Active not recruitingPHASE1, PHASE2INTERVENTIONAL

A Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL)

If you have non-Hodgkin lymphoma that has come back or hasn't responded to previous treatments, this study might be for you. Researchers are testing a new medicine called CC-99282. They want to find out if it's safe and if it helps people with this type of lymphoma. The study will look at CC-99282 on its own and also in combination with other anti-lymphoma drugs like Rituximab. By taking part, you could help doctors learn more about potential new treatments, which could make a difference for future patients. Participants will be carefully monitored throughout the study to ensure their safety and well-being.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Celgene

Enrolment target

438

Start

20 May 2019

Estimated completion

09 Feb 2028

Lymphoma, Non-Hodgkin

What is this study about?

This research study is for people in the UK who have non-Hodgkin lymphoma that has either come back after treatment (relapsed) or hasn't fully responded to previous treatments (refractory). This means that standard treatments haven't worked or haven't worked well enough.

The main goal of this study is to learn more about a new medicine called CC-99282. The researchers want to understand how safe it is, what side effects it might have, and if it shows any signs of helping to treat lymphoma. They will be testing CC-99282 by itself and also alongside other established lymphoma treatments like Rituximab, Obinutuzumab, Tafasitamab, and Valemetostat. This will help them see if combining medicines could be more effective.

The study has different parts. Initially, a small group will help doctors find the best and safest dose of CC-99282. Later, more people will join to further test the safety and see how well the treatment works at that chosen dose. There’s also a small part of the study to see if food affects how the body handles CC-99282.

Key takeaways

This study is testing a new medicine (CC-99282) for non-Hodgkin lymphoma that has returned or not responded to prior treatments.
It aims to understand the safety and potential effectiveness of CC-99282 alone and with other lymphoma drugs.
Participants will receive close medical monitoring throughout their involvement.
Taking part could offer access to a new treatment option.
Like all new medicines, there may be side effects, which the medical team will explain.
You can stop participating at any time if you wish without affecting your usual care.

Who may be eligible?

To be considered for this study, you must have non-Hodgkin lymphoma that has returned or hasn't responded to previous treatments. Generally, you would have already tried at least two other types of treatment, or one treatment if you can't have any other standard options. You also need to be fit enough for the study, meaning your everyday activities aren't too limited by your health.

There are certain reasons why you might not be able to join. For example, if your life expectancy is very short (less than two months), or if you've recently had other anti-cancer treatments. People who are on long-term treatments that suppress the immune system, or who have serious heart problems, may also not be suitable for this study.

It's important to remember that these are just some of the main points. Your doctor will carefully check all the details to see if this study is the right fit for you.

Quick self-check

Do I have non-Hodgkin lymphoma that has come back or didn't respond to previous treatments?
Have I already tried at least two other treatments for my lymphoma (or one if I can't have others)?
Am I generally well enough to manage my daily activities?
Do I have a life expectancy of more than two months?
Do I have any serious heart conditions or am I taking long-term immune-suppressing medicines?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will be given the new medicine, CC-99282, either on its own or in combination with other approved lymphoma drugs. You'll have regular visits to the clinic for check-ups, which will include physical examinations, blood tests, and scans to see how you're responding to the treatment and to monitor for any side effects. The exact number of visits and tests will vary depending on which part of the study you are in, but the study team will explain everything in detail. You will be closely monitored throughout your treatment, and there will be follow-up appointments even after treatment finishes to ensure your well-being. The total duration of your involvement in the study will depend on your individual response and safety, but it may span several months or longer.

Potential risks and benefits

Taking part in a clinical trial like this could offer potential benefits, such as access to a new treatment that isn't yet widely available, and you'll receive close medical attention. However, like all medicines, CC-99282 may have side effects, some of which could be serious or unexpected. The study team will explain all known risks to you. You are free to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (66)

Local Institution - 109
Scottsdale, United States
Local Institution - 111
Jacksonville, United States
Local Institution - 102
Tampa, United States
Local Institution - 108
Overland Park, United States
Local Institution - 107
Rochester, United States
Local Institution - 104
St Louis, United States
Local Institution - 103
Hackensack, United States
Local Institution - 101
Houston, United States
Local Institution - 255
Ciudad Autonoma de Buenos Aires, Argentina
Local Institution - 254
Pilar, Argentina
Local Institution - 253
Buenos Aires, Argentina
Local Institution - 701
Salzburg, Austria

+54 more sites — see the official record for the full list.

Common questions

What is Non-Hodgkin Lymphoma?

Non-Hodgkin lymphoma is a type of cancer that starts in white blood cells called lymphocytes, which are part of the body's immune system.

What does 'relapsed or refractory' mean?

'Relapsed' means the cancer has come back after treatment. 'Refractory' means the cancer didn't respond to previous treatments.

Is CC-99282 a new medicine?

Yes, CC-99282 is an investigational new medicine, meaning it's still being tested and is not yet approved for general use.

Will I definitely get the new medicine?

Yes, everyone in this study will receive CC-99282, either by itself or along with other approved lymphoma medicines.

How long will the study last for me?

The exact length of time you'll be in the study can vary. It depends on how you respond to the treatment and the part of the study you're in. The study team will give you more specific details.