Epcoritamab in Combination With Dose Adjusted EPOCH-R for High-risk Burkitt Lymphoma (BL), The BEDROCK Study
3 other identifiers
interventional
43
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2026
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2026
CompletedFirst Posted
Study publicly available on registry
June 23, 2026
CompletedStudy Start
First participant enrolled
September 17, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2031
Study Completion
Last participant's last visit for all outcomes
April 30, 2033
June 23, 2026
June 1, 2026
4.7 years
June 17, 2026
June 17, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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.
Up to 3 cycles (one cycles = 21 days)
Overall survival
Kaplan-Meier method will be used to estimate survival rates for pre-specified time points along with 95% confidence intervals (CI).
From date of study registration and the date of death from any cause, assessed up to 2 years after completion of study treatment
Secondary Outcomes (10)
Progression-free survival
From date of study registration and the date of progression or the date of death from any cause, assessed up to 2 years after completion of study treatment
Incidence of dose-limiting toxicities
Up to 6 cycles (one cycles = 21 days)
Incidence of treatment-emergent adverse events
Up to 2 years after completion of study treatment
Overall response rate
Up to 2 years after completion of study treatment
Duration of response
From the date of documented response (CR or PR) and the date of progression or the date of death from any cause, assessed up to 2 years after completion of study treatment
- +5 more secondary outcomes
Study Arms (3)
Cohort 1 (epcoritamab, DA-EPOCH-R)
EXPERIMENTALPatients 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.
Cohort 2 Arm I (DA-EPOCH-R)
ACTIVE COMPARATORPatients 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.
Cohort 2 Arm II (epcoritamab, DA-EPOCH-R)
EXPERIMENTALPatients 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.
Interventions
Undergo collection of blood and CSF
Undergo bone marrow biopsy/aspiration
Undergo bone marrow biopsy/aspiration
Undergo PET/CT
Given IV
Given IV
Undergo ECHO
Given SC
Given IV
Undergo MRI
Undergo MUGA
Undergo PET/CT
Given PO
Given IV
Given IV
Eligibility Criteria
You may qualify if:
- 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
- +27 more criteria
You may not qualify if:
- Brain or spinal cord parenchymal disease
- Prior cytotoxic chemotherapy or radiotherapy for this lymphoma other than the following:
- 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)
- Participants with refractory HIV disease will not be eligible. Refractory HIV will be defined as prior ART exposure and HIV viral load \> 1000 copies/uL and no options for HIV control evaluated by HIV genotyping. Participants with HIV viral load \> 1000 copies/uL can be enrolled if additional ART will be initiated
- Any prior exposure to liposomal doxorubicin is allowed as long as the left ventricular ejection fraction (LVEF) is ≥ 45%. It is at the discretion of the investigator if prior exposure to doxorubicin for an unrelated malignancy is acceptable
- Participants with peripheral neuropathy Grade ≥ 3 or neuropathic pain Grade ≥ 2
- Participants with known brain metastases from solid tumors will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events (AEs)
- Participants with Hepatitis C (Hepatitis C antibody positive) with cirrhosis, whether Hepatitis C RNA level is measurable or not
- History of allergic reactions, hypersensitivity, or intolerance attributed to compounds of similar chemical or biologic composition to agents used in the study
- Participants must not have any condition that would make participation in this protocol unduly hazardous
- A pregnancy test must be performed within seven days prior to therapy administration in women of childbearing potential. Pregnant women are excluded from this study because the effects of epcoritamab on the developing human fetus are unknown. Because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with bispecific antibodies and chemotherapy, breastfeeding should be discontinued prior to treatment initiation and will not be permitted during treatment and for four months after the final treatment dose. Both male and female participants must use effective methods of birth control during the course of the study and for three months after stopping treatment. Participants must also agree to not donate eggs or sperm while taking the study drugs and for three months after stopping
- Unable to provide adequate informed consent in the opinion of the Principal Investigator (PI)
- Myocardial infarction within six months prior to study entry, New York Heart Association Class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AIDS Malignancy Consortiumlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ariela Noy
AIDS Malignancy Consortium
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2026
First Posted
June 23, 2026
Study Start (Estimated)
September 17, 2026
Primary Completion (Estimated)
May 30, 2031
Study Completion (Estimated)
April 30, 2033
Last Updated
June 23, 2026
Record last verified: 2026-06