Multicentre, open-label, phase 1/2 study of LB-208, selective antagonist of the serotonin 5-hydroxytryptamine receptor 1B (HTR1B), in adults with relapse or refractory (r/r) acute myeloid leukaemia (AML) and r/r higher-risk (HR) myelodysplastic syndrome (MDS)
This research study is testing a new drug called LB-208 for adults who have acute myeloid leukaemia (AML) or a type of myelodysplastic syndrome (MDS). These are blood cancers that can be serious. This study is for people whose cancer has either come back after treatment or hasn't responded to previous treatments. It's an early-stage study, meaning it's one of the first times this drug is being tested in a larger group of people after initial safety checks. The main goal is to find out if LB-208 is safe and what side effects it might cause. Researchers will also look at how the body handles the drug and if it helps to control the cancer.
At a glance
What is this study about?
This study is about a new potential medicine, called LB-208, which is being tested for adults diagnosed with certain blood cancers. Specifically, it's for people with acute myeloid leukaemia (AML) or a particular type of myelodysplastic syndrome (MDS). These are conditions where there are problems with cells in the bone marrow, meaning healthy blood cells aren't made as they should be.
It's important to know that this study is for people whose AML or MDS has either returned after they've had treatment before (this is called 'relapsed') or hasn't responded to earlier treatments (this is called 'refractory'). This means that current treatments might not be working for them, and researchers are looking for new options.
The main aim of this study is to find out if LB-208 is safe for people to take and to understand any side effects it might cause. Researchers will carefully check for any unwanted reactions. They will also look at how much of the drug stays in the body and for how long. An important part of the study is to see if the drug helps people's conditions and if it can put their cancer into remission.
Key takeaways
- This study is testing a new drug, LB-208, for specific blood cancers.
- It's for adults whose AML or MDS has returned or not responded to prior treatments.
- The main goals are to study the safety and side effects of LB-208.
- Researchers will also see if the drug helps improve the conditions.
- Participation involves regular clinic visits and close medical monitoring.
Who may be eligible?
This study is looking for adults aged 18 or over. It is open to both men and women.
You would be considered for this study if you have been diagnosed with acute myeloid leukaemia (AML) or a higher-risk type of myelodysplastic syndrome (MDS). Crucially, your condition must have either come back after previous treatment, or it must not have responded to treatments you've had in the past.
There will be other detailed medical checks to make sure this study is right and safe for you. This will include looking at your overall health and any other medical conditions you might have.
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 Acute Myeloid Leukaemia (AML)?
- Or have you been diagnosed with a higher-risk type of Myelodysplastic Syndrome (MDS)?
- Has your AML or MDS either come back or not responded to previous treatments?
What does participation involve?
Taking part in this study would involve regular visits to the hospital or clinic. During these visits, the study team would give you the study drug, LB-208, and you would have various medical checks. These checks would include blood tests, physical examinations, and possibly other tests to see how the medicine is affecting you and your condition. The study team would carefully monitor you for any side effects.
You would need to take the study medicine as instructed. The exact number of visits and the full duration of your participation would depend on how your body responds to the treatment and what the doctors decide is best for you. There will also be follow-up appointments after you stop taking the study drug to make sure you are doing well.
Potential risks and benefits
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Common questions
What is AML and MDS?
AML (Acute Myeloid Leukaemia) and MDS (Myelodysplastic Syndrome) are serious conditions that affect how your body makes blood cells in the bone marrow.
What does 'relapsed or refractory' mean?
It means your condition has either come back after treatment or hasn't responded to previous treatments you've had.
What is LB-208?
LB-208 is a new experimental medicine being tested in this study. It's designed to work in a specific way against these blood cancers.
What is a 'Phase 1/2' study?
This means it's an early-stage study primarily focused on checking the safety of the new drug and finding the right dose, while also looking for signs that it might be working.
Will I get the new drug or a placebo?
Based on the description, everyone in this study will receive the new drug, LB-208. There is no mention of a placebo.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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