Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Precision therapy versus standard therapy in Acute Myeloid Leukaemia and Myelodysplastic syndrome in elderly (PALM) – a phase II randomized clinical trial

This research study, called PALM, is for older individuals diagnosed with specific types of blood cancer, including Acute Myeloid Leukaemia (AML), Myelodysplastic Syndrome (MDS), or Chronic Myelomonocyte Leukaemia. It aims to see if newer, 'precision' treatments, which are tailored more to a person's specific cancer, are more effective and better value for money than the usual treatments. The study is particularly interested in how these treatments affect a person's quality of life, alongside their medical outcomes. By carefully comparing different medicines like Dacogen, Nexavar, or Venclyxto, the researchers hope to find the best ways to treat these conditions for future patients in the UK.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Akershus University Hospital

Enrolment target

Start

18 Oct 2024

Chronic myelomonocyte leukemia Myelodysplastic syndrome Acute myeloid leukemia

What is this study about?

Imagine your body as a complex machine. Sometimes, parts of this machine, like the blood-forming cells in your bone marrow, start to go wrong. This can lead to certain types of blood cancer, such as Acute Myeloid Leukaemia (AML), Myelodysplastic Syndrome (MDS), and Chronic Myelomonocyte Leukaemia.

Traditionally, treatments for these cancers are given to many people. This study, called PALM, is exploring what are known as 'precision' treatments. These are newer approaches that try to match the treatment more closely to the specific features of an individual's cancer. The main goal is to measure if these special treatments not only work well but also provide good value for money, especially when we think about how they improve a person's quality of life. The study aims to compare these precision treatments with the standard treatments currently used.

By taking part, you would help doctors understand if these newer, more tailored treatments offer a better way forward for people in the future. They will look at how your health-related quality of life changes, and the overall costs involved in your treatment and follow-up care, to help make decisions about the best approaches for the NHS.

Key takeaways

Compares new 'precision' treatments with standard care for blood cancers.
Aims to improve treatment for Acute Myeloid Leukaemia, Myelodysplastic Syndrome, and Chronic Myelomonocyte Leukaemia.
Focuses on older patients, but open to all adult ages.
Investigates not only effectiveness but also cost-effectiveness and quality of life.
May involve treatments like Dacogen, Nexavar, or Venclyxto.

Who may be eligible?

This study is open to both men and women, and there are no specific age limits, meaning adults of all ages, including older individuals, may be considered.

The study is specifically looking for people who have been diagnosed with certain types of blood cancer: Acute Myeloid Leukaemia (AML), Myelodysplastic Syndrome (MDS), or Chronic Myelomonocyte Leukaemia. The medical team will review your specific diagnosis to see if it matches what they are looking for.

Before you can join, the study doctors will need to check your general health and your specific cancer details to make sure the study is a safe and suitable option 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.

Have you been diagnosed with Acute Myeloid Leukaemia (AML)?
Do you have Myelodysplastic Syndrome (MDS)?
Have you been diagnosed with Chronic Myelomonocyte Leukaemia?
Are you an adult of any age?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either a 'precision' therapy or a standard treatment, which would be decided randomly (like flipping a coin). The treatments might involve different medicines that you take as tablets or receive as an injection or infusion (a drip).

Throughout the study, you would have regular visits to the hospital or clinic to monitor your health, check how you are responding to the treatment, and ensure your safety. These visits would include physical exams, blood tests, and possibly other tests to check your quality of life. The total duration of your participation would depend on your specific treatment plan and how you respond, but would include follow-up appointments after your main treatment concludes.

Potential risks and benefits

Participating in this study might offer you access to new treatments that are not yet widely available. There's a chance these 'precision' therapies could work better for you than standard treatments, potentially improving your health and quality of life. However, like all medicines, the treatments in this study can have side effects, and they might not work for everyone. The study team will explain all known side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Norway

Common questions

What is 'precision therapy'?

Precision therapy means treatment that's specifically chosen to target features unique to your cancer, rather than a one-size-fits-all approach.

Will I definitely get a new treatment?

You will be randomly assigned to either receive one of the new 'precision' treatments or a standard treatment already used for your condition.

How long will the study last for me?

The length of your participation will depend on your individual treatment plan and how your health progresses, but it will include follow-up monitoring.

Does this study involve surgery?

No, this study focuses on drug treatments given as tablets, injections, or infusions, not surgery.

What does 'quality of life' mean in this study?

It means how well you feel and function in your daily life while undergoing treatment, and how that is measured and valued.