Study of PIT565 in Relapsed and/or Refractory B-cell Malignancies
This research study, called PIT565, is looking for a new treatment for adults in the UK who have specific types of B-cell blood cancers: Non-Hodgkin Lymphoma or Acute Lymphoblastic Leukaemia. These are cancers that have returned or haven't gotten better with standard treatments. The main goals of the study are to find out if PIT565 is safe, what dose works best, and how it should be given. We also want to see if it helps reduce the cancer. Participants will be closely monitored for any side effects and to understand how their body handles the medicine. This is a very early-stage study, meaning it's one of the first times this medicine is being tested in people.
At a glance
What is this study about?
This study is about a new medicine called PIT565, which is being investigated for people with certain types of blood cancer. These cancers are called B-cell Non-Hodgkin Lymphoma and B-cell Acute Lymphoblastic Leukaemia. You might be considered for this study if your cancer has come back after treatment or if treatments you've tried before haven't worked as well as hoped.
The main purpose of this study is to learn more about PIT565. Since it's a new medicine, the first step is to check how safe it is and if there are any side effects. Researchers also want to figure out the best amount (dose) of the medicine to give and the best way to give it to patients. They will be looking very closely at how your body reacts to the medicine and if it helps fight the cancer.
This is what's known as a "Phase 1" study. This means it's one of the first times this medicine is being given to people. It's a key step to understand if PIT565 could become a new treatment option in the future. The study is divided into parts where different doses are tried, and then more patients will receive the chosen dose to gather more information.
Key takeaways
- This study is for a new medicine, PIT565, for certain blood cancers that are difficult to treat.
- It's a very early-stage study to understand the medicine's safety and best dose.
- Participants will receive PIT565 and be closely monitored.
- You might get access to a new treatment, but there are unknown risks and side effects.
- You can stop participating at any time without affecting your normal care.
Who may be eligible?
To join this study, you must be at least 18 years old and in reasonably good health, as assessed by a doctor. You will need to sign a consent form, showing you understand the study and agree to take part.
If you have Non-Hodgkin Lymphoma, your cancer must have come back or not responded to at least two previous treatments, and one of these treatments must have included a specific type of immunotherapy (an αCD20 antibody). Your cancer also needs to be measurable on a scan. If you have B-cell Acute Lymphoblastic Leukaemia, your cancer needs to be active in your bone marrow.
There are also some things that would prevent you from joining. For example, if you have severe allergies to ingredients in the study medicine, certain serious infections, a history of other specific cancers recently, active cancer spread to your brain or spine, or certain active autoimmune diseases. You also can't be taking certain medications that suppress your immune system.
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 B-cell Non-Hodgkin Lymphoma or B-cell Acute Lymphoblastic Leukaemia that has returned or not responded to past treatments?
- Do you feel well enough to participate, as determined by a doctor?
- Do you *not* have any severe allergies to medicines?
- Do you *not* have certain serious infections or other types of active cancer (with some exceptions)?
What does participation involve?
If you decide to take part in this study, you will receive the study medicine, PIT565. The way it's given (for example, as an injection or through a drip) and how often will be decided as the study progresses, as this is part of what the researchers are trying to figure out. You will have regular appointments at the hospital, where the study team will monitor your health very closely. This will involve physical examinations, blood tests, scans, and other checks to see how you are responding to the medicine and to look for any side effects. The total duration of your participation will depend on how you respond to the treatment and the study plan, but you will be informed about the expected length.
Potential risks and benefits
Locations (18)
- University Of MiamiVerified postcodeMiami, United States
- University of Chicago Medical CenterVerified postcodeChicago, United States
- The University of Kansas Clinical Research CtrVerified postcodeFairway, United States
- Memorial Sloan Kettering Cancer CtrVerified postcodeNew York, United States
- Oregon Health Sciences UniversityVerified postcodePortland, United States
- Novartis Investigative SiteVerified postcodeGhent, Belgium
- Novartis Investigative SiteVerified postcodeBeijing, China
- Novartis Investigative SiteVerified postcodeShanghai, China
- Novartis Investigative SiteVerified postcodeTianjin, China
- Novartis Investigative SiteVerified postcodeCréteil, France
- Novartis Investigative SiteVerified postcodeMarseille, France
- Novartis Investigative SiteVerified postcodeTel Aviv, Israel
Common questions
What kind of cancer is this study for?
This study is for adults with specific types of B-cell blood cancers: Non-Hodgkin Lymphoma or Acute Lymphoblastic Leukaemia, especially if they haven't responded well to previous treatments.
What is PIT565?
PIT565 is a new medicine being tested in this study. Researchers are trying to learn more about how it works, what dose is best, and if it's safe and effective.
Will I know if I'm getting the actual medicine?
Yes, this is an 'open-label' study, which means both you and your study doctor will know that you are receiving PIT565.
How long will I be in the study?
The exact length of time you'll be in the study can vary. It depends on how you respond to the treatment and the study plan, but the team will discuss this with you.
Can I stop being in the study if I want to?
Yes, you are free to leave the study at any time, for any reason, and it will not 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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