A Phase 1/2, Open-label Study Evaluating the Efficacy, Safety, and Pharmacokinetics (PK) of Luveltamab Tazevibulin (STRO-002) in Infants and Children < 12 years of age with CBFA2T3::GLIS2 Acute Myeloid Leukemia (AML)
This research study is looking at a new treatment called luveltamab tazevibulin for young children and babies under 12 who have a particular kind of blood cancer called CBFA2T3::GLIS2 acute myeloid leukaemia (AML). This cancer is a serious condition. The main goal is to find out if this new medicine can help children go into complete remission, meaning the cancer cells can no longer be found. Researchers will also be checking to see if the medicine is safe, noting any side effects it might cause, and learning how it moves through the body. This is an early-stage study, meaning it's one of the first times this medicine is being tested in these young patients. We hope this research will lead to better treatment options for children with this specific type of AML.
At a glance
What is this study about?
This study is about a type of blood cancer called Acute Myeloid Leukaemia (AML), which affects children. Specifically, it's focusing on a particular form of AML known as CBFA2T3::GLIS2 AML, which is a complicated name scientists use to describe a specific genetic change in the cancer cells. Researchers are trying a new medicine called luveltamab tazevibulin to see if it can help children under 12 years old who have this type of AML.
Think of this study in two main parts. The first part (Phase 1) is mostly about checking if the new medicine is safe and finding the right dose for children. The second part (Phase 2) builds on that, looking more closely at how well the medicine works to reduce or get rid of the cancer. The overall aim is to improve treatments for this severe illness in very young patients. We want to understand if this new medicine can help children achieve 'complete remission,' which means tests can no longer find signs of the cancer.
Beyond just seeing if the cancer goes away, the researchers will also be keeping a close eye on several other important things. This includes how long children stay cancer-free, how many side effects the medicine causes, and how long children live after getting the treatment. They will also study how the medicine behaves in the body and if the body develops a reaction to the medicine. All of this information helps doctors understand if this new treatment could be a good choice for these children in the future.
Key takeaways
- This study is testing a new drug for a specific type of childhood blood cancer (AML).
- It's for babies and children under 12 with CBFA2T3::GLIS2 AML.
- The main goal is to see if the new medicine helps children go into remission.
- Researchers will also check for safety and side effects.
- Participation involves regular visits, tests, and closely monitoring your child's health.
Who may be eligible?
This study is open to both boys and girls who have been diagnosed with CBFA2T3::GLIS2 acute myeloid leukaemia (AML). There are no specific age limits mentioned, meaning that babies and children of various ages under 12 who meet the other study requirements may be able to take part.
Taking part in a clinical trial is a big decision, and not everyone will be able to join. Your child's doctor, along with the study team, will carefully review your child's medical history, current health, and specific type of AML to see if they meet all the necessary criteria to be safely included in the study. This is to make sure the study is right for your child and that they can receive the best possible care.
- Does my child have Acute Myeloid Leukaemia (AML)?
- Has my child been diagnosed with the specific type called CBFA2T3::GLIS2 AML?
- Is my child under 12 years old?
- Is my child able to attend regular hospital or clinic visits for treatment and check-ups?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If your child takes part in this study, they will receive the new medicine, luveltamab tazevibulin. The study team will explain exactly how the medicine will be given and how often. They will have regular visits to the clinic or hospital to have check-ups, blood tests, and scans. These tests are important for monitoring your child's health, checking how the medicine is working, and looking for any side effects. You will be told exactly how many visits and tests are needed during the study.
The study will also involve follow-up appointments after the main treatment period to see how your child is doing in the long term. The total duration of participation will be explained to you by the study team, as it can vary depending on your child's response to the treatment and the study's design. Throughout the study, you'll have a dedicated team to support you and answer any questions.
Potential risks and benefits
Locations (7)
- —Spain
- —Denmark
- —Netherlands
- —Germany
- —France
- —Austria
- —Italy
Common questions
What is AML?
AML stands for Acute Myeloid Leukaemia, which is a type of cancer that affects the blood and bone marrow, the soft tissue inside bones where blood cells are made.
What does 'complete remission' mean?
Complete remission means that after treatment, tests can't find any signs of the cancer in the body. It's a positive goal for cancer treatment.
What is the new medicine called?
The new medicine being tested in this study is called luveltamab tazevibulin. It's a long name for a specific type of targeted drug.
Will my child definitely get better?
While we hope every child responds well, there's no guarantee that the new medicine will work for everyone. The study aims to find out how effective it is.
Can I take my child out of the study if we change our minds?
Yes, absolutely. You have the right to withdraw your child from the study at any time, for any reason, without it affecting their future medical care. You just need to tell the study team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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