A Study on the Tolerability, Safety and Effectiveness of Asciminib in Patients With Philadelphia Chromosome-positive Chronic Myeloid Leukemia in the Chronic Phase in Germany
This study, happening in Germany, is for adults who have a specific type of blood cancer called Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). Researchers want to understand how a new medicine, asciminib, works in real-world settings. They are looking at people who are either newly diagnosed or have tried one other similar type of medicine before. The study will also compare asciminib to other common CML treatments like imatinib, dasatinib, bosutinib, and nilotinib for newly diagnosed patients. The main goal is to see how safe and effective asciminib is for these patients in their day-to-day medical care.
At a glance
What is this study about?
This study is happening in Germany and is focused on improving treatment for adults with a specific type of blood cancer called chronic myeloid leukemia, or CML. What makes this CML special is the presence of something called the 'Philadelphia chromosome.' This is a change in the genes that causes the disease.
The main purpose of this study is to learn more about a medicine called asciminib. Doctors want to see how well it works and if it's safe for patients who are either just finding out they have CML or who have already tried one other CML medicine similar to asciminib. The study is also comparing asciminib to other common CML treatments such as imatinib, dasatinib, bosutinib, and nilotinib, but specifically for people who are newly diagnosed.
By gathering information from patients receiving these treatments as part of their regular care, doctors hope to get a better understanding of how these medicines perform in real life. This kind of research helps improve future treatments for CML, giving patients more options and potentially better outcomes. It's about finding the best way to manage this condition.
Key takeaways
- This study is for adults with a specific type of CML in Germany.
- It wants to see how well asciminib and other CML medicines work in real life.
- You'll get the CML treatment your doctor has already chosen for you.
- Your routine doctor visits will provide the study's information.
- You might fill out questionnaires about how you're feeling.
- You can leave the study at any time without affecting your medical care.
Who may be eligible?
To be part of this study, you need to be an adult (18 years or older) with a confirmed diagnosis of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). You might be eligible if you're newly diagnosed or if you've tried exactly one other specific type of CML medication before. Importantly, your doctor must have already decided that asciminib or one of the other study medications is the right treatment for you as part of your usual care.
There are also some reasons why you might not be able to join. For instance, if you have certain genetic changes in your cancer that affect how well asciminib works, or if you're already taking CML medicine in a way that's not officially approved. You also can't be in another medical study at the same time. You'll need to be able to understand and sign a consent form.
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?
- Have you been diagnosed with Philadelphia chromosome-positive CML?
- Are you newly diagnosed or have you tried only one other CML medication (called a TKI) before?
- Has your doctor already decided that asciminib or another study medication (imatinib, dasatinib, bosutinib, nilotinib) is right for your treatment?
- Are you willing to complete questionnaires occasionally and attend your regular check-ups?
What does participation involve?
If you decide to take part in this study, you won't be getting a new, untested treatment. Instead, you'll be receiving asciminib or another CML medication (like imatinib, dasatinib, bosutinib, or nilotinib) as your doctor has already decided for your regular care. The study largely involves collecting information from your routine follow-up visits with your doctor. This means you'll continue with your usual appointments, and the doctors will simply be noting details about how your treatment is going.
You might also be asked to complete some questionnaires yourself during the study. These questionnaires help understand how you're feeling and how the treatment is affecting your daily life. The doctors will follow your progress over time, but the exact duration of your participation isn't specified, as it generally follows your ongoing treatment plan. The study fits in with your normal medical care, rather than adding extra appointments specifically for research.
Potential risks and benefits
Locations (15)
- Novartis Investigative SiteVerified postcodeMunich, Germany· Recruiting
- Novartis Investigative SiteVerified postcodeBremerhaven, Germany· Recruiting
- Novartis Investigative SiteVerified postcodeOffenbach, Germany· Recruiting
- Novartis Investigative SiteVerified postcodeCologne, Germany· Recruiting
- Novartis Investigative SiteVerified postcodeZittau, Germany· Recruiting
- Novartis Investigative SiteVerified postcodeBad Liebenwerda, Germany· Recruiting
- Novartis Investigative SiteVerified postcodeBerlin, Germany· Recruiting
- Novartis Investigative SiteCity onlyBuchholz Nordheide, Germany· Recruiting
- Novartis Investigative SiteVerified postcodeCottbus, Germany· Recruiting
- Novartis Investigative SiteVerified postcodeDetmold, Germany· Recruiting
- Novartis Investigative SiteVerified postcodeHanover, Germany· Recruiting
- Novartis Investigative SiteVerified postcodeParchim, Germany· Recruiting
Common questions
What is chronic myeloid leukemia (CML)?
CML is a type of cancer that starts in the blood-forming cells of the bone marrow. It usually grows slowly at first.
What does 'Philadelphia chromosome-positive' mean?
This means there's a specific change in two chromosomes that creates a new gene, called BCR::ABL1, which causes the CML cells to grow.
What is asciminib?
Asciminib is a medicine used to treat CML by targeting the specific protein created by the Philadelphia chromosome gene.
Will I get a different treatment if I join this study?
No, you'll receive the CML treatment that your doctor has already decided is best for you as part of your regular care. The study just collects information about it.
How long will I be in the study?
The study collects information over the course of your regular treatment and follow-up. The exact duration for each person isn't stated, but it follows your ongoing care.
How to find out more
Novartis Pharmaceuticals
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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