Phase 1/2 Study of Liposomal Annamycin in Combination with Cytarabine for the Treatment of Subjects with Acute Myeloid Leukemia (AML).
This research study is investigating a new way to treat acute myeloid leukemia (AML), which is a type of blood cancer. The study is combining a new drug called Liposomal Annamycin with a commonly used treatment known as cytarabine (sometimes called ALEXAN). This is an early-stage study, meaning researchers are first checking if the new combination treatment is safe for people to take and what the right dose might be. After that, they will look to see how well it works in fighting the cancer. The aim is to find better treatments for AML, which could lead to improved outcomes for patients. Both men and women aged 18 and over are being considered for this study.
At a glance
What is this study about?
This study is about finding new and better ways to treat acute myeloid leukemia (AML). AML is a cancer that affects the blood and bone marrow, which is the spongy material inside your bones where blood cells are made. In AML, the body makes too many abnormal white blood cells.
The study combines a new drug called Liposomal Annamycin with a standard chemotherapy drug called cytarabine (which you might also hear referred to as ALEXAN). Cytarabine is already used to treat AML. Liposomal Annamycin is a newer drug being tested. The word "liposomal" means the drug is specially packaged in tiny fatty bubbles. This packaging can sometimes help the drug get to where it needs to go in the body more effectively and may reduce side effects.
This is a 'Phase 1/2' study. This means it's an early stage of clinical research. In Phase 1, the main goal is to check if the new combination treatment is safe and to find the best dose. Once safety is established, Phase 2 will focus on how well the treatment works against the cancer. The hope is that this new combination will be more effective than current treatments for AML.
Key takeaways
- This study is for adults with Acute Myeloid Leukemia (AML).
- It tests a new drug combination: Liposomal Annamycin plus cytarabine.
- It's a Phase 1/2 study, focusing on safety first, then effectiveness.
- Participation involves regular hospital visits, blood tests, and bone marrow checks.
- Potential benefits include access to new treatment; risks include side effects.
- You can withdraw from the study at any time without penalty.
Who may be eligible?
To be considered for this study, you must be an adult aged 18 years or older. There is no upper age limit, meaning people of all adult ages are welcome to be considered.
The study is open to both men and women who have been diagnosed with acute myeloid leukemia (AML). Doctors will look at your overall health and your specific type of AML to see if this might be a suitable study for you.
It's important to know that simply having AML and being over 18 doesn't automatically mean you can join. There will be other specific health checks and requirements that your doctors will discuss with you to make sure the study is a safe and appropriate option.
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 Leukemia (AML)?
- Are you able to attend regular hospital visits for treatment and tests?
- Are you comfortable with blood tests and bone marrow samples?
What does participation involve?
If you decide to take part in this study, you will receive the new combination treatment of Liposomal Annamycin and cytarabine. This will likely involve receiving the medications through a drip (infusion) into your vein. You will have regular visits to the hospital or clinic to receive your treatment and to have various tests.
These tests will include blood samples taken frequently to check your blood counts and how your body is responding to the treatment. You will also have bone marrow samples taken, which involves taking a small sample of bone marrow to examine under a microscope. This helps doctors see how the cancer is reacting to the treatment.
The total duration of your participation in the study, including how many cycles of treatment you receive and how long the follow-up period is, will depend on your individual response to the treatment and the study plan. Your doctors will explain the full schedule to you in detail.
Potential risks and benefits
Locations (2)
- —UnverifiedPoland
- —UnverifiedItaly
Common questions
What is AML?
AML stands for Acute Myeloid Leukemia, which is a type of cancer that starts in the blood-forming cells of the bone marrow.
What does 'Phase 1/2' mean?
This means it's an early study; Phase 1 checks if the treatment is safe, and Phase 2 then looks at how well it works.
What is Liposomal Annamycin?
It's a new drug being tested for AML, specially packaged to potentially work better and have fewer side effects.
Will I get 'placebo' treatment?
No, in this study, all participants will receive the active treatment combination of Liposomal Annamycin and cytarabine.
Can I stop participating if I want to?
Yes, you have the right to leave the study at any time, and this will not affect your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.