Epcoritamab + Chemotherapy for Burkitt Lymphoma

Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: AIDS Malignancy Consortium
Must be taking: HAART
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

Why 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?

AN

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

I have been screened for hepatitis B and am receiving care if I have or had it.
I am 18 years old or older.
My heart condition is mild or I have no symptoms with ordinary activity.
See 22 more

Exclusion Criteria

I have cancer that has spread to my brain.
I am not taking certain HIV or strong CYP3A4 inhibitor medications, or I switched them a week ago.
Uncontrolled intercurrent illness or other significant conditions making participation unreasonably hazardous
See 17 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive epcoritamab and DA-EPOCH-R regimen for 6 cycles, each cycle lasting 21 days

18 weeks
Multiple visits per cycle for drug administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

2 years
Every 4 months

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

Group I: Cohort 2 Arm II (epcoritamab, DA-EPOCH-R)Experimental Treatment15 Interventions
Group II: Cohort 1 (epcoritamab, DA-EPOCH-R)Experimental Treatment15 Interventions
Group III: Cohort 2 Arm I (DA-EPOCH-R)Active Control14 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

AIDS Malignancy Consortium

Lead Sponsor

Trials
64
Recruited
9,600+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

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%.

Current 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 ...

Prognostic 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 ...

Genmab 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 ...

Phase 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.

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

Outpatient Epcoritamab Demonstrates Efficacy and Safety ...

Epcoritamab demonstrates safety and efficacy in outpatient settings for relapsed/refractory DLBCL, with manageable CRS and ICANS events.