All studies
Active not recruitingPHASE3INTERVENTIONAL

A Study of Subcutaneously Injected Epcoritamab Plus Oral Lenalidomide Tablets Compared to Intravenously (IV) Infused Rituximab Plus IV Infused Gemcitabine and IV Infused Oxaliplatin in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

This study is for adults with a type of aggressive blood cancer called Diffuse Large B-Cell Lymphoma (DLBCL) that has either returned or not reacted well to previous treatments. Researchers want to compare a new medicine called epcoritamab, often combined with lenalidomide, against a standard treatment which includes rituximab, gemcitabine, and oxaliplatin. The main goal is to find out if the new treatments are safe and effective. Participants will be divided into three groups, each receiving a different treatment for several months. Doctors will regularly check their health, monitor for side effects, and see how their cancer responds. There will be frequent hospital visits for participants.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Genmab
Enrolment target
379
Start
13 Aug 2024
Estimated completion
01 Mar 2028

What is this study about?

You're probably reading this because you, or someone you know, has Diffuse Large B-Cell Lymphoma (DLBCL). This is a serious type of blood cancer that affects certain white blood cells. When we talk about "relapsed or refractory" DLBCL, it means the cancer has come back after treatment, or it hasn't responded to earlier treatments.

This study is looking for better ways to treat DLBCL in these situations. It's comparing a new drug, epcoritamab, sometimes given with another medicine called lenalidomide, against a treatment that's more commonly used, which involves rituximab, gemcitabine, and oxaliplatin. The main aim is to see if the new treatments are safe and work well to control the cancer.

About 360 adults from around the world will take part. Participants will be put into one of three different treatment groups, and their health will be closely watched throughout the study. This research is incredibly important because it could lead to new and more effective treatments for people living with DLBCL who need other options.

Key takeaways

  • New treatments for DLBCL are being tested.
  • Compares a new drug (epcoritamab) with existing treatments.
  • For adults with DLBCL that has come back or not responded.
  • Participation involves regular hospital visits and close monitoring.
  • You can withdraw from the study at any time.

Who may be eligible?

To join this study, you generally need to be an adult (18 years or older) with Diffuse Large B-Cell Lymphoma (DLBCL) that has returned or hasn't responded to previous treatments. Your doctors must have confirmed that your specific type of lymphoma is called CD20+ DLBCL.

You would have already received at least one course of cancer treatment that included a medicine like rituximab. You'd also need to be in reasonably good health overall, with a life expectancy of more than three months. The study is specifically for those who either haven't benefited from, or can't have, certain other advanced treatments like a stem cell transplant or CAR T-cell therapy.

However, you wouldn't be able to join if your lymphoma is in your brain or spinal cord, or if you've already had certain drugs that are similar to the ones being tested in this study (like highly specific CD3 and CD20 targeting drugs, or the full R-GemOx treatment). They also need to be able to measure your cancer, so they can track if the treatment is working.

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 over?
  2. Do you have Diffuse Large B-Cell Lymphoma (DLBCL) that has returned or not responded to previous treatments?
  3. Have you already had at least one course of cancer treatment including a drug like rituximab?
  4. Are you unable to have or benefit from a stem cell transplant or CAR T-cell therapy?
  5. Is your lymphoma NOT in your brain or spinal cord?
  6. Have you NOT had certain similar experimental drugs before?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to one of three treatment groups. Two groups will receive epcoritamab, given as injections under the skin, for up to 12 cycles. One of these groups will also take lenalidomide tablets. The third group will receive rituximab, gemcitabine, and oxaliplatin, given through a drip into a vein, for up to 4 cycles. Each cycle of treatment lasts for 28 days.

Taking part means you will have regular visits to the hospital or clinic. These visits will involve various medical checks, including blood tests, physical exams, and discussions about any side effects you might be experiencing. You'll also be asked to fill out questionnaires about how you're feeling. The medical team will closely monitor your condition and how your cancer is responding to the treatment throughout the study. This will likely involve more hospital visits and tests than you might expect with standard care, and the total duration of your active participation could be several months, depending on your assigned treatment arm.

Potential risks and benefits

Participating in any clinical trial involves potential benefits and risks. The potential benefits of joining this study include getting access to new, experimental treatments like epcoritamab, which might be more effective for your cancer if other treatments haven't worked or aren't suitable. You'll also receive very close medical monitoring from experts. However, there are risks, such as experiencing side effects from the study drugs – some of which might be severe or unexpected. The new drugs are still undergoing testing, so their full safety profile isn't yet known. It's also possible that the treatment might not work for you. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (176)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • City of Hope National Medical Center /ID# 273338
    Verified postcode
    Duarte, United States
  • Valkyrie Clinical Trials /ID# 269935
    Verified postcode
    Los Angeles, United States
  • Desert Regional Medical Center /ID# 272437
    Verified postcode
    Palm Springs, United States
  • Lutheran Medical Center- Cancer Centers of Colorado /ID# 265823
    Verified postcode
    Golden, United States
  • City Of Hope - Atlanta. /ID# 273092
    Verified postcode
    Newnan, United States
  • Rush University Medical Center /ID# 242103
    Verified postcode
    Chicago, United States
  • City Of Hope - Chicago /ID# 274430
    Verified postcode
    Zion, United States
  • Northwest Cancer Center - Dyer Clinic /ID# 269787
    Verified postcode
    Dyer, United States
  • Cancer Center of Kansas - Wichita /ID# 270117
    Verified postcode
    Wichita, United States
  • University of Kentucky Chandler Medical Center. /ID# 242087
    Verified postcode
    Lexington, United States
  • University of Maryland, Baltimore /ID# 242216
    Verified postcode
    Baltimore, United States
  • Henry Ford Hospital /ID# 266446
    Verified postcode
    Detroit, United States

Common questions

What is Diffuse Large B-Cell Lymphoma (DLBCL)?

DLBCL is an aggressive cancer that affects white blood cells called B-cells, which are part of your immune system.

What does 'relapsed or refractory' mean?

It means your cancer has come back after treatment, or it hasn't responded well to previous treatments you've had.

What is epcoritamab?

Epcoritamab is a new investigational drug being tested to see if it can help treat DLBCL. It's not yet widely available.

How long does a treatment cycle last?

Each treatment cycle in this study is 28 days long. Some treatments last for up to 12 cycles, others up to 4 cycles.

Can I stop being part of the study if I want to?

Yes, you can choose to leave the study at any time, for any reason, and it won't affect your future 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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