ACTIVATE - Phase 1 Clinical Trial evaluating the combination of Actinomycin D and venetoclax in patients with Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML)
This research study, called ACTIVATE, is exploring a new treatment approach for acute myeloid leukaemia (AML) in people whose cancer has returned after previous treatment or hasn't responded to it. The study combines two existing medications: Actinomycin D and venetoclax. Doctors want to see if using these two drugs together is more effective than using them separately, and importantly, they want to find the safest and best dose. This is an early-stage study, meaning it's one of the first times this combination is being tested in people. The main goal is to understand how safe the treatment is, what side effects it might cause, and if it shows promise in treating AML. Participants must be at least 18 years old.
At a glance
What is this study about?
This study, called ACTIVATE, is looking into new ways to treat a type of blood cancer called Acute Myeloid Leukaemia (AML). Sometimes, AML can come back after treatment, or it might not respond to the treatments given. When this happens, it's called 'relapsed' or 'refractory' AML, and it can be very difficult to treat.
The study aims to see if combining two existing medicines, Actinomycin D and venetoclax, can be a better treatment option. Both of these drugs are already used in medicine, but doctors want to understand if they work more effectively and safely when given together for this specific type of AML. This is an early phase study, which means it's one of the first times this drug combination is being tested in people. The main goals are to find the right dose of the combined medicines, understand any side effects, and see if the treatment helps control the AML.
By taking part, individuals could help researchers learn more about how to best treat AML that has returned or is hard to treat. This knowledge can then be used to help future patients. The study will carefully monitor participants to ensure their safety and track how their body responds to the new treatment combination.
Key takeaways
- This study investigates a new combination of two existing drugs for AML.
- It's for people whose AML has come back or not responded to earlier treatments.
- The main goals are to find safe doses and see if the treatment works.
- It's an early-stage study, meaning it's one of the first times this combination is being tested in humans.
- Participants must be 18 years or older.
Who may be eligible?
This study is open to adults who are at least 18 years old. Both men and women can take part in this research.
To be eligible, you must have Acute Myeloid Leukaemia (AML) that has either come back after previous treatments (relapsed) or has not responded to previous treatments (refractory). This means your AML is currently active and needs further treatment.
There might be other specific health requirements or conditions that would determine if you can join the study, such as your overall health, how well your organs are working, and what other medical conditions you have. These will be discussed in detail by the study team.
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?
- Do you have a diagnosis of Acute Myeloid Leukaemia (AML)?
- Has your AML come back after previous treatment?
- Has your AML not responded to previous treatments?
What does participation involve?
If you decide to take part in this study, you would first have a number of tests and checks to make sure you are suitable. Once enrolled, you would receive the study medication, which is a combination of Actinomycin D and venetoclax, as directed by the study doctors. This would involve regular visits to the hospital or clinic for treatments, blood tests, and check-ups to monitor your health and how you're responding to the medication.
The study team would closely monitor you for any side effects and make adjustments to your treatment if needed. You would also have follow-up appointments after your treatment period to see how you are doing in the long term. The total duration of your participation, including treatment and follow-up, would be explained to you in detail by the study team before you decide to join.
Potential risks and benefits
Locations (1)
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Common questions
What is Acute Myeloid Leukaemia (AML)?
AML is a type of cancer that affects the blood and bone marrow, which is the soft tissue inside your bones where blood cells are made.
What does 'relapsed' or 'refractory' mean?
Relapsed means your AML has returned after treatment. Refractory means your AML didn't get better or respond to previous treatments.
What are Actinomycin D and venetoclax?
They are both medicines already used to treat certain cancers. This study explores if using them together is more effective for AML.
Why is this study needed?
Doctors are looking for better ways to treat AML, especially when it has returned or is difficult to treat with current methods.
Who is funding this study?
Information about specific funding was not provided, but most studies are funded by medical research organisations, governments, or pharmaceutical companies.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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