All studies
Active not recruitingPHASE3INTERVENTIONAL

Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma

This study is investigating a new treatment for adults with follicular lymphoma, a common type of B-cell cancer. Unfortunately, this cancer often returns. The new drug, epcoritamab, is being tested alongside two standard medicines, rituximab and lenalidomide (known as R2), to see if this combination can help people whose lymphoma has come back or not responded to previous treatments. Researchers want to understand how safe this new combination is and how well it works to reduce the cancer's activity. Around 500 adults from many hospitals worldwide will take part in this Phase 3 trial. Participants will receive either the R2 medicines alone or in combination with epcoritamab, which is given by injection.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Genmab
Enrolment target
549
Start
20 Sep 2022
Estimated completion
01 Dec 2029

What is this study about?

Follicular lymphoma is a type of cancer that affects a particular kind of white blood cell called B-cells. It's the second most common B-cell cancer. While standard treatments are available, this cancer often comes back, and it's not currently curable. Because of this, doctors are always looking for new and better ways to treat it, especially when it returns or doesn't respond to earlier treatments.

This study is testing a new medicine called epcoritamab. It's an experimental drug, meaning it's still being investigated and is not yet approved as a standard treatment. In this trial, epcoritamab is being given alongside two established medications, rituximab and lenalidomide, often referred to as R2. The main goal is to find out if this new combination is both safe and effective for adults who have follicular lymphoma that has either returned after initial treatment or hasn't responded to previous therapies.

The study will involve about 500 adults from hospitals around the world. These adults will be divided into different groups, and each group will receive a specific treatment. Researchers will carefully watch for any side effects and see how the cancer changes over time. The information gathered from this study will help doctors understand if this new combination could be a useful option for future patients with follicular lymphoma.

Key takeaways

  • New experimental drug (epcoritamab) being tested for follicular lymphoma.
  • Aims to improve treatment for lymphoma that has come back or not responded.
  • Involves a combination of new and standard medicines (R2).
  • Requires regular hospital visits, tests, and monitoring.
  • Around 500 adults with follicular lymphoma will participate globally.
  • Researchers are looking for both safety and effectiveness.

Who may be eligible?

To join this study, your doctor will check if you meet certain criteria. You would generally need to have a good level of physical activity, meaning you can mostly go about your day without much difficulty. You'll also need to have clear signs of follicular lymphoma that can be measured on scans, and it must be a specific type of follicular lymphoma confirmed by earlier tests.

Crucially, your lymphoma must have come back (relapsed) or not responded well (refractory) to at least one previous treatment that included a medicine called an anti-CD20 antibody combined with chemotherapy. This means if you've only had anti-CD20 medicine by itself or radiation, this study wouldn't be suitable for you.

There are also some reasons why you might not be able to join. For example, if you've previously not responded to lenalidomide, or if you've taken lenalidomide within the last 12 months, you wouldn't be eligible. Your kidney function also needs to be at a certain level.

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 an adult aged 18 or older with follicular lymphoma?
  2. Has your lymphoma come back or not responded to previous treatments that included an 'anti-CD20' drug and chemotherapy?
  3. Do you feel physically well enough to carry out most daily activities?
  4. Have you not taken the medicine lenalidomide in the last 12 months, or had a previous bad reaction to it?
  5. Are your kidneys working well enough?
Answer every question to see your result.

What does participation involve?

If you join this study, you will be placed into one of three treatment groups by the study doctors, though one of these groups is already full. You will either receive the standard R2 treatment (rituximab given by a drip and lenalidomide by mouth) or the R2 treatment combined with epcoritamab, which is given as an injection under the skin. The rituximab will be given for up to 5 cycles, and lenalidomide and epcoritamab (if you receive it) will be given for up to 12 cycles. Each cycle lasts 28 days.

Taking part in this study will likely mean more hospital or clinic visits than your usual care would require. During these visits, doctors will perform medical checks, take blood samples, ask about any side effects you might be experiencing, and have you fill out questionnaires. These regular checks are important to see how you are responding to the treatment and to monitor your health. The total duration of your participation will depend on your treatment plan and how you respond.

Potential risks and benefits

Participating in a clinical trial like this may offer potential benefits, such as access to a new experimental treatment that is not yet widely available. However, there are also potential risks involved, including side effects from the study drugs. The treatment burden might be higher than standard care due to more frequent visits and tests. Your safety will be closely monitored throughout the study. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (273)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • The University of Arizona Cancer Center - North Campus /ID# 228862
    Verified postcode
    Tucson, United States
  • University of Arkansas for Medical Sciences /ID# 227198
    Verified postcode
    Little Rock, United States
  • Alta Bates Summit Medical Center for Research /ID# 229428
    Verified postcode
    Berkeley, United States
  • Beverly Hills Cancer Center /ID# 231535
    Verified postcode
    Beverly Hills, United States
  • Long Beach Memorial Medical Ct /ID# 228997
    Verified postcode
    Long Beach, United States
  • University of Southern California /ID# 227195
    Verified postcode
    Los Angeles, United States
  • Valkyrie Clinical Trials /ID# 268502
    Verified postcode
    Los Angeles, United States
  • Duplicate_Emory University /ID# 227299
    Verified postcode
    Atlanta, United States
  • Hawaii Cancer Care - Waterfront Plaza /ID# 262448
    Verified postcode
    Honolulu, United States
  • Northwestern University Feinberg School of Medicine /ID# 227248
    Verified postcode
    Chicago, United States
  • Goshen Center for Cancer Care /ID# 227189
    Verified postcode
    Goshen, United States
  • Community Health Network, Inc. /ID# 259756
    Verified postcode
    Indianapolis, United States

Common questions

What is follicular lymphoma?

It's a type of cancer affecting certain white blood cells (B-cells) that often comes back after treatment.

What is epcoritamab?

It's a new, experimental drug being tested in this study to treat follicular lymphoma.

What are R2 medicines?

R2 refers to a combination of two standard medicines, rituximab and lenalidomide.

Why is this study important?

It aims to find better treatments for follicular lymphoma, especially when it has returned or not responded to previous therapies.

Will I have to pay to be in the study?

No, you will not have to pay for the study treatments or visits related to the trial.

How to find out more

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

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.