Magrolimab plus intensive chemotherapy in newly diagnosed “ELN intermediate or poor-risk” AML patients intended to undergo allogeneic stem cell transplantation, a Phase 2, Single-arm, Open-Label Study (MAGROLIC)
This study, called MAGROLIC, is for adults with a type of blood cancer called Acute Myeloid Leukemia (AML) that has been recently diagnosed and is considered to be higher-risk. Participants are those who are planning to have a stem cell transplant as part of their treatment. The study is investigating a new drug called Magrolimab, given alongside standard chemotherapy. Its main goal is to find out if this combination successfully puts the AML into remission after one or two rounds of treatment. Researchers will also be looking at how long people live, how long they stay free of the disease, and their overall quality of life during and after treatment. This is a Phase 2 study, meaning it's exploring how safe and effective the new treatment is.
At a glance
What is this study about?
This study is looking into a new treatment approach for adults who have recently been diagnosed with a type of blood cancer called Acute Myeloid Leukemia, often shortened to AML. This particular study focuses on people whose AML is considered to be 'higher-risk' and who are also planning to receive a stem cell transplant. The treatment being tested involves a new medicine called Magrolimab given together with standard chemotherapy drugs.
The main purpose of this study is to see how effective this new combination therapy is at getting the AML into remission. Remission means that signs and symptoms of the cancer are greatly reduced or disappear. Researchers want to know if one or two cycles of this treatment can successfully bring about remission. They will also be closely watching other important factors, such as how long people stay healthy after treatment, their overall survival, and how the treatment affects their daily lives and well-being.
By gathering this information, doctors hope to understand if this new combination of Magrolimab and chemotherapy could be a helpful and effective option for patients with newly diagnosed, higher-risk AML who are preparing for a stem cell transplant. This research aims to find better ways to treat this challenging condition.
Key takeaways
- This study combines a new drug, Magrolimab, with standard chemotherapy for AML.
- It's for adults with newly diagnosed, higher-risk AML who are planning a stem cell transplant.
- The main goal is to see how effectively the treatment puts AML into remission.
- Researchers will also track survival, disease-free time, and quality of life.
- You can stop participating at any time without affecting your medical care.
Who may be eligible?
To be considered for this study, you would need to be an adult, aged 18 or older.
Your recent diagnosis of Acute Myeloid Leukemia (AML) must be classified as 'intermediate or poor-risk' by specific medical guidelines. You also need to be a candidate for an allogeneic stem cell transplant, which is a transplant using stem cells from a donor.
Both men and women can take part in this study. There will be other specific medical criteria that your doctor will check to ensure the study is safe and suitable for you.
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 recently diagnosed with Acute Myeloid Leukemia (AML)?
- Is your AML considered 'intermediate or poor-risk'?
- Are you a candidate for an allogeneic (donor) stem cell transplant?
What does participation involve?
If you decide to take part in this study, you would receive the new drug, Magrolimab, in combination with standard chemotherapy. The chemotherapy drugs might include Cytarabine, a combination drug called Vyxeos, or Daunorubicin, depending on what your doctors decide is best for your specific case. These treatments would be given in cycles.
Throughout the study, you would have regular appointments for various assessments. These include blood tests, bone marrow biopsies, and check-ups to monitor your health and how you are responding to the treatment. Doctors will also carefully track any side effects you might experience. You will also be asked to complete questionnaires to understand how the treatment is affecting your quality of life. The exact number of visits and tests would be discussed in detail by your study doctor.
Potential risks and benefits
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Common questions
What is AML?
AML stands for Acute Myeloid Leukemia. It's a type of cancer that starts in the blood-forming cells of the bone marrow.
What is Magrolimab?
Magrolimab is a new experimental drug being tested in this study. It's designed to work with chemotherapy to fight the cancer cells.
What does 'remission' mean?
Remission means that the signs and symptoms of your cancer have decreased significantly or disappeared. It doesn't always mean the cancer is cured, but it's a very positive step.
What is a stem cell transplant?
An allogeneic stem cell transplant is a medical procedure where healthy blood-forming cells from a donor are given to you to help replace your own diseased cells.
Why is quality of life being measured?
Beyond how well the treatment fights the cancer, it's also very important to understand how it affects your daily well-being, energy, and overall feeling, which is why quality of life is being looked at.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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