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Active not recruitingPHASE1INTERVENTIONAL

Study of the Adverse Events and Change in Disease State of Pediatric Participants (and Young Adults Between the Ages of 18-25) With Relapsed/Refractory Aggressive Mature B-cell Neoplasms Receiving Subcutaneous (SC) Injections of Epcoritamab

This research study is investigating a new medication called epcoritamab for children and young adults (up to age 25) who have a type of cancer called Non-Hodgkin Lymphoma. Specifically, it's for those whose lymphoma has returned after treatment or hasn't responded well to previous therapies. The study wants to find out if epcoritamab, given as an injection under the skin, is safe and how well people can tolerate it. Researchers will also look at how the disease changes during treatment. The goal is to provide valuable information about a potential new treatment option for this specific group of patients, as their current treatment options can be limited.

At a glance

Status
Active not recruiting
Phase
PHASE1
Sponsor
Genmab
Enrolment target
17
Start
04 Oct 2022
Estimated completion
01 Nov 2028

What is this study about?

This study is testing a new medicine called epcoritamab for a specific type of Non-Hodgkin Lymphoma. This cancer affects certain white blood cells (B-cells) and is mostly seen in children and young adults. While initial treatments for this type of lymphoma are often very successful, some children and young adults find that their cancer comes back or doesn't respond to standard treatments. When this happens, it can be very challenging, and new treatment options are urgently needed.

The main purpose of this study is to see how safe epcoritamab is and how well people can cope with its side effects. It's an 'investigational drug,' which means it's still being tested and isn't yet approved for general use. Participants will receive the medicine as an injection under the skin. Researchers will carefully monitor participants to understand the drug's effects and how the cancer might change.

Around 15 children and young adults from different parts of the world will take part. This research is important because it could help doctors understand if epcoritamab might be a helpful new treatment for children and young adults with these more difficult-to-treat lymphomas.

Key takeaways

  • This study is for children (1+) and young adults (up to 25) with certain lymphomas.
  • It's testing a new injected medicine called epcoritamab for lymphoma that has come back or not responded to prior treatment.
  • The main goals are to check the medicine's safety and how well people tolerate it.
  • Participants will have regular clinic visits, blood tests, and health checks for at least 3 years.
  • It could offer a new treatment option for a difficult-to-treat type of lymphoma.

Who may be eligible?

To be considered for this study, children need to be at least 1 year old and young adults up to 25 years old. They must have a confirmed diagnosis of specific types of Non-Hodgkin Lymphoma, including Burkitt's lymphoma or a similar type, or another aggressive B-cell lymphoma.

Crucially, the lymphoma must have either returned after previous treatment or not responded well to those treatments. Doctors will need to confirm this from existing medical tests. Participants also need to have generally recovered from any side effects of their previous cancer treatments and be in reasonably good health overall.

However, there are some reasons why someone might not be able to join. For example, if the lymphoma has spread to the brain or spinal cord (unless it's only in the fluid around them), or if they have another cancer that needs treatment. Also, participants shouldn't be receiving other ongoing cancer treatments at the time of joining.

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.

  1. Are you between 1 and 25 years old?
  2. Do you have a confirmed diagnosis of Burkitt's lymphoma, DLBCL, or a similar aggressive B-cell lymphoma?
  3. Has your lymphoma come back or not responded well to previous treatments?
  4. Have you mostly recovered from side effects of your past cancer treatments?
  5. Is your overall health generally good enough to participate in a study?
Answer every question to see your result.

What does participation involve?

If you join this study, you'll receive the study medicine, epcoritamab, as an injection under your skin. This will happen in treatment cycles, each lasting 28 days. You will need to attend regular appointments at a hospital or clinic approved for the study. These appointments will involve various medical checks to see how you're doing and how the treatment is affecting you.

These checks will include blood tests, filling out questionnaires about your health, and doctors regularly looking for any side effects. Because this is a research study, you might have more appointments and tests than you would normally expect with standard care. After you start the study, you'll be followed closely for at least three years, even after you stop receiving the study medicine.

Potential risks and benefits

Participating in this study might offer a chance to try a new treatment for lymphoma that has come back or hasn't responded to other medicines, especially when other options might be limited. However, as with any new medicine, there are potential risks, including side effects that are not yet fully known. The study aims to understand these side effects. Your health will be closely monitored by a medical team. You have the right to leave the study at any time, for any reason, without it affecting your future medical care.

Locations (41)

  • Lucile Packard Children's Hospital /ID# 240854
    Verified postcode
    Palo Alto, United States
  • Nicklaus Children's Hospital /ID# 241174
    Verified postcode
    Miami, United States
  • New York Medical College /ID# 239208
    Verified postcode
    Valhalla, United States
  • Levine Children's Hospital /ID# 242765
    Verified postcode
    Charlotte, United States
  • Cincinnati Childrens Hospital Medical Center /ID# 239823
    Verified postcode
    Cincinnati, United States
  • Children's Hospital of Philadelphia - Main /ID# 239294
    Verified postcode
    Philadelphia, United States
  • St Jude Children's Research Hospital /ID# 239184
    Verified postcode
    Memphis, United States
  • University of Texas Southwestern Medical Center /ID# 240892
    Verified postcode
    Dallas, United States
  • Children's Hospital at Westmead /ID# 240091
    Verified postcode
    Westmead, Australia
  • Royal Children's Hospital /ID# 240384
    Verified postcode
    Parkville, Australia
  • Perth Children'S Hospital /ID# 240382
    Verified postcode
    Perth, Australia
  • Universitair Ziekenhuis Leuven /ID# 242384
    Verified postcode
    Leuven, Belgium

Common questions

What is Non-Hodgkin Lymphoma?

It's a type of cancer that starts in white blood cells called lymphocytes, which are part of your immune system.

What does 'relapsed/refractory' mean?

It means the cancer has come back after treatment (relapsed) or hasn't responded to previous treatments (refractory).

What is epcoritamab?

It's a new medicine being tested in this study for Non-Hodgkin Lymphoma. It's given as an injection.

How long will the study last?

You'll be followed for at least 3 years after joining, even if you stop treatment earlier.

Can I stop participating in the study?

Yes, you can leave the study at any time without needing to give a reason, and it won't affect your medical care.

How to find out more

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

Discussion

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