Relapsed Diffuse Large B-cell Lymphoma (DLBCL)EPKEY_HSRNCT07393204
Italian Real-World Study of Epcoritamab in Relapsed or Refractory DLBCL
An observational study of Relapsed Diffuse Large B-cell Lymphoma (DLBCL) and Refractory Diffuse Large B-Cell Lymphoma, run by Andrés José Maria Ferreri at 1 site in Italy.
Trial summary
This study describes the effectiveness of epcoritamab outside the clinical trial setting in pts with DLBCL relapsed or refractory after 2 or more previous lines of therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed Diffuse Large B-cell Lymphoma (DLBCL), Refractory Diffuse Large B-Cell Lymphoma
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 10 Dec 2025to 10 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study is expected to include approximately 150 patients. Patients registered in the Cnn program of epcoritamab (between February 19, 2024 and September 25, 2024) that received at least 1 dose of this antibody.
Who may be able to join
- Age ≥ 18 years
- Patients registered in the Cnn program of epcoritamab (between February 19, 2024 and September 25, 2024)
- Received at least one dose of epcoritamab
- Free and voluntary written informed consent
Who cannot join
- Age < 18 years
- Patients who received epcoritamab outside the Cnn program (e.g., open access program, compassionate use, off-label, prospective trials).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Italian Real-world Study on Epcoritamab in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma
This study describes the effectiveness of epcoritamab outside the clinical trial setting in pts with DLBCL relapsed or refractory after 2 or more previous lines of therapy
- Keywords
- DLBCL, relapsed, refractory
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Epcoritamab treatment | Patients registered in the Cnn program of epcoritamab (between February 19, 2024 and September 25, 2024) that received at least 1 dose of this antibody. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
Overall Response Rate (ORR), defined as the best objective response achieved during or after treatment with epcoritamab, according to Lugano Criteria
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary outcomes (11)
Adverse Event according to CTCAE v5.0
rate and severity of AEs (Adverse Event), AESIs (adverse events of special interest) and SAEs (Serious Adverse Event) according to the Common Terminology Criteria for Adverse Events (CTCAE v.5.0)
Measured: through study completion, an average of 1 year
Incidence and Severity of Cytokine Release Syndrome (CRS)
Incidence and Severity of Cytokine Release Syndrome (CRS) according to ASTCT CRS grading criteria
Measured: through study completion, an average of 1 year
Incidence and Severity of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
ICANS graded according to ASTCT ICANS grading criteria (ICE score)
Measured: through study completion, an average of 1 year
Complete Response rate
CR rate defined as the proportion of patients with CR, according to Lugano Criteria at 1, 2, 3, 6, 9 and 12 months since treatment start
Measured: through study completion, an average of 1 year
Duration of Response
DoR is defined as the time from the first documentation of response (CR or PR) to the date of PD or death, whichever occurs earlier.
Measured: through study completion, an average of 1 year
Duration of Complete Response
DoCR is defined as the time from the first documentation of CR to the date of PD or death, whichever occurs earlier.
Measured: through study completion, an average of 1 year
Progression Free Survival
PFS is defined as the time from the start of the treatment to first documented PD or death due to any cause, whichever occurs earlier.
Measured: through study completion, an average of 1 year
Overall Survival
OS is defined as the time from the start of epcoritamab treatment to death
Measured: through study completion, an average of 1 year
Time To Next Treatment
TTNT is defined as duration from treatment initiation to the start of new anti-lymphoma therapy or death due to PD, whichever occurs earlier
Measured: through study completion, an average of 1 year
Duration of Treatment
Duration of Treatment (DoT) is defined as the time from the start of the treatment to discontinuation or death due to any cause, whichever occurs earlier.
Measured: through study completion, an average of 1 year
Health Care Resource Utilization (HCRU)
Health Care Resource Utilization (HCRU) as number and duration of unplanned hospitalizations during treatment and follow-up, number of hematological visits, load of diagnostic exams
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start10 Dec 2025
- Primary completion10 Dec 2026 (estimated)
- Study completion10 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Diffuse Large B-cell Lymphoma (DLBCL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrés José Maria Ferreri
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andrés José Maria Ferreri, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07393204
- Sponsor's protocol ID
- EPKEY_HSR
- Acronym
- EPKEY_HSR
- Status last verified
- Jan 2026
- First submitted
- 22 Dec 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian Real-world Study on Epcoritamab in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT07393204
- Acronym / sponsor ID
- EPKEY_HSR / EPKEY_HSR
- Keywords
- DLBCL, relapsed, refractory
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Andrés José Maria FerreriUniversity, hospital or other
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- 10 Dec 2026 (estimated)
- Study completion
- 10 Dec 2026 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study describes the effectiveness of epcoritamab outside the clinical trial setting in pts with DLBCL relapsed or refractory after 2 or more previous lines of therapy
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epcoritamab treatment | – | –Patients registered in the Cnn program of epcoritamab (between February 19, 2024 and September 25, 2024) that received at least 1 dose of this antibody. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study is expected to include approximately 150 patients. Patients registered in the Cnn program of epcoritamab (between February 19, 2024 and September 25, 2024) that received at least 1 dose of this antibody.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Patients registered in the Cnn program of epcoritamab (between February 19, 2024 and September 25, 2024)
- Received at least one dose of epcoritamab
- Free and voluntary written informed consent
Key exclusion criteria (2 listed)
- Age < 18 years
- Patients who received epcoritamab outside the Cnn program (e.g., open access program, compassionate use, off-label, prospective trials).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Response Rate (ORR)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Overall Response Rate (ORR), defined as the best objective response achieved during or after treatment with epcoritamab, according to Lugano Criteria
11 secondary outcomes
Adverse Event according to CTCAE v5.0
Time frame: through study completion, an average of 1 year
Incidence and Severity of Cytokine Release Syndrome (CRS)
Time frame: through study completion, an average of 1 year
Incidence and Severity of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
Time frame: through study completion, an average of 1 year
Complete Response rate
Time frame: through study completion, an average of 1 year
Duration of Response
Time frame: through study completion, an average of 1 year
Duration of Complete Response
Time frame: through study completion, an average of 1 year
Progression Free Survival
Time frame: through study completion, an average of 1 year
Overall Survival
Time frame: through study completion, an average of 1 year
Time To Next Treatment
Time frame: through study completion, an average of 1 year
Duration of Treatment
Time frame: through study completion, an average of 1 year
Health Care Resource Utilization (HCRU)
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsed Diffuse Large B-cell Lymphoma (DLBCL) and Refractory Diffuse Large B-Cell Lymphoma, run by Andrés José Maria Ferreri at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.