Epcoritamab in Combination With Dose Adjusted EPOCH-R for High-risk Burkitt Lymphoma (BL), The BE… (NCT07662928) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Epcoritamab in Combination With Dose Adjusted EPOCH-R for High-risk Burkitt Lymphoma (BL), The BEDROCK Study
United States43 participantsStarted 2026-09-17
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* High-risk adult BL patients, as defined by:
* Stage I with any ONE of the following:
* A single lesion 10 cm or greater
* Elevated lactate dehydrogenase (LDH)
* Total resection of intra-abdominal disease with an elevated LDH after surgery OR
* Stage II or higher
* Either of the above PLUS ANY one of the following additional risk factors:
* Involvement of the bone marrow
* Involvement by the peripheral blood by morphology or flow cytometry
* Presence of leptomeningeal disease
* Age ≥ 40 years
* Lactate dehydrogenase \> 3× upper limit of normal (ULN)
* Eastern Cooperative Oncology Group (ECOG) performance status 2-3
* Treatment naive or one prior cycle of chemotherapy whether anthracycline based or not
* If HIV positive and had an opportunistic infection within three months, participant must be recovered and willing to take prophylaxis as clinically indicated
* If HIV positive, any CD4 count is acceptable
* A minimum of two HIV-positive participants will be enrolled in Cohort 1 and a minimum of 10 HIV-positive participants will be enrolled in the randomized cohort. Once 18 HIV-negative participants are enrolled, future enrollment will allow only HIV-positive participants
* Known HIV status. Participants may be HIV posi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of participants who complete at least Cycle 3 among 10 participants (Feasibility)
Timeframe: Up to 3 cycles (one cycles = 21 days)
2
Overall survival
Timeframe: From date of study registration and the date of death from any cause, assessed up to 2 years after completion of study treatment