Study to Evaluate Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-291 Moves Through the Body in Adult Participants With Non-Hodgkin's Lymphoma
This research study is about a new medicine, ABBV-291, for adults who have a specific type of cancer called Non-Hodgkin's Lymphoma. This is the very first time this medicine is being given to people, which is an important step in developing new treatments. The main goals are to carefully watch for any side effects the medicine might cause, understand how it moves through the body, and see if it has any effect on the cancer. Researchers want to make sure the medicine is safe before it can be studied further in larger groups of people. Participants will receive the medicine through a drip into their vein.
At a glance
What is this study about?
This study is all about a new investigational medicine called ABBV-291. It's being developed for adults who have been diagnosed with Non-Hodgkin's Lymphoma, which is a type of cancer that starts in white blood cells called lymphocytes. When a new medicine is created, it has to go through several stages of testing to make sure it's safe and effective.
This particular study is known as a 'Phase I' trial. This means it's the very first time the medicine, ABBV-291, is being given to people. The main aim at this early stage is not to cure the cancer, but to gather important information. Researchers want to find out if the medicine is safe for people to take, what kind of side effects it might cause, and how much of it the body can handle. They will also look at how the medicine moves through the body – for example, how quickly it's absorbed, distributed, and removed.
By carefully observing participants, doctors can learn a lot about this new treatment. This initial information is absolutely essential. If ABBV-291 proves to be safe and manageable, then it can move on to larger studies in the future, where researchers can then focus more on how well it works against the cancer. This careful, step-by-step approach helps ensure that any new treatments developed are as safe and effective as possible.
Key takeaways
- This is a first-time-in-humans study for a new medicine.
- The medicine, ABBV-291, is for adults with Non-Hodgkin's Lymphoma.
- The main goals are to check safety, side effects, and how the body handles the medicine.
- Participation involves receiving the medicine through a drip and regular check-ups.
- It's an early-stage study, so the long-term benefits are unknown.
- You can leave the study at any time.
Who may be eligible?
To be able to join this study, participants must be adults, aged 18 years or older. There is no upper age limit, meaning older adults can also be considered.
Both men and women are welcome to take part in this study. The researchers want to get a broad understanding of how the medicine affects different people.
Beyond age and gender, there will be other specific health requirements that your doctor will need to check. These will include things about your specific type of Non-Hodgkin's Lymphoma, your general health, and any other medical conditions or treatments you might be having. It's really important that these criteria are met to ensure your safety in the study.
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.
- Are you 18 years old or older?
- Do you have a diagnosis of Non-Hodgkin's Lymphoma?
- Are you able to attend regular hospital or clinic visits?
- Are you willing to receive the study medicine through a vein drip?
- Have you discussed this study with your doctor to see if your overall health is suitable?
What does participation involve?
If you decide to take part in this study, you would receive the new medicine, ABBV-291, through a drip into a vein (known as an intravenous infusion). This usually happens at a hospital or clinic. The timing and number of these infusions would be carefully planned by the study doctors.
You would have regular visits to the clinic for check-ups. During these visits, doctors and nurses would perform various assessments. These typically include blood tests, physical examinations, and potentially other tests to monitor your health, check for any side effects, and see how the medicine is working. You would also be asked to report any changes you notice in how you feel.
After you finish receiving the medicine, there would be a period of follow-up visits. These continue to monitor your health and any long-term effects. The total time you would be involved in the study, from your first dose to your last follow-up, would be explained in detail by the study team.
Potential risks and benefits
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Common questions
What is Non-Hodgkin's Lymphoma?
Non-Hodgkin's Lymphoma is a type of cancer that starts in white blood cells called lymphocytes, which are part of your body's immune system.
What does a 'Phase I' clinical trial mean?
A Phase I trial is the very first stage where a new medicine is given to people. The main goal is to check its safety, find the right dose, and see how it works in the body.
Will this medicine cure my cancer?
The main purpose of this early study is to check the medicine's safety and how it behaves in the body, not primarily to cure cancer. Any effects on the cancer would be a secondary observation at this stage.
How will I receive the medicine?
The medicine, ABBV-291, will be given to you directly into a vein through a drip, which is called an intravenous infusion.
Can I leave the study if I change my mind?
Yes, you are free to stop participating in the study at any time, for any reason, without it affecting your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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