A Study to Assess Change in Disease State and Adverse Events in Korean Adult Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) or Follicular Lymphoma (FL) Receiving Epcoritamab Injections

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAbbVie

About this trial

Diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) represents approximately 50% of all newly diagnosed patients with non-Hodgkin lymphoma. This study will assess adverse events and change in disease activity in adult Korean participants with DLBCL under routine clinical practice.

Epcoritamab is an approved drug for the treatment of DLBCL and FL. Approximately 175 adult participants who are prescribed epcoritamab by their doctors will be enrolled sites in Korea.

Participants will receive epcoritamab as prescribed by their physician. Participants will be followed for up to 24 weeks.

There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants who have agreed to receive epcoritamab treatment according to the latest approved local label or have already started epcoritamab treatment as per the approved label information at the time of the first administration of epcoritamab.

Participants who voluntarily agree to participate in this study and sign informed consent.

Disqualifiers

Contraindication to epcoritamab as listed on the latest approved local label.

Currently participating in another clinical research except observational study.

Trial population

Adult patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

175 Participants
are grouped into 1 trial group
Group A: Epcoritamab Participants

Trial outcomes

Primary outcomes

1

Percentage of Participants with Adverse Event (AEs)

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An SAE is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above.

Time frame
Up to Approximately 24 Weeks

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: