12 Participants NeededMy employer runs this trial

Radiation + Antibody Therapy for Diffuse Large B-Cell Lymphoma

(REBEL Trial)

DS
AB
Overseen ByAllison Bock, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for diffuse large B-cell lymphoma, a type of blood cancer that has returned or resisted previous treatments. It combines a short course of external beam radiation therapy with a bispecific antibody treatment, which targets cancer cells. The trial aims to determine if this combination is safe and tolerable for patients. It may suit those who have tried at least two other treatments for this specific lymphoma and qualify for radiation therapy. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

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

The trial does not specify if you need to stop taking your current medications, but you cannot be on any other approved or investigational therapy for lymphoma, except for corticosteroids. 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?

Previous studies have shown that both epcoritamab and glofitamab are generally safe for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Research indicates these treatments effectively manage side effects, though some patients experienced cytokine release syndrome and fatigue. Epcoritamab has been used safely in outpatient settings, enhancing accessibility and potentially improving patients' quality of life. Glofitamab also maintains a manageable safety profile, even for patients with extensive treatment histories. This information suggests both treatments are well-tolerated, but patients should remain aware of possible side effects.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of radiation and bispecific antibody therapy for treating Diffuse Large B-Cell Lymphoma (DLBCL) because it introduces a novel approach to tackling this condition. Unlike traditional chemotherapy and monoclonal antibody treatments, this therapy uses bispecific antibodies like Epcoritamab or Glofitamab that can simultaneously bind to two different targets, potentially boosting the immune system's ability to attack cancer cells directly. Additionally, the integration of external beam radiation therapy over just five days may enhance the effectiveness of the antibody treatment by priming the cancer cells, making them more susceptible to immune attack. This approach could offer a new and potentially more effective treatment option for patients with DLBCL.

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

This trial will investigate the safety and tolerability of radiation therapy followed by bispecific antibody therapy with either Epcoritamab or Glofitamab for diffuse large B-cell lymphoma (DLBCL). Research has shown that both Epcoritamab and Glofitamab are promising treatments for relapsed or refractory DLBCL. Specifically, studies reported a 51% response rate to Epcoritamab, with 23% of patients achieving complete remission. Glofitamab showed a 53% response rate, with 30% achieving complete remission. Epcoritamab also reduced the risk of disease progression or death by 26% compared to chemotherapy. Additionally, Glofitamab improved outcomes, with a 27% complete remission rate in some real-world cases. These findings suggest that these treatments may effectively manage DLBCL symptoms for many patients.678910

Are You a Good Fit for This Trial?

This trial is for adults (18+) with diffuse large B-cell lymphoma that has come back or not responded after at least two treatments. Participants need to be healthy enough for radiation, have adequate blood counts and organ function, and must have at least two areas of disease.

Inclusion Criteria

My platelet count is at least 50,000, with or without transfusions.
My disease has come back or not responded after at least two treatments.
I am able to care for myself and do some daily activities.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive 5 days of radiation therapy

1 week

Bispecific Antibody Therapy

Participants receive bispecific antibody therapy (Epcoritamab or Glofitamab)

18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Epcoritamab
  • External Beam Radiation Therapy
  • Glofitamab

Trial Overview

The study tests the safety of giving targeted external beam radiation therapy first, followed by either epcoritamab or glofitamab (both are bispecific antibody drugs), in people with relapsed/refractory DLBCL.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Radiation followed by bispecific antibody therapyExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials
1,169
Recruited
1,623,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40663785/

Real-world outcomes of patients with aggressive B-cell ...

The overall response rate (ORR) for epcoritamab and glofitamab was 51% (23% complete response, [CR]) and 53% (30% CR), respectively. Median ...

Real-world outcomes of patients with aggressive B-cell ...

A total of 201 of 245 patients (82.0%) were efficacy-evaluable (124 treated with epcoritamab [80%], and 77 treated with glofitamab [87%]).

Glofitamab May Improve Outcomes in Patients With ...

Researchers determined glofitamab may induce a complete response rate in 27% of real-world cases of relapsed or refractory DLBCL.

Real-world efficacy outcomes of epcoritamab and ...

The majority (82%) had diffuse large B-cell lymphoma (DLBCL), followed by high-grade B-cell lymphoma (HGBCL, 14%), and others (5%). At BSAb ...

DLBCL Clinical Trial Results

61% of patients had a response (n=90/148; 95%. *Efficacy results determined by Lugano criteria (2014) as assessed by Independent Review Committee (IRC). † ...

Safety and efficacy of glofitamab for relapsed/refractory large ...

In summary, glofitamab demonstrates promising efficacy and a manageable safety profile in heavily pretreated patients with r/r DLBCL in a real-world scenario ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39661985/

Safety and efficacy of glofitamab for relapsed/refractory ...

The median progression-free survival (PFS) was 3.6 months, whereas the median overall survival was 5.7 months. Notably, 13 patients (19%) were ...

Real-world outcomes of patients with aggressive B-cell ...

The overall response rate (ORR) for epcoritamab and glofitamab was 51% (23% complete response, [CR]) and 53% (30% CR), respectively. Median ...

Outpatient Epcoritamab Demonstrates Efficacy and Safety ...

Epcoritamab shows promise for outpatient treatment of relapsed DLBCL, enhancing patient access and quality of life while managing side effects ...

OUTCOMES OF GLOFITAMAB AND EPCORITAMAB IN R ...

Our study suggests that bsAbs are an effective and safe treatment option for elderly DLBCL pts. Future efforts should focus on improving ...