Epcoritamab + R-GemOx for Diffuse Large B-Cell Lymphoma

Not yet recruiting at 2 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: City of Hope Medical Center
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 treatment for individuals with diffuse large B-cell lymphoma (DLBCL) that has returned or resisted previous treatments. The treatment combines epcoritamab, a drug that helps the immune system attack cancer, with three other drugs commonly used for this lymphoma type: gemcitabine, oxaliplatin, and rituximab. The researchers aim to determine if this combination can better prepare patients for a stem cell transplant by reducing their cancer. This trial may suit those whose DLBCL has recurred or remains difficult to treat after at least one round of chemoimmunotherapy. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, it does mention that active medications known to decrease T-cell numbers or activity, or other immunosuppressive medications, should not be used within a certain period before starting the trial. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining epcoritamab with gemcitabine and oxaliplatin is generally safe and well-tolerated by patients with diffuse large B-cell lymphoma (DLBCL). Studies indicate that many patients experience tumor reduction or remission with this treatment, which is also linked to longer survival times. Although all treatments can have side effects, evidence suggests that most patients can manage this combination. Patients should always discuss potential side effects and concerns with their healthcare provider.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about Epcoritamab combined with R-GemOx for treating Diffuse Large B-Cell Lymphoma because it introduces a novel approach compared to traditional treatments like R-CHOP. Epcoritamab is a bispecific antibody, meaning it can simultaneously engage both the cancer cells and the immune system, potentially enhancing the body's ability to fight the cancer. Additionally, Epcoritamab is administered subcutaneously, which might offer a more convenient and less invasive option compared to intravenous treatments. This combination aims to optimize both attack on the cancer and patient comfort, offering new hope for those with this challenging condition.

What evidence suggests that this trial's treatments could be effective for diffuse large B-cell lymphoma?

Research has shown that combining epcoritamab with gemcitabine and oxaliplatin (Epcor+GemOx) may effectively treat diffuse large B-cell lymphoma (DLBCL) that is difficult to manage. In this trial, participants will receive Epcor+GemOx, which previous studies have found to improve response rates and survival outcomes compared to the usual treatment with rituximab, gemcitabine, and oxaliplatin (R-GemOx). Epcoritamab is a special type of antibody that helps the immune system target and destroy cancer cells. Gemcitabine and oxaliplatin are chemotherapy drugs that damage the DNA of cancer cells. This combination might benefit patients whose cancer has returned or hasn't responded to other treatments.12356

Who Is on the Research Team?

GS

Geoffrey Shouse

Principal Investigator

City of Hope Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with relapsed/refractory diffuse large B-cell lymphoma who haven't had CAR-T cell therapy. They must be able to provide a tissue sample, have an ECOG performance status of ≤2 (able to carry out light activity), and give informed consent.

Inclusion Criteria

I have never received CAR T-cell therapy.
I have given my informed consent to participate.
I have given my consent following the rules of the healthcare facility.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Salvage Therapy

Patients receive epcoritamab subcutaneously on day 8 of cycle 1 and days 1 and 8 of subsequent cycles and R-GemOx on day 1 of each cycle. Cycles repeat every 14 days for up to 3 cycles.

6 weeks
3 visits (in-person)

Autologous Stem Cell Transplant (ASCT)

Patients undergo autologous stem cell transplant.

Consolidation

Patients receive epcoritamab subcutaneously on days 1, 8, and 15 of cycle 1 and on days 1 and 15 of subsequent cycles. Cycles repeat every 28 days for up to 6 cycles.

24 weeks
6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months
Follow-up at 30 and 60 days, then at 12 and 24 months

What Are the Treatments Tested in This Trial?

Interventions

  • Epcoritamab
  • Gemcitabine
  • Oxaliplatin
  • Rituximab

Trial Overview

The trial tests epcoritamab combined with rituximab, gemcitabine, and oxaliplatin (R-GemOx) as salvage therapy before autologous stem cell transplant in patients whose DLBCL has returned or resisted treatment. It aims to activate the immune system to kill cancer cells.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Treatment (Epcoritamab-R-GemOx)Experimental Treatment11 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials
614
Recruited
1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

Epcoritamab Plus Gemcitabine and Oxaliplatin Versus ...

The rituximab plus gemcitabine and oxaliplatin (R-GemOx) regimen has been a widely used treatment for patients with R/R DLBCL ineligible for ...

Epcoritamab Plus Gemcitabine and Oxaliplatin Versus ...

This indirect treatment comparison evaluated epcoritamab plus gemcitabine and oxaliplatin (Epcor+GemOx) versus rituximab (R)-GemOx in patients ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41206325/

Epcoritamab Plus Gemcitabine and Oxaliplatin Versus ...

Epcor+GemOx provides significantly greater response rates and survival outcomes compared with R-GemOx in patients with transplant-ineligible R/R DLBCL.

Epcoritamab, Rituximab, Gemcitabine and Oxaliplatin (R ...

This phase II trial tests how well epcoritamab in combination with rituximab, gemcitabine and oxaliplatin (R-GemOx) works as treatment given ...

Updated results from EPCORE NHL-2.

We report additional efficacy and safety results of epcoritamab + GemOx in difficult-to-treat R/R DLBCL (EPCORE™ NHL-2 phase 1/2 trial, NCT04663347). Methods: ...

AbbVie Announces Topline Results for Epcoritamab ...

EPCORE DLBCL-1 (NCT04628494) is a global Phase 3 open label, multi-center, randomized trial to evaluate the efficacy of epcoritamab (GEN3013, ...