feasibility) [ Time Frame: Up to 3 cycles (one cycles = 21 days) ]

Locations (1)

Find similar trials in New York, NY