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Alkylating agents

Epcoritamab + R-CHOP for Diffuse Large B-Cell Lymphoma (EPCORE DLBCL-2 Trial)

Phase 3
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has at least one target lesion defined as: >= 1 measurable nodal lesion (long axis > 1.5 cm ) or >= 1 measurable extra-nodal lesion (long axis > 1 cm) on computed tomography (CT) scan or magnetic resonance imaging (MRI). AND Positron emission tomography (PET)-positive on PET-CT scan
Must have newly diagnosed, histologically confirmed CD20+ diffuse large B-cell lymphoma [DLBCL] (de novo or histologically transformed from a diagnosis of follicular lymphoma) at most recent representative tumor biopsy based on the pathology report, with a World Health Organization (WHO) 2016 classification and including: DLBCL, Not Otherwise Specified (NOS), High grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 rearrangement with DLBCL morphology, T-cell/histiocyte-rich large B-cell lymphoma, Epstein Barr virus-positive DLBCL, NOS, Follicular lymphoma Grade 3b. Note: The local pathology report must be available at Screening to support CD20+ DLBCL histology
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 76 months
Awards & highlights

EPCORE DLBCL-2 Trial Summary

This trial will study an investigational drug, epcoritamab, to assess its effect on disease activity in people with a form of cancer called diffuse large B-cell lymphoma (DLBCL). 900 participants will be enrolled in 315 sites globally.

Who is the study for?
Adults with newly diagnosed CD20+ diffuse large B-cell lymphoma (DLBCL) who have not had prior systemic anti-lymphoma therapy, except certain steroids or vincristine for pre-treatment. Participants must have a specific level of disease severity (IPI score 2-5), be able to perform daily activities (ECOG score 0-2), and meet certain health criteria including heart function and measurable lesions.Check my eligibility
What is being tested?
The trial is testing the effectiveness of Epcoritamab combined with R-CHOP chemotherapy compared to standard R-CHOP alone in treating DLBCL. Patients are randomly assigned to one of two groups: one receiving subcutaneous Epcoritamab plus R-CHOP, the other receiving just R-CHOP followed by Rituximab, both in cycles lasting 21 days.See study design
What are the potential side effects?
Potential side effects include reactions at the injection site for Epcoritamab, as well as common chemotherapy-related side effects such as nausea, hair loss, fatigue, increased risk of infection due to low blood cell counts, and potential heart issues from Doxorubicin.

EPCORE DLBCL-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a tumor visible on scans and it's active on a PET scan.
Select...
I have been diagnosed with a specific type of lymphoma called CD20+ DLBCL.
Select...
My lymphoma does not include specific high-risk types like Hodgkin's or Burkitt.

EPCORE DLBCL-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 76 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 76 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Progression-Free Survival (PFS) with an International Prognostic Index (IPI) of 3-5
Secondary outcome measures
Number of Participants with Event-free survival (EFS)
Number of Participants with PFS
Overall survival (OS)
+2 more

EPCORE DLBCL-2 Trial Design

2Treatment groups
Experimental Treatment
Group I: R-CHOP and RituximabExperimental Treatment5 Interventions
Participants will receive intravenous and oral R-CHOP followed by intravenous rituximab in 21-day cycles.
Group II: Epcoritamab and R-CHOPExperimental Treatment6 Interventions
Participants will receive subcutaneous epcoritamab combined with intravenous and oral rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) followed by epcoritamab in 21-day cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3780
Rituximab
1999
Completed Phase 4
~1880
Vincristine
2003
Completed Phase 4
~2910
Doxorubicin
2012
Completed Phase 3
~7940
Prednisone
2014
Completed Phase 4
~2370

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
950 Previous Clinical Trials
496,028 Total Patients Enrolled
GenmabIndustry Sponsor
56 Previous Clinical Trials
11,332 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
390 Previous Clinical Trials
140,819 Total Patients Enrolled

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05578976 — Phase 3
Non-Hodgkin's Lymphoma Research Study Groups: Epcoritamab and R-CHOP, R-CHOP and Rituximab
Non-Hodgkin's Lymphoma Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT05578976 — Phase 3
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05578976 — Phase 3

Frequently Asked Questions

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

Does this research involve participants that are 20 or older?

"The age range that is able to enroll in this clinical trial, as specified by the eligibility criteria, is 18 to 79 years old."

Answered by AI

How does the safety profile of R-CHOP and Rituximab compare to other similar treatments?

"The safety of R-CHOP and Rituximab was given a score of 3. This is based on the fact that this is a Phase 3 trial - meaning that there is efficacy data as well as multiple rounds of data in support of safety."

Answered by AI

Is this research still enrolling new participants?

"The clinical trial in question is no longer looking for participants, as indicated by the fact that it was last updated over 8 months ago. However, there are 1807 other studies that are still recruiting patients."

Answered by AI

Who meets the qualifications to participate in this clinical trial?

"This clinical trial is looking for 900 participants that have diffuse large b-cell lymphoma (dlbcl). The patients must be 18-79 years old and meet the following criteria: They must be planned to receive treatment with 6 cycles of standard rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) per investigator determination., DLBCL, Not Otherwise Specified (NOS)., High grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 rearrangement with"

Answered by AI

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
~600 spots leftby Jan 2027