[90Y]Y-PTT Endoradiotherapy in CNS Lymphoma Patients
This study is looking at a new treatment called Y-PTT for a type of cancer in the brain or spinal cord, called CNS lymphoma. This is for people whose lymphoma has either returned or not improved with previous treatments. The study aims to find out if Y-PTT is safe, how well people tolerate it, and if it shows signs of working. A small number of patients will be given different doses of the treatment. A special committee will regularly check if the doses are safe. Participants will receive one dose of Y-PTT given directly into a vein. Researchers will then monitor their health, how the treatment spreads in the body, and its effect on the lymphoma over several months.
At a glance
What is this study about?
This study is about a new treatment called Y-PTT for a type of cancer that affects the brain or spinal cord, known as Central Nervous System (CNS) lymphoma. This can be a challenging condition, especially when it comes back after treatment or doesn't respond well to standard therapies.
The main goal of this study is to see if Y-PTT is a safe treatment and if patients can tolerate it without too many side effects. Researchers also want to find out if it shows any early signs of being effective in shrinking or controlling the lymphoma. Since this is a new treatment being tested, it's called a 'Phase 1/2' study, which means it's still in the early stages of human trials.
Participants will receive one cycle of Y-PTT, which will be given directly into a vein. Researchers will closely monitor patients' health, the way the treatment moves through the body, and any changes in the lymphoma over several months. There won't be a comparison group receiving a different treatment or a placebo in this study, as the focus is on understanding this new treatment's safety and early effects.
Key takeaways
- This study is for CNS lymphoma that has returned or not responded to other treatments.
- It tests a new treatment called Y-PTT to check its safety and early effectiveness.
- Participants will receive one dose of Y-PTT through a vein.
- There will be regular check-ups over several months to monitor health and lymphoma.
- This is an early-stage trial (Phase 1/2) for a new experimental treatment.
- You can withdraw from the study at any time.
Who may be eligible?
To be considered for this study, you must be 18 years or older and weigh less than 180kg. You need to have a confirmed diagnosis of CNS lymphoma that has either returned after previous treatment or hasn't responded to earlier therapies. Importantly, the lymphoma must be within your brain or spinal cord, and there should be measurable signs of it that doctors can see and track.
You also need to have stem cells stored (from a previous collection) that meet certain requirements. If you are a woman who could get pregnant, you must agree to use reliable birth control during the study and for six months afterwards. If you're a man whose partner could get pregnant, similar precautions apply.
Before doing anything for the study, you'll need to understand everything about it and sign a consent form. This ensures you agree to take part and understand what's involved. If you meet these main points, the study team will then check other detailed health criteria to make sure the study is a safe option 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.
- Are you 18 years or older?
- Do you have CNS lymphoma that has come back or not responded to previous treatments?
- Is your lymphoma measurable in your brain or spinal cord?
- Do you have stored stem cells?
- Are you able to use reliable birth control if you or your partner could get pregnant?
- Are you able to understand and sign a consent form?
What does participation involve?
If you decide to take part in this study, you will first have some tests to make sure it's suitable for you. Once enrolled, you will receive one dose of the study drug, Y-PTT, which will be given through a drip into your vein. This is called an "intravenous infusion."
After receiving the treatment, you'll have several hospital visits for a few months. During these visits, the doctors will perform tests to check your health, see how your body handles the treatment, and monitor your lymphoma. These assessments help them understand the safety and early effects of Y-PTT.
Following these initial visits, you will have three more check-ups, spaced about every three months. These follow-up visits are important to continue monitoring your health and to see how your lymphoma is doing over a longer period. The total duration of your participation in the study, from your first visit to your final follow-up, will cover several months.
Potential risks and benefits
Locations (2)
- University Hospital Rechts der IsarVerified postcodeMunich, Germany· Withdrawn
- University Hospital EssenVerified postcodeEssen, Germany· Recruiting
Common questions
What is CNS lymphoma?
CNS lymphoma is a type of cancer that starts in the brain or spinal cord.
What is Y-PTT?
Y-PTT is a new treatment being tested in this study. It's given through a vein.
Will I get a placebo?
No, all participants in this study will receive the Y-PTT treatment; there is no placebo group.
How long will I be in the study?
You'll be in the study for several months, with an initial intense phase of visits and then follow-up visits every three months.
Can I stop participating if I want to?
Yes, you can choose to leave the study at any time, and it won't affect your regular medical care.
How to find out more
Simone Pickel
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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