Trials Sponsors Conditions Drugs Pricing

Conditions

Marginal Zone Lymphoma

Outcome Measures

Primary Outcomes (1)

CR rate (CRR) determined 4 weeks after the end of treatment (after 12 cycles of treatment or in the case of early termination at the time point of the early termination visit)

Secondary Outcomes (11)

Overall response rate (ORR) after12 cycles of treatment
Best response (BR): CR and ORR
Time to best response: CR, ORR
Time to first response: CR, ORR
Progression free survival (PFS)
+6 more secondary outcomes

Interventions

Tepkinly 4 mg/0.8 ml solution for injectionType not reported

Tepkinly 48 mg solution for injectionType 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
Tepkinly 4 mg/0.8 ml solution for injection
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry record
Formulated product
Tepkinly 48 mg solution for injection
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry record

Ingredients named in source formulations

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

Tepkinly 4 mg/0.8 ml solution for injection
Named ingredient: epcoritamab
View registry record
Tepkinly 48 mg solution for injection
Named ingredient: epcoritamab
View registry record

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Participants must have a proven pathological diagnosis of MZL, confirmed by a reference pathology center: -Confirmed CD20-positive relapsed/refractory extranoda Lymphoma or -Confirmed CD20-positive relapsed/refractory splenic MZL or -Confirmed CD20-positive relapsed/refractory nodal MZL A tumor biopsy not older than 12 months is required at screening for confirming diagnosis in all participants.
Circulating lymphocytes < 25 G/l

Sponsors & Collaborators

Universitaetsklinikum Ulm AöR
Type not reportedlead

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

Study Sites (13)

Katholisches Klinikum Bochum gGmbH

Bochum, 44791, Germany

Julia von Tresckow+4923450958007 julia.vontresckow@klinikum-bochum.de

Rostock University Medical Center

Rostock, 18057, Germany

Sebastian Böttcher+493814947405 sebastian.boettcher@med.uni-rostock.de

Institut Fuer Versorgungsforschung In Der Onkologie GbR

Koblenz, 56068, Germany

Rudolf Weide

Central Study Contacts

Christian Buske

073150065801 christian.buske@uni-ulm.de

Study Design

Study Type: interventional
Phase: phase 2

Study Record Dates

First Submitted

April 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: 2025-524879-23-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-30 06:46:37 UTC

Documents

D1_Protocol_2025-524879-23-00_public

You may not qualify if:

ECOG performance status ≥ 3
Breastfeeding or Pregnancy
Clinically significant cardiovascular disease, including the following: • Myocardial infarction within 1 year or stroke within 6 months prior to randomization OR • The following conditions within 3 months prior to randomization: unstable or uncontrolled disease/condition related to or affecting cardiac function (e.g., unstable angina (angina symptoms at rest; new onset angina starting within the last 3 months), congestive heart failure > New York Heart Association (NYHA) class II), uncontrolled cardiac arrhythmia, or other clinically significant electrocardiogram (ECG) abnormalities in the opinion of the investigator
Uncontrolled arterial hypertension despite optimal medical management
Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, electrocardiogram (ECG) finding, or laboratory abnormality that, in the investigator’s opinion, could adversely affect the safety of the subject or impair the assessment of study results
Vaccination with a live vaccine within 30 days prior to start of therapy
Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before the start of study medication.
History of severe concurrent interstitial lung and/or severely impaired lung function (as judged by the investigator)
Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment
Has a history of non-infectious pneumonitis that required steroids, or current pneumonitis
History of anaphylaxis in association with previous administration of monoclonal antibodies or severe hypersensitivity (≥ Grade 3) to the investigational medicinal product and/or any of its excipients
History of a non-lymphoid malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate specific antigen for ≥1 year prior to study enrolment visit, other Stage 1 cancer treated with a curative intent and currently in complete remission, for ≥3 years
Has a known history of TB (Bacillus Tuberculosis)
Ongoing alcohol or drug addiction or known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
History of Diagnosis of Stevens-Johnson Syndrome (SJS) or Toxic Epidermal Necrolysis (TEN)
+7 more criteria

Epcoritamab in Relapsed/Refractory Marginalzone Lymphoma - A MULTICENTER OPEN LABEL SINGLE-ARM PHASE II STUDY (EPOS-1)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (13)

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 (11)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (13)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations