Double-blind, Randomized, Placebo-controlled, Prospective Phase III Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients with Chronic Lymphocytic Leukemia (“PRO-SID” study).
This research study, called PRO-SID, is looking into whether a medicine called Panzyga can help protect people with chronic lymphocytic leukaemia (CLL) from getting serious infections. People with CLL often have a weaker immune system, which makes them more vulnerable to infections. Panzyga is designed to boost the body's protection. The study is comparing Panzyga with a dummy treatment (placebo) to see if it reduces the number of participants who experience at least one major infection. Researchers will also look at the overall infection rates and how often other infection-fighting medicines are needed. This is a Phase III study, which means it’s a later stage of research, aiming to confirm if Panzyga is effective and safe.
At a glance
What is this study about?
When you have a condition like chronic lymphocytic leukaemia (CLL), your body's immune system, which usually fights off germs, might not work as well as it should. This can make you more likely to get infections, and sometimes these can be serious.
This study is called PRO-SID, and it’s looking at a medicine called Panzyga. The main idea behind Panzyga is to help boost your immune system and prevent these infections from happening in the first place. Think of it like giving your body an extra layer of protection. This is an important step because preventing infections can greatly improve how someone with CLL feels and reduces the need for strong antibiotics or hospital stays.
In this study, some people will receive Panzyga, while others will receive a dummy treatment (also known as a placebo). This is a standard way to test new medicines to make sure any improvements are truly due to the medicine being studied and not just by chance. The researchers will be carefully monitoring everyone to see if Panzyga can reduce the number of people who get a major infection, as well as looking at overall infection rates and the use of other anti-infection medicines.
Key takeaways
- This study investigates if Panzyga can prevent serious infections in people with CLL.
- It aims to boost the immune system to offer better protection against infections.
- Participants will receive either Panzyga or a dummy treatment (placebo) via infusion.
- The study monitors how often major infections occur and overall infection rates.
- It is a Phase III study, designed to confirm the treatment's safety and effectiveness.
- Participation involves regular clinic visits for monitoring and assessments.
Who may be eligible?
This study is looking for adults aged 18 years and older who have chronic lymphocytic leukaemia (CLL). Both men and women are welcome to take part.
The study is specifically for people with CLL who also have something called 'secondary hypogammaglobulinaemia'. This is a medical term that means your body isn't making enough of certain important immune proteins (antibodies) which help fight infections. Your doctor will be able to tell you if you meet this specific requirement.
There will be other specific health checks and medical history questions to ensure the study is safe and appropriate for you. If you're interested, your doctor will be able to go through all the detailed criteria with you to see if you can join.
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 over?
- Do you have chronic lymphocytic leukaemia (CLL)?
- Has your doctor told you that you have 'secondary hypogammaglobulinaemia'?
- Are you able to attend regular clinic visits for infusions and check-ups?
What does participation involve?
If you decide to take part in this study, you'll be given either Panzyga or a dummy treatment (placebo) through a drip (infusion) into your vein. Neither you nor your study doctor will know which one you are receiving – this is called 'double-blind'. You'll have regular visits to the clinic so the study team can monitor your health, check for any infections, and see how you are responding to the treatment. These visits will involve physical examinations, blood tests, and discussions about how you are feeling. The study will involve a long-term follow-up period to understand the full effects of the treatment. The total duration of your participation will be explained by the study team.
Potential risks and benefits
Locations (7)
- —UnverifiedHungary
- —UnverifiedGreece
- —UnverifiedCzechia
- —UnverifiedItaly
- —UnverifiedSpain
- —UnverifiedPoland
- —UnverifiedDenmark
Common questions
What is chronic lymphocytic leukaemia (CLL)?
CLL is a type of slow-growing blood cancer that affects certain white blood cells, making your immune system weaker and less able to fight infections.
What does 'primary infection prophylaxis' mean?
It means giving a treatment, like Panzyga, to prevent infections from happening in the first place, rather than treating them once they’ve already started.
What is Panzyga?
Panzyga is a medicine given by drip that aims to boost your immune system by providing protective antibodies, helping your body fight off infections more effectively.
Why is a placebo (dummy treatment) used?
Using a placebo helps researchers fairly compare how well the new medicine works by seeing if it has a better effect than no active treatment at all.
Will I know if I'm getting Panzyga or the placebo?
No, neither you nor your study doctor will know, which is called 'double-blind'. This helps make the study results more reliable.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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