Study of PIT565 in relapsed and/or refractory B-cell malignancies
This study, called a "Phase 1" trial, is investigating a new medicine named PIT565. It's designed for adults who have specific types of B-cell cancers (B-cell lymphoma or B-cell leukaemia) that have either returned after treatment or haven't gotten better with existing treatments. The main goal of this early study is to see if PIT565 is safe to use in people and to understand how the body handles it. It's the first time this medication is being given to human volunteers, so researchers will be closely monitoring participants. The study aims to gather important initial information before moving on to larger studies.
At a glance
What is this study about?
This research study is looking into a brand new medicine, called PIT565, for people who have certain types of cancer affecting their B-cells. B-cells are a type of white blood cell, and when they become cancerous, they can lead to conditions like B-cell Non-Hodgkin lymphoma or B-cell acute lymphoblastic leukaemia.
The study is specifically for individuals whose cancer has either come back after treatment (this is called 'relapsed') or hasn't responded well to the treatments they've already received (this is called 'refractory'). Because this is the very first time PIT565 is being given to people, it’s known as a ‘Phase 1’ study. The main aim at this stage is to find out if the medicine is safe and to see how the body reacts to it, rather than focusing on how well it treats the cancer itself.
By carefully studying a small group of people, doctors hope to learn important information about PIT565. This early research is crucial for understanding whether this new medicine could be a potential future treatment option for these challenging cancers. It’s a vital step in developing new ways to help patients.
Key takeaways
- This study tests a new medicine (PIT565) for B-cell cancers.
- It's for cancers that have returned or haven't responded to previous treatments.
- This is a Phase 1 study, focusing on safety and how the medicine works in the body.
- It's the first time PIT565 is being given to humans.
- Eligible participants are adults aged 18 and over with specific B-cell cancers.
Who may be eligible?
This study is open to adults aged 18 and older. There is no upper age limit, so older adults could also take part.
You would be considered for this study if you have been diagnosed with certain types of B-cell cancers. Specifically, this includes B-cell Non-Hodgkin lymphoma or B-cell acute lymphoblastic leukaemia. It's important that your cancer has either come back after you've had previous treatments, or that it hasn't responded well to those treatments.
To find out if you meet all the requirements, including other health conditions, you would need to speak with your doctor. They would review your medical history against a full list of criteria 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 am 18 years old or older.
- I have been diagnosed with B-cell Non-Hodgkin lymphoma or B-cell acute lymphoblastic leukaemia.
- My cancer has either come back after treatment or didn't respond to previous treatments.
- I understand this is an early-stage study testing a new medicine.
- I live in the UK and am eligible for NHS care.
What does participation involve?
If you decide to take part in this study, you would receive the new medicine, PIT565. As this is an early-stage study, you would have regular visits to the hospital or clinic. These visits would involve various tests and checks, such as blood tests, physical examinations, and possibly scans, to monitor your health and how your body is reacting to the medicine. The research team would explain the exact schedule of these visits and tests.
Your participation would involve a commitment over a period that would be fully explained before you agree to join. After receiving the medication, there would likely be a follow-up period where doctors continue to monitor your health and any effects of the study drug. All appointments, tests, and medicines related to the study would be provided and fully explained to you.
Potential risks and benefits
Locations (4)
- —UnverifiedSpain
- —UnverifiedBelgium
- —UnverifiedFrance
- —UnverifiedItaly
Common questions
What kind of cancer is this study for?
This study is for specific types of B-cell cancers, including B-cell Non-Hodgkin lymphoma and B-cell acute lymphoblastic leukaemia, especially if they have returned or haven't improved with past treatments.
What does 'relapsed and/or refractory' mean?
It means the cancer has come back after treatment ('relapsed') or hasn't responded well to previous treatments ('refractory').
What is a 'Phase 1' study?
A Phase 1 study is the first time a new medicine is given to people. The main goal is to check if it's safe and to see how the body handles it.
Will I get the new medicine?
Yes, if you join this particular study, you would receive the new medicine called PIT565, as the aim is to test this new drug.
How old do I need to be to participate?
You need to be 18 years old or older. There is no upper age limit for this study.
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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