Radiation + Antibody Therapy for Diffuse Large B-Cell Lymphoma
(REBEL Trial)
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Radiation
Participants receive 5 days of radiation therapy
Bispecific Antibody Therapy
Participants receive bispecific antibody therapy (Epcoritamab or Glofitamab)
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
This study will investigate the safety and tolerability of 5 days of radiation therapy followed directly by a bispecific antibody therapy (Epcoritamab or Glofitamab).
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Utah
Lead Sponsor
Citations
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 ...
2.
ashpublications.org
ashpublications.org/blood/article/146/18/2177/546196/Real-world-outcomes-of-patients-with-aggressive-BReal-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%]).
3.
hematologyadvisor.com
hematologyadvisor.com/news/glofitamab-lymphoma-dlbcl-improve-outcomes-treatment-risk/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). † ...
6.
ashpublications.org
ashpublications.org/bloodadvances/article/9/15/3865/534578/Safety-and-efficacy-of-glofitamab-for-relapsedSafety 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 ...
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 ...
9.
targetedonc.com
targetedonc.com/view/outpatient-epcoritamab-demonstrates-efficacy-and-safety-in-r-r-dlbclOutpatient 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 ...
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