Phase II study on Venetoclax (VEN) plus Decitabine (DEC) (VEN-DEC) for elderly (≥60 <75years) patients with newly diagnosed Acute Myeloid Leukemia (AML) elegible for allogeneic Stem Cell Transplantation (allo-SCT)
This study, called a Phase II trial, is testing a new combination of medicines, Venetoclax and Decitabine, for people aged 60 to 74 who have recently been diagnosed with Acute Myeloid Leukemia (AML). AML is a type of cancer that affects the blood and bone marrow. The main goal of this study is to see how many patients treated with this "chemo-free" combination can then go on to have a stem cell transplant. A stem cell transplant, also known as a bone marrow transplant, can offer a chance of a cure for AML. Researchers want to understand if this new treatment helps patients reach a state where a transplant becomes a safe and effective option.
At a glance
What is this study about?
This clinical trial is designed for older adults, specifically those aged between 60 and 74, who have recently been diagnosed with Acute Myeloid Leukemia, often shortened to AML. AML is a serious blood cancer that affects the white blood cells in your bone marrow. For many people with AML, a stem cell transplant (sometimes called a bone marrow transplant) offers the best chance of a long-term cure. However, getting to the point where you're healthy enough for a transplant can be challenging, especially for older patients.
This study is investigating a new way to prepare patients for a stem cell transplant. Instead of traditional chemotherapy, which can be very harsh, this trial uses a combination of two drugs, Venetoclax and Decitabine. These drugs work differently from standard chemotherapy and are sometimes called a "chemo-free" combination in this context. The main purpose of the study is to see how many patients treated with this newer combination can successfully go on to receive a stem cell transplant after their AML is brought under control.
Researchers will also be carefully tracking other important things. This includes how well the drug combination works to control the AML, what happens after the stem cell transplant (like how the new cells settle in and whether there are any complications), and how long patients stay healthy without the cancer returning. The study also looks at the overall health and well-being of patients in the years following their treatment.
Key takeaways
- This study is for older people (60-74) with newly diagnosed AML.
- It tests a new drug combination to help patients get a stem cell transplant.
- The treatment is different from traditional chemotherapy.
- Researchers will check how well the drugs work and patient health after transplant.
- It's a Phase II study, continuing to assess effectiveness and safety.
Who may be eligible?
To join this study, you would generally need to be an adult aged between 60 and 74 years old who has recently found out they have Acute Myeloid Leukemia (AML). The study is specifically looking for people who, based on their health, might be suitable candidates for a stem cell transplant. This means your doctors would need to assess whether you're well enough to potentially receive this type of transplant.
Both men and women can take part. While the main focus is on the older age group, the study also indicates that people from 18 years upwards could potentially be considered. However, the detailed information stresses the 60-74 age range for newly diagnosed AML patients who are eligible for a stem cell transplant.
- Are you between 60 and 74 years old?
- Have you recently been diagnosed with Acute Myeloid Leukemia (AML)?
- Have your doctors said that a stem cell transplant might be an option for you?
- Are you able to attend regular hospital appointments?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would receive the new treatment combination of Venetoclax (given as an infusion) and Decitabine (taken as tablets). You would have regular appointments at the hospital for treatments, check-ups, and tests to monitor your health and how the treatment is working. This would involve blood tests, bone marrow checks, and potentially scans. If the treatment works well and your doctors believe you are ready, you would then proceed with a stem cell transplant. After the transplant, there would be follow-up appointments over several years to monitor your recovery, check for any side effects, and ensure the cancer has not returned. The total duration of your participation would depend on your individual treatment plan and follow-up schedule.
Potential risks and benefits
Locations (1)
- —Italy
Common questions
What is AML?
AML stands for Acute Myeloid Leukemia, which is a fast-growing cancer of the blood and bone marrow. It affects the production of healthy blood cells.
What is a stem cell transplant?
A stem cell transplant (also known as a bone marrow transplant) is a medical procedure that replaces unhealthy blood-forming cells with healthy ones, often from a donor. It can offer a cure for some blood cancers like AML.
What does 'chemo-free' mean in this study?
In this study, 'chemo-free' means the treatment combination of Venetoclax and Decitabine works differently from traditional, very strong chemotherapy drugs. It's intended to be a different approach to preparing patients for a transplant.
What phase is this study?
This is a Phase II study. This means researchers are looking more closely at how well the new treatment works and continue to monitor its safety in a larger group of patients.
Will I still get my usual care if I don't join or leave the study?
Yes, absolutely. Your decision about joining or leaving the study will not affect the standard medical care you receive for your condition.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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