CLINICAL TRIAL

Epcoritamab for Lymphoma, Large B-Cell, Diffuse

Grade III
Newly Diagnosed
Refractory
Relapsed
Recruiting · 18+ · All Sexes · Leuven, Belgium

This study is evaluating whether a drug called epcoritamab can be used to treat people with relapsed, refractory diffuse large B-Cell Lymphoma.

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About the trial for Lymphoma, Large B-Cell, Diffuse

Eligible Conditions
Lymphoma, Large B-Cell, Diffuse · Lymphoma, B-Cell · Lymphoma · Diffuse Large B-cell Lymphoma

Treatment Groups

This trial involves 2 different treatments. Epcoritamab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Epcoritamab
BIOLOGICAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Investigator's Choice Chemotherapy
DRUG

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Lymphoma, Large B-Cell, Diffuse or one of the other 3 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
You have DLBCL, including de novo or histologically transformed from FL. show original
Relapsed or refractory disease and previously treated with at least 1 line of systemic antineoplastic therapy including anti-CD20 mAb-containing combination chemotherapy since lymphoma diagnosis
DLBCL, NOS, including de novo or histologically transformed from FL
FL Grade 3B
T-cell/histiocyte-rich large B-cell lymphoma
ECOG PS score of 0-2
You are eligible for HDT-ASCT at screening. show original
You must have detectable disease by PET scan and measurable by CT scan or MRI. show original
Acceptable renal and liver function
You have a life expectancy of at least 2 months on SOC treatment. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: up to 2 years after randomization of the last patient
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years after randomization of the last patient
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: up to 2 years after randomization of the last patient.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Epcoritamab will improve 2 primary outcomes and 18 secondary outcomes in patients with Lymphoma, Large B-Cell, Diffuse. Measurement will happen over the course of throughout the study and up to 2 years following the last patient first dose.

Compare other measures of epcoritamab efficacy to SOC - Complete Response (CR)
THROUGHOUT THE STUDY AND UP TO 2 YEARS FOLLOWING THE LAST PATIENT FIRST DOSE
CR rate is calculated as the proportion of subjects achieving a complete response. Response is determined by the Lugano criteria and LYRIC.
THROUGHOUT THE STUDY AND UP TO 2 YEARS FOLLOWING THE LAST PATIENT FIRST DOSE
Compare other measures of epcoritamab efficacy to SOC - Progression Free Survival (PFS)
THROUGHOUT THE STUDY AND UP TO 2 YEARS FOLLOWING THE LAST PATIENT FIRST DOSE
PFS is calculated as the time from randomization to the date of disease progression or death, whichever is earlier. Progression is determined by the Lugano criteria and LYRIC.
THROUGHOUT THE STUDY AND UP TO 2 YEARS FOLLOWING THE LAST PATIENT FIRST DOSE
Compare other measures of epcoritamab efficacy to SOC - Time to Response (TTR)
THROUGHOUT THE STUDY AND UP TO 2 YEARS FOLLOWING THE LAST PATIENT FIRST DOSE
TTR is calculated as the time from randomization to date of initial response (CR or PR) among responders only. Response is determined by the Lugano criteria and LYRIC.
THROUGHOUT THE STUDY AND UP TO 2 YEARS FOLLOWING THE LAST PATIENT FIRST DOSE
Compare other measures of epcoritamab efficacy to SOC - Duration of Response (DOR)
THROUGHOUT THE STUDY AND UP TO 2 YEARS FOLLOWING THE LAST PATIENT FIRST DOSE
DOR is calculated as the time from initial response (CR or PR) to date of progression or death, whichever is earlier. Response and progression are determined by the Lugano criteria and LYRIC.
THROUGHOUT THE STUDY AND UP TO 2 YEARS FOLLOWING THE LAST PATIENT FIRST DOSE
Compare other measures of epcoritamab efficacy to SOC - Overall Response Rate (ORR)
THROUGHOUT THE STUDY AND UP TO 2 YEARS FOLLOWING THE LAST PATIENT FIRST DOSE
ORR is calculated as the proportion of subjects achieving a complete response or partial response. Response is determined by the Lugano criteria and LYRIC.
THROUGHOUT THE STUDY AND UP TO 2 YEARS FOLLOWING THE LAST PATIENT FIRST DOSE
Compare the clinical efficacy of epcoritamab to standard of care (SOC) - Overall Survival (OS)
THROUGHOUT THE STUDY AND UP TO 2 YEARS FOLLOWING THE LAST PATIENT FIRST DOSE
OS is calculated as the time from first dose to death date or last date known to be alive.
THROUGHOUT THE STUDY AND UP TO 2 YEARS FOLLOWING THE LAST PATIENT FIRST DOSE
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for lymphoma, large b-cell, diffuse?

Overall, the 5 year survival rate for DLBCL in Caucasian individuals, both primary and secondary, was 55.6%. Primary DLBCL is usually treated with chemotherapy followed with autologous transplantation in combination with CBT, while secondary DLBCL is rarely treated with systemic therapy. There was a 2.1 times greater chance of relapse in patients with secondary compared to primary DLBCL. Overall 5 year survival rate was 71.2%.

Anonymous Patient Answer

Can lymphoma, large b-cell, diffuse be cured?

LBL-D is a well-differentiated aggressive non-Hodgkin lymphoma. It is not curable by current treatment regimens, but the survival rate in this group of high-risk patients can be improved by intensified, high-intensity chemo-immunotherapy with CHOP and (if available) CHOP-R.

Anonymous Patient Answer

What are the signs of lymphoma, large b-cell, diffuse?

Lymphoproliferative disorders can present with non-B symptoms, particularly of an unexplained fever. They can be mistaken for other infections such as tuberculosis, and may mimic other systemic diseases such as a chronic or acute leukemia. We recommend that clinicians consider lymphoma in all unexplained fevers of immunocompromised patients.

Anonymous Patient Answer

What is lymphoma, large b-cell, diffuse?

Lymphoma, large b-cell, diffuse typically forms in two phases. The diagnosis and treatment of lymphoma, large b-cell, diffuse is challenging. Histopathologically, the pattern that is seen is predominantly of large cells (CD19 or CD20 positive) with little or no Bcl-2 expression. Treatment regimens used include a standard of care regimen and an active surveillance regimen.

Anonymous Patient Answer

What causes lymphoma, large b-cell, diffuse?

The major causal agents in the development of DLBCL, diffuse are the infections with Epstein-Barr virus in childhood, viral infections, leukemia (particularly lymphoblastic lymphoma), and/or immunologic deregulation.

Anonymous Patient Answer

How many people get lymphoma, large b-cell, diffuse a year in the United States?

Large B-cell, diffuse lymphoma makes up 8% to 12% of all cases of lymphoma annually in the USA. On average 3 cases per year were detected in women 30 years and older but accounted for 4% to 9% of lymphoma cases. The age-adjusted incidence of large B-cell, diffuse lymphoma in women and men is 2.0 and 4.4 cases per million annually, respectively. The age-adjusted incidence of large B-cell, diffuse lymphoma in blacks and whites in the USA is 15.3 and 13.0 in men and 15.8 and 10.3 in women per million annually.

Anonymous Patient Answer

Does epcoritamab improve quality of life for those with lymphoma, large b-cell, diffuse?

In a recent study, findings show that the addition of Epcoritamab to standard treatment is a promising treatment option for patients with large b-cell CD30-positive NHL with low to moderate peripheral neurotoxicity.

Anonymous Patient Answer

What is epcoritamab?

We demonstrate that epcoritamab, for the treatment of patients with relapsed/refractory DLBCL with low, or standard of care, response to prior therapy, is promising, at least in early on-treatment analysis, and this study supports early treatment of DLBCL with epcoritamab in the context of refractory disease.

Anonymous Patient Answer

What are the chances of developing lymphoma, large b-cell, diffuse?

Some patients with a previous diagnosis of lymphoma or [chronic lymphocytic leukemia](https://www.withpower.com/clinical-trials/chronic-lymphocytic-leukemia) may be at an increased risk for developing DLBCL, DLBCL, diffuse. Although the pathogenesis of these two conditions is not well understood, these diseases are thought to be the product of an activated, B-cell-dependent type of immune system (i.e., a highly activated immune response). Therefore, it is hypothesized that the predisposition to develop lymphoma or a leukemia is a consequence of the disease itself rather than a secondary phenomenon. A family history of DLBCL, DLBCL, diffuse and/or leukemia may be a marker for those patients who should be the subjects in clinical trials investigating immunomodulatory agents.

Anonymous Patient Answer

What are the latest developments in epcoritamab for therapeutic use?

Despite the limited numbers reported in this retrospective investigation, the preliminary results in this patient population suggest that epcoritamab achieves a better EFS than the comparator molidustin in this select patient group. This finding also suggests that epcoritamab, in terms of improved disease response rates, has maintained its potential as a promising therapeutic agent for DLBCL.

Anonymous Patient Answer

What does epcoritamab usually treat?

Clinically significant improvement observed in most patients with ALD may be due to other therapeutic actions or to the immune modulation by eculizumab. As additional clinical trials are underway, this question will be better understood.

Anonymous Patient Answer

What is the primary cause of lymphoma, large b-cell, diffuse?

To understand the cause of lymphoma, it is important to consider the lymphoproliferative diseases, which are lymphomas plus a disorder of the immune system. Primary lymphoma refers to lymphoma that has developed from the lymphoid tissue that surrounds most lymph glands. The lymphoid tissue consists of the white and red lymphoid cells that build up and fight infection. In most cases, these cells grow outside lymph nodes and invade tissues of tissues. These invade tissues often do not get the right amount of signals for cell survival and development into other cells that are needed for the immune system. Lymphopenia is the result of the decreased numbers of lymphoid cells and lymphocytes that can produce immune cells and fight off infection to survive.

Anonymous Patient Answer
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