Trials Sponsors Conditions Drugs Pricing

Conditions

Diffuse large B-cell lymphoma (DLBCL)

Outcome Measures

Primary Outcomes (1)

The dual primary endpoints are: 1. Complete remission (CR) on or after the End of Treatment (EOT) and 2. • PFS, defined as the duration from the date of randomization to the date of disease progression or death

Secondary Outcomes (2)

Overall survical, MRD negativity, Best overall response, Complete Response, Duration of CR and BOR, Changes in PRO, Duration of MRD negativity
Safety data using descriptive statistics

Interventions

MabThera 100 mg concentrate for solution for infusionType not reported

Epcoritamab (GEN3013)Type not reported

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
MabThera 100 mg concentrate for solution for infusion
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry record
Formulated product
Epcoritamab (GEN3013)
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry record
Formulated product
Epcoritamab (GEN3013)
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry record
Formulated product
MabThera 500 mg concentrate for solution for infusion
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry record
Formulated product

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

MabThera 100 mg concentrate for solution for infusion
Named ingredient: Rituximab
View registry record
Epcoritamab (GEN3013)
Named ingredient: epcoritamab
View registry record
Epcoritamab (GEN3013)
Named ingredient: epcoritamab
View registry record
MabThera 500 mg concentrate for solution for infusion
Named ingredient: Rituximab
View registry record
MabThera 1400 mg solution for subcutaneous injection
Named ingredient: Rituximab
View registry record

Eligibility Criteria

Sexall

Age GroupsOlder Adult (65+)

You may qualify if:

Patients must voluntarily sign and date an informed consent
Adult individuals, at least 70 years old with a life expectancy of ≥ 12 months
Laboratory values meeting the protocol defined criteria within the screening period prior to the first dose of study drug

Sponsors & Collaborators

Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting
Otherlead

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Study Sites (37)

Universitair Ziekenhuis Gent

Gent, 9000, Belgium

Willem Daneels+31107041560 hovon@erasmusmc.nl

UZ Leuven

Leuven, 3000, Belgium

Vibeke Vergote+31107041560 hovon@erasmusmc.nl

AZ ST-JAN Brugge A.V.

Brugge, 8000, Belgium

Sylvia Snauwaert+31107041560

Central Study Contacts

Marleen Breems

0107041560 hovon@erasmusmc.nl

Study Design

Study Type: interventional
Phase: phase 2

Study Record Dates

First Submitted

May 8, 2026

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2025-524230-25-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-30 06:41:42 UTC

Documents

K1 HO168 Recruitement arrangements BE

You may not qualify if:

Patient has history of prior systemic anti-lymphoma therapy for DLBCL
Subject with histologically transformed FL, who has previously been treated with > 1 lines of therapy for FL
Patient has history of primary mediastinal lymphoma, or mediastinal or pericardial radiation
Patient has a primary CNS tumor or known CNS involvement
Patient has: history of severe allergic or anaphylactic reactions to anti-CD20 mAb therapy or known allergy or intolerance to any component or excipient of epcoritamab or CHOP; known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection; active hepatitis B virus or Hepatitis C virus or HIV infection; active tuberculosis or history of completed treatment for active TB within the past 12 months; active (symptomatic) CMV disease; known active SARS-CoV-2 infection; major surgery within 4 weeks prior to randomization; clinically significant cardiovascular disease; LVEF <45%; clinically significant liver disease; history of Progressive Multifocal Leukoencephalopathy; history of other prior malignancies; neuropathy Grade > 1; current seizure disorder requiring therapy within the past 12 months.
Patient has life-threatening illness, medical condition, or organ system dysfunction that, in the Investigator's opinion, could compromise the patient's safety, compliance with the protocol, interpretation of the study results, or put the study outcomes at undue risk.
Patient has medication known to decrease T-cell numbers or activity or other concurrent immunosuppressive medication or has received any live vaccine within 28 days prior to the first dose of study drug or is expected to need any live vaccination during study treatment.
Patient has been treated with any investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of study treatment or is currently taking an investigational drug or is participating in another interventional study until participant is in the survival follow-up phase.
Male patient who is considering fathering a child or donating sperm during the study or for 12 months after the last dose of study drug.

HOVON 168:Study on epcoritamab in frail patients with diffuse large B-Cell lymphoma (DLBCL) who have not been treated before

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (37)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (37)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations