Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Phase 1b study to evaluate MK 0482 for Relapsed/Refractory AML/CMML

This is an early research study, known as a Phase 1b trial, focused on a new medicine called MK 0482. It's for adults (18 years and older) who have acute myeloid leukaemia (AML) or chronic myelomonocytic leukaemia (CMML). These are types of blood cancer. The study is specifically for people whose cancer has either returned after previous treatment or hasn't responded as hoped. Researchers want to understand if MK 0482 is safe to use and how it affects the body. It's a key first step in testing a new treatment, helping doctors decide if it's worth studying in more detail for these conditions.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

05 Jul 2023

Active CNS leukemia.

What is this study about?

This research is looking at a new potential medicine called MK 0482. It's being tested in adults who have specific types of blood cancer: acute myeloid leukaemia (AML) or chronic myelomonocytic leukaemia (CMML). Sometimes, these cancers can be difficult to treat, and they might come back after treatment or not respond as well as doctors would like. This study is for people in that situation.

Because this is an early-stage study (called a Phase 1b trial), the main goals are to find out if the new medicine is safe to use and how it acts in the body. Researchers will be looking carefully at any side effects and how the body handles the medicine. This helps them understand the best way to give the medicine and whether it has potential to help people with these cancers.

Developing new treatments is a long process, and studies like this one are a crucial first step. If the medicine is found to be safe and shows some promise, it could then be studied in larger groups of people to see if it's an effective treatment for AML or CMML. This study is important for learning more about new ways to fight these specific blood cancers.

Key takeaways

This is an early research study for a new medicine, MK 0482.
It's for adults with specific blood cancers (AML or CMML) that have come back or not responded well.
The main aim is to check the medicine's safety and how it works in the body.
Participation means regular hospital visits for tests and to receive the medicine.
There's a chance to try a new treatment, but no guarantee of personal benefit.
You can stop participating at any point without affecting your care.

Who may be eligible?

This study is for adults aged 18 or over. It's open to both men and women. You would generally be considered if you have a specific type of blood cancer called acute myeloid leukaemia (AML) or chronic myelomonocytic leukaemia (CMML).

Doctors are particularly looking for people whose cancer has either come back after previous treatments or hasn't responded well to those treatments. However, there's one important condition that would mean you couldn't join the study: if your cancer has spread to your brain or spinal cord directly (doctors call this "active CNS leukaemia").

Other specific medical details will be checked by the study doctors to make sure the study is a safe and appropriate option for you. They’ll look at your overall health and previous treatments to decide if you can take part.

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 AML or CMML?
Has your cancer come back or not responded well to previous treatments?
Do you NOT have active leukaemia in your brain or spinal cord?
Are you able to travel to study appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would likely have a number of visits to the hospital or clinic. During these visits, doctors and nurses would perform various checks. This might include blood tests, physical examinations, and other tests to monitor your health and how the new medicine, MK 0482, is affecting you.

You would be given the study medicine according to a specific plan designed by the researchers. This could involve taking a pill or having an injection or infusion, depending on how the medicine is designed. The study team will explain exactly how and when you'll receive the medicine.

There will also be follow-up appointments after you finish taking the medicine to continue monitoring your health, looking for any long-term effects. The total length of your participation would be explained to you in detail by the study team before you decide to join.

Potential risks and benefits

Taking part in any medical study has potential benefits and potential risks. The potential benefit of taking part in this early-stage study is the chance to try a new medicine that might help your specific condition, especially if other treatments haven't worked or are no longer an option. However, as this is an experimental medicine, there's no guarantee it will help you, and it might not improve your health. As with all medicines, there's a risk of side effects, which could be mild or more serious, and the study team will monitor you closely for these. 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
Spain

Common questions

What is AML or CMML?

AML (acute myeloid leukaemia) and CMML (chronic myelomonocytic leukaemia) are types of cancer that affect the blood and bone marrow, which is the spongy part inside your bones where blood cells are made.

What does 'relapsed/refractory' mean?

It means the cancer has either returned after being treated previously (relapsed) or it hasn't responded well to earlier treatments (refractory).

What is a 'Phase 1b study'?

This is an early stage of research where doctors are mainly focused on finding out if a new medicine is safe and how it behaves in the body, rather than how well it treats the disease.

Will I get the new medicine?

Yes, if you join this study, everyone will receive the new medicine called MK 0482. This study isn't comparing it to a placebo or another treatment.

Who is running this study?

This study is being conducted by researchers to test the new medicine, MK 0482. The details of the specific organisations involved would be provided by your doctor or the study team.