Epcoritamab + Chemotherapy for Burkitt Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new combination of treatments for individuals with high-risk Burkitt lymphoma, a fast-growing cancer. It combines epcoritamab, which aids the immune system in attacking cancer cells, with a chemotherapy regimen known as DA-EPOCH-R. The trial aims to determine if this combination is more effective at treating the cancer than chemotherapy alone. Individuals with Burkitt lymphoma and certain high-risk factors, such as large tumors or cancer in the bone marrow, might be suitable candidates for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants, offering a chance to benefit from potentially more effective therapy.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that epcoritamab is generally safe for patients. Studies involving those with relapsed or refractory diffuse large B-cell lymphoma (a type of blood cancer) indicate it is usually well-tolerated. Most side effects, such as cytokine release syndrome (a reaction where the immune system releases too many proteins into the blood too quickly) and neurological events, are mild and manageable.
The chemotherapy treatment DA-EPOCH-R, which includes drugs like vincristine and doxorubicin, has a well-documented safety record. Patients often experience side effects like tiredness, nausea, and reduced blood cell counts, but these are expected and can usually be managed with medical help.
Overall, previous research has shown that combining epcoritamab with DA-EPOCH-R offers a promising safety profile. It is important for patients to discuss potential side effects with healthcare providers to fully understand them.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they include epcoritamab, a novel antibody therapy that targets and kills cancer cells in Burkitt Lymphoma. Unlike standard treatments like R-CHOP, which rely solely on chemotherapy and rituximab, epcoritamab offers a new mechanism by specifically engaging the immune system to attack the cancer cells. Additionally, epcoritamab is administered subcutaneously, which can be more convenient and potentially less taxing on the patient compared to traditional intravenous methods. This combination of targeted action and easier administration makes it a promising addition to existing therapies.
What evidence suggests that this trial's treatments could be effective for high risk Burkitt lymphoma?
Research has shown that epcoritamab, when combined with chemotherapy, yields promising results for treating high-risk Burkitt lymphoma. In this trial, participants in Cohort 1 and Cohort 2 Arm II will receive the combination of epcoritamab and DA-EPOCH-R chemotherapy. Earlier studies of this combination treatment reported an overall response rate of 87%, with 65% of patients experiencing a complete response, meaning their cancer disappeared. Epcoritamab attaches to certain proteins on white blood cells, aiding the immune system in identifying and destroying cancer cells. This suggests that epcoritamab could be a valuable addition to the usual chemotherapy treatment for this aggressive type of lymphoma.46789
Who Is on the Research Team?
Ariela Noy
Principal Investigator
AIDS Malignancy Consortium
Are You a Good Fit for This Trial?
This trial is for people with high-risk Burkitt lymphoma or Burkitt leukemia. Participants should be able to undergo intensive chemotherapy and related tests. The study may exclude those with certain health conditions, but specific inclusion/exclusion details are not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive epcoritamab and DA-EPOCH-R regimen for 6 cycles, each cycle lasting 21 days
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
What Are the Treatments Tested in This Trial?
Interventions
- Cyclophosphamide
- Doxorubicin
- Epcoritamab
- Etoposide
- Prednisone
- Rituximab
- Vincristine
Trial Overview
The trial is testing epcoritamab (an immune therapy) combined with a strong chemotherapy regimen called DA-EPOCH-R (which includes etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab) to see if this combination works well against high-risk Burkitt lymphoma.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
AIDS Malignancy Consortium
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
Genmab announces trial outcomes of epcoritamab combo
The combo therapy demonstrated an ORR of 87%, with a complete response rate of 65% and a partial response rate of 23%.
2.
cancernetwork.com
cancernetwork.com/view/journal-current-treatment-of-burkitt-lymphoma-and-high-grade-b-cell-lymphomasCurrent Treatment of Burkitt Lymphoma and High-Grade B- ...
demonstrated a 3-year OS rate of 49%, improved outcomes, including a 3-year EFS rate of 80% and 3-year OS rate of 89%. median survival of ...
DLBCL Clinical Trial Results
EPKINLY delivered an ORR of 61%, with 38% of patients achieving a deep response of CR1 61% of patients had a response. The median follow-up for DOR was 9.8 ...
4.
ashpublications.org
ashpublications.org/bloodadvances/article/10/16/5496/568886/Prognostic-factors-and-survival-outcomes-inPrognostic factors and survival outcomes in relapsed ...
The best overall response rate (ORR) was 49.6%, and the best complete response rate (CRR) was 31.9%. Outcomes remain poor for patients with LBCLs and other ...
5.
ir.genmab.com
ir.genmab.com/news-releases/news-release-details/genmab-announces-epcoritamab-monotherapy-and-epcoritamab-basedGenmab Announces Epcoritamab Monotherapy and ...
Results from the Phase 2 EPCORE® DLBCL-3 study showed an overall response rate (ORR) of 67% and a complete response (CR) rate of 58% with ...
6.
ashpublications.org
ashpublications.org/blood/article/140/Supplement%201/3827/492526/Phase-1b-Trial-of-Subcutaneous-Epcoritamab-inPhase 1b Trial of Subcutaneous Epcoritamab in Pediatric ...
Because favorable safety and efficacy data were observed in adults, it is reasonable to investigate use of epcoritamab in children with R/R MBL ...
NCT07662928 | Epcoritamab in Combination With Dose ...
Giving epcoritamab in combination with the DA-EPOCH-R regimen may be an effective treatment for patients with high risk Burkitt lymphoma.
8.
clinicaltrials.eu
clinicaltrials.eu/trial/study-on-the-safety-of-epcoritamab-for-children-and-young-adults-with-relapsed-or-refractory-aggressive-b-cell-lymphomas/Study on the Safety of Epcoritamab for Children and Young ...
The purpose of the study is to evaluate the safety and how the body processes Epcoritamab in children and young adults
9.
targetedonc.com
targetedonc.com/view/outpatient-epcoritamab-demonstrates-efficacy-and-safety-in-r-r-dlbclOutpatient Epcoritamab Demonstrates Efficacy and Safety ...
Epcoritamab demonstrates safety and efficacy in outpatient settings for relapsed/refractory DLBCL, with manageable CRS and ICANS events.
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