Active not recruitingPHASE3INTERVENTIONAL

Study to Compare the Effectiveness and Safety of Golcadomide Plus R-CHOP vs Placebo Plus R-CHOP in Participants With Previously Untreated High-risk Large B-cell Lymphoma

This research study is investigating a new treatment approach for a type of cancer called large B-cell lymphoma (LBCL). Specifically, it's for people who have high-risk LBCL that hasn't been treated before. The study aims to compare a new medicine called Golcadomide, given alongside a common chemotherapy treatment called R-CHOP, against R-CHOP chemotherapy given with a placebo (a dummy drug). Researchers want to find out if adding Golcadomide makes the treatment more effective and if it's safe to use. By comparing these two groups, they hope to learn if this new combination could offer a better way to treat this cancer for patients aged 18 to 80.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Celgene

Enrolment target

850

Start

19 Jun 2024

Estimated completion

20 Nov 2029

Large B-cell Lymphoma

What is this study about?

This study is about a type of blood cancer called large B-cell lymphoma, or LBCL for short. This kind of cancer affects white blood cells called B-cells. For people who are newly diagnosed with LBCL and have a more aggressive, 'high-risk' form of the disease, doctors are always looking for better ways to treat it.

The usual treatment for many people with this cancer is a combination of powerful drugs called R-CHOP. In this study, doctors are exploring if adding a new drug, called Golcadomide, to the R-CHOP treatment can improve how well patients respond and if it's safe. Half of the patients will receive Golcadomide with R-CHOP, and the other half will receive a dummy drug (placebo) with R-CHOP. This is a common way to test new medicines to see if they truly make a difference.

The main goal is to compare these two groups to see if the Golcadomide combination leads to better outcomes for patients, like improving their chances of recovery, and to understand any side effects it might cause. By doing this research, doctors hope to find more effective treatments to help people with high-risk large B-cell lymphoma in the future.

Key takeaways

Tests a new drug (Golcadomide) with standard R-CHOP chemotherapy.
For high-risk large B-cell lymphoma patients who haven't had treatment before.
Aims to see if this new combination is safer and more effective.
Compares the new drug + R-CHOP to a dummy drug + R-CHOP.
Participants aged 18 to 80 may be eligible.
Very close medical monitoring is provided for participants.

Who may be eligible?

To join this study, you would need to have been diagnosed with a type of large B-cell lymphoma that hasn't been treated before. This includes certain specific kinds of LBCL, such as Diffuse Large B-cell Lymphoma (DLBCL).

Your cancer must also be considered 'high-risk' based on certain medical scores or if you have a large tumour. Doctors will check if your cancer can be seen clearly on scans (like CT or MRI) or has specific features found in blood tests. You must also have cancer that has spread beyond just one area, typically to two or more areas of your body.

There are also reasons why you might not be able to join. For example, if you have any other serious medical problems, active infections, or other types of lymphoma not covered by the study. If your lymphoma has spread to your brain or spinal cord, you also wouldn't be able to participate. Your medical team will go through all the detailed requirements to see if this study is suitable for you.

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.

I have been diagnosed with large B-cell lymphoma (LBCL).
I haven't received any treatment for my LBCL yet.
My doctors have told me my LBCL is considered 'high-risk' or aggressive.
My cancer can be seen on scans (like CT or MRI) or through other tests.
I am between 18 and 80 years old.
My lymphoma has not spread to my brain or spinal cord.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the new drug Golcadomide or a placebo (a dummy drug), in addition to the standard R-CHOP chemotherapy. The exact schedule for taking these medicines will be explained by your study team. You would have regular visits to the clinic for treatments, check-ups, blood tests, and scans (like CT or MRI) to monitor your health and how the treatment is working.

These visits will allow the doctors to keep a close eye on your progress and any side effects. You would also have follow-up appointments after your treatment finishes. The total duration of your participation, including treatment and follow-up, would be fully explained before you agree to join the study.

Potential risks and benefits

Participating in a study like this could offer potential benefits, such as gaining access to a new experimental treatment (Golcadomide) before it's widely available. You would also receive very close medical attention and monitoring from a team of experts. However, there are potential risks, including side effects from the chemotherapy and the new drug, which might be unknown or worse than standard treatments. There's also no guarantee that the new treatment will work better than the existing one. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (325)

Local Institution - 0014
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Mobile, United States
Local Institution - 0477
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Anchorage, United States
Local Institution - 0452
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Phoenix, United States
Local Institution - 0342
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San Francisco, United States
Local Institution - 0497
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Fort Myers, United States
Local Institution - 0287
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Jacksonville, United States
Local Institution - 0415
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Margate, United States
Local Institution - 0045
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Miami Beach, United States
Local Institution - 0012
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Pensacola, United States
Local Institution - 0502
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St. Petersburg, United States
Local Institution - 0414
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Tampa, United States
Local Institution - 0192
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West Palm Beach, United States

Common questions

What is large B-cell lymphoma?

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

What is R-CHOP?

R-CHOP is a common and effective combination of several chemotherapy drugs and a steroid used to treat lymphoma.

What is Golcadomide?

Golcadomide is a new drug being tested to see if it can improve the effectiveness of R-CHOP for this cancer.

What is a placebo?

A placebo is a 'dummy' treatment that looks like the real drug but contains no active medicine. It helps researchers compare the new drug's effects.

Who is funding this study?

Typically, drug companies or research organisations fund these types of clinical trials.