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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 Previously Untreated Follicular Lymphoma

This research is investigating a new medication called epcoritamab for adults with follicular lymphoma, a type of blood cancer that often comes back. The study aims to find out how safe and effective epcoritamab is when given alongside common treatments like rituximab and lenalidomide (R2). Patients will be split into different groups, each receiving a specific treatment plan. We will be carefully monitoring any side effects and how the disease changes during the study. The goal is to see if this new combination could offer a better way to manage follicular lymphoma for people who are newly diagnosed.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Genmab
Enrolment target
1,095
Start
05 Feb 2024
Estimated completion
01 Nov 2037

What is this study about?

Follicular lymphoma is a common type of blood cancer that affects certain white blood cells. While current treatments can help, the cancer often returns. This means doctors are always looking for new and better ways to treat it, especially for people who are diagnosed for the first time.

This study is focusing on a new drug called epcoritamab. We want to learn more about how well it works and if it's safe when used in combination with other treatments that are already widely used. We're particularly interested in patients who haven't had treatment for their follicular lymphoma before. Your doctors will be carefully checking your health, your cancer, and any side effects throughout the study.

The main aim of this research is to see if adding epcoritamab to existing treatments could be a more effective option for people with newly diagnosed follicular lymphoma. This could potentially lead to improved outcomes and a better quality of life for patients in the future.

Key takeaways

  • The study explores a new drug (epcoritamab) for follicular lymphoma.
  • It's for adults who haven't had treatment for their follicular lymphoma before.
  • You'll receive a combination of medicines as part of a treatment group.
  • Regular hospital/clinic visits, blood tests, and scans will monitor your health.
  • Participation involves either 24 or 120 weeks of treatment and follow-up.
  • This research aims to find better treatments for follicular lymphoma.

Who may be eligible?

To join this study, adult participants must have been diagnosed with a specific type of follicular lymphoma (CD20+, Grade 1 to 3a) that has spread to certain areas of the body (Stage III, IV, or II with a large tumour). Your doctor must also believe that you need treatment for your lymphoma.

You'll need to have had specific scans (PET/CT) showing the lymphoma, and certain blood test results must meet the study's requirements. You should also be generally well enough to take part in the study activities.

There are also some reasons why you might not be able to join. For example, if you've had major surgery very recently or if you have an active serious viral infection like cytomegalovirus (CMV).

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 with follicular lymphoma?
  2. Has your doctor said you need treatment for your lymphoma?
  3. Have you not received treatment for your follicular lymphoma before?
  4. Are you generally well enough to participate in regular hospital visits and treatments?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned to one of five different treatment groups. Each group will receive a different combination of drugs. These treatments will involve a mix of injections under the skin (subcutaneous), injections into a vein (intravenous infusion), and tablets or capsules you take by mouth.

The treatment period will last for either 24 weeks or 120 weeks, depending on which treatment group you are in. Throughout this time, you'll have regular visits to a hospital or clinic. These visits will include medical check-ups, blood tests, and health questionnaires to monitor your progress and check for any side effects. Your doctor will carefully watch how you're responding to the treatment.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to new medications that aren't widely available yet, and contributes to medical knowledge that could help others. However, there are also potential risks, as new treatments can have side effects that are not yet fully understood. Your study doctor will explain all known risks. You can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (266)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • UCSF Fresno /ID# 264712
    Verified postcode
    Fresno, United States· Recruiting
  • Scripps Mercy Hospital /ID# 265393
    Verified postcode
    San Diego, United States· Recruiting
  • Sansum Clinic Research /ID# 261596
    Verified postcode
    Santa Barbara, United States· Recruiting
  • Rocky Mountain Cancer Centers - Boulder /ID# 261203
    Verified postcode
    Boulder, United States· Recruiting
  • Christiana Care Health Service /ID# 261207
    Verified postcode
    Newark, United States· Recruiting
  • Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 262445
    Verified postcode
    Jacksonville, United States· Recruiting
  • Advent Health /ID# 261578
    Verified postcode
    Orlando, United States· Recruiting
  • Orlando Health Cancer Institute /ID# 260983
    Verified postcode
    Orlando, United States· Recruiting
  • Moffitt Cancer Center /ID# 259487
    Verified postcode
    Tampa, United States· Recruiting
  • Beacon Cancer Care - Coeur d'Alene /ID# 260670
    Verified postcode
    Coeur d'Alene, United States· Recruiting
  • Northwestern Medicine - Northwestern Memorial Hospital /ID# 259814
    Verified postcode
    Chicago, United States· Recruiting
  • Cancer Care Specialists Of Central Illinois /ID# 272464
    Verified postcode
    Decatur, United States· Recruiting

Common questions

What is follicular lymphoma (FL)?

Follicular lymphoma is a common type of slow-growing blood cancer that affects white blood cells called lymphocytes.

What is Epcoritamab?

Epcoritamab is a new drug being investigated in this study to see if it can help treat follicular lymphoma.

Will I have to travel for this study?

Yes, you will need to attend regular visits at a hospital or clinic for your treatment and check-ups.

How long will the treatment last?

The treatment will last either 24 weeks or 120 weeks, depending on which treatment group you are in.

Can I stop participating in the study at any time?

Yes, you are free to leave the study at any point, and this will not affect your future medical care.

How to find out more

ABBVIE CALL CENTER

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

Interested in taking part?

Register your interest

Share your details and the research team for "Study of Subcutaneous Epcoritamab in Combination With Intrav…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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