RecruitingOBSERVATIONAL

Real-World Study to Assess Subcutaneous Epcoritamab in Adult Participants With Diffuse Large B-Cell and Follicular Lymphoma

This study is gathering information about a new medicine, epcoritamab, for adults with two types of blood cancer: Diffuse Large B-cell Lymphoma (DLBCL) and Follicular Lymphoma (FL). DLBCL is a fast-growing kind of lymphoma, while FL grows more slowly. Epcoritamab is given as an injection under the skin. Researchers want to understand how it works in normal hospital or clinic settings, not just in strict trial conditions. Around 700 people from many countries will take part. Participants will receive epcoritamab as their doctor prescribes, and their health will be monitored for up to three years during their usual clinic appointments. There are no extra tests or visits needed beyond their routine medical care.

At a glance

Status

Recruiting

Sponsor

AbbVie

Enrolment target

700

Start

28 Mar 2025

Estimated completion

01 Sep 2031

Diffuse Large B-cell Lymphoma Follicular Lymphoma

What is this study about?

This study is about understanding how a new medicine, called epcoritamab, works for people living with specific types of blood cancer. These are Diffuse Large B-cell Lymphoma (DLBCL) and Follicular Lymphoma (FL). DLBCL is a type of aggressive cancer that affects certain immune cells (white blood cells that fight infections) and is the most common kind of non-Hodgkin lymphoma. Follicular Lymphoma, on the other hand, is a slower-growing type of non-Hodgkin lymphoma.

Epcoritamab is an investigational drug, meaning it's still being evaluated, but it's already approved for use in some places for these conditions. This study wants to see how well it performs in the 'real world' – that is, when it's used by doctors in their normal practice, rather than under very strict trial conditions. The medicine is given as an injection under the skin.

Around 700 adults with advanced DLBCL or FL will take part across many hospitals and clinics in different countries. The main goal is to see how effective epcoritamab is when used as part of standard care for these types of lymphoma. Participants will be followed for up to three years to see how they are doing with the treatment.

Key takeaways

This study evaluates epcoritamab for Diffuse Large B-cell Lymphoma (DLBCL) or Follicular Lymphoma (FL).
It aims to see how the drug works in a 'real-world' clinical setting.
Participation involves no extra hospital visits or tests beyond your routine care.
Your doctor has already decided epcoritamab is the right treatment for you.
Information will be collected for up to three years from your regular appointments.

Who may be eligible?

The study is looking for adults who are preparing to start treatment with epcoritamab for their Diffuse Large B-cell Lymphoma (DLBCL) or Follicular Lymphoma (FL). For DLBCL, you should have already received at least two other types of treatment. For FL, you also need to have tried at least two previous treatments.

Your doctor must have already decided that epcoritamab is the right treatment for you, independently of this study. The way epcoritamab is given must also follow the approved guidelines in your country.

You cannot join if you have any medical conditions that would make epcoritamab unsafe for you, as listed in the medicine's official information. You also can't be taking part in another clinical trial at the same time, except for certain types of observation studies or registries.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult (18 years or older)?
Do you have Diffuse Large B-cell Lymphoma (DLBCL) or Follicular Lymphoma (FL)?
Have you already had at least two previous treatments for your lymphoma?
Has your doctor already decided that epcoritamab is a suitable treatment for you?
Are you not currently involved in another clinical trial (excluding some observation studies)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive epcoritamab as an injection under your skin, exactly as your doctor prescribes it according to your country's guidelines. This study aims to watch how the medicine works during your regular treatment.

You won't have any extra appointments or tests specifically for this study. All your visits to the hospital or clinic will be part of your normal medical care. The study team will simply collect information from these routine visits for up to three years to see how you respond to the treatment over time. This means there's no additional burden on you beyond your usual visits to manage your condition.

Potential risks and benefits

The main benefit of taking part in this study is that you will receive the treatment your doctor believes is best for your condition, and your information will help researchers understand epcoritamab's effectiveness in a real-world setting. As this is not a traditional interventional trial, you won't be exposed to unknown risks from new procedures; any potential risks would be those associated with epcoritamab itself, which your doctor will discuss with you as part of your treatment plan. You are free to withdraw from the study at any time without affecting your medical care.

Locations (73)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Hospital Britanico de Buenos Aires /ID# 274419
Unverified
Ciudad Autonoma de Buenos Aire, Argentina· Recruiting
Hospital Universitario Austral /ID# 274393
Verified postcode
Pilar, Argentina· Recruiting
Instituto Alexander Fleming /ID# 277284
Unverified
Ciudad Autonoma de Buenos Aire, Argentina· Recruiting
Hospital Privado Universitario De Córdoba /ID# 274457
Verified postcode
Córdoba, Argentina· Recruiting
Hospital Italiano de Buenos Aires /ID# 274418
Verified postcode
Buenos Aires, Argentina· Recruiting
Fundacion Argentina contra la Leucemia (FUNDALEU) /ID# 274390
Verified postcode
Buenos Aires, Argentina· Recruiting
Nepean Cancer Centre, Nepean Hospital /ID# 277782
Verified postcode
Kingswood, Australia· Recruiting
Calvary Mater Newcastle /ID# 277783
Verified postcode
Waratah, Australia· Recruiting
Cabrini Hospital Malvern /ID# 277780
Verified postcode
Malvern, Australia· Recruiting
Krankenhaus Der Barmherzigen Brueder Graz /ID# 273288
Verified postcode
Graz, Austria· Recruiting
Landeskrankenhaus Hochsteiermark, Standort Leoben /ID# 273266
Verified postcode
Leoben, Austria· Recruiting
Algemeen Ziekenhuis klina /ID# 273405
Verified postcode
Brasschaat, Belgium· Recruiting

Common questions

What kind of conditions will this study look into?

This study is for adults with Diffuse Large B-cell Lymphoma (DLBCL) or Follicular Lymphoma (FL), which are types of blood cancer.

What is epcoritamab?

Epcoritamab is a medicine that is being developed and is already approved in some areas to treat DLBCL and FL. It is given as an injection under the skin.

Will I have to make extra hospital visits if I join?

No, you won't have any extra visits. All your hospital or clinic appointments will be part of your usual medical care.

How long will I be followed in this study?

You will be followed for up to three years, as part of your routine medical check-ups.

Who decided I should have epcoritamab treatment?

Your doctor made the decision to treat you with epcoritamab independently, based on what they believe is best for your condition, before considering this study.

How to find out more

Rebekah Taylor

rebekah.taylor@abbvie.com (847) 937-8000 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.