Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

Study of JNJ-74856665 in patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome

This research study is testing a new drug, JNJ-74856665, for people who have been diagnosed with a type of blood cancer called Acute Myeloid Leukaemia (AML) or a related condition called Myelodysplastic Syndrome (MDS). These conditions affect how your body makes blood cells. This is a very early stage of testing for this new medicine, often called a 'Phase I' study. The main goal at this stage is to check if the new drug is safe for people to take and to understand its effects on the body. This helps doctors learn the best way to give the medicine in the future. The study is open to both men and women aged 18 and over.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Janssen Cilag International

Enrolment target

Start

26 Jul 2024

Acute myeloid leukemia or Myelodysplastic syndrome

What is this study about?

This study is investigating a new medicine, known for now as JNJ-74856665. It's designed for people who have certain blood conditions: Acute Myeloid Leukaemia (AML) or Myelodysplastic Syndrome (MDS). AML is a cancer that starts in the bone marrow, the soft tissue inside your bones where blood cells are made. It causes the body to produce abnormal white blood cells. MDS is a condition where the bone marrow doesn't make enough healthy blood cells. Both conditions can be serious and affect your body's ability to fight infection, carry oxygen, and stop bleeding.

This particular study is in its very first stage of human testing, often called 'Phase I'. At this early point, researchers are mainly focused on safety. They want to find out if the new medicine is well-tolerated by the human body and to understand how it behaves once it’s in your system. This includes looking at how much of the drug gets into your blood, how long it stays there, and how your body processes it. This information is crucial for deciding the right dosage and treatment plan for future studies.

The reason studies like this are important is to find new and potentially better ways to treat serious conditions like AML and MDS. Current treatments can be effective, but there's always a need for more options, especially for those whose conditions haven't responded well to existing therapies. By taking part in this early study, you could help researchers gather vital information that could lead to new treatments being available for many more patients in the future.

Key takeaways

It's a study for a new medicine (JNJ-74856665) for AML or MDS.
This is an early-stage (Phase I) study, mainly focused on safety.
Open to adults aged 18 and over, both men and women.
Requires frequent clinic visits and close monitoring.
There are potential benefits and risks, as with any new treatment.
You can stop participating at any time without affecting your care.

Who may be eligible?

To join this study, you must be at least 18 years old. There's no upper age limit, meaning older adults are also welcome to take part. The study is open to both men and women.

Crucially, you would need to have a confirmed diagnosis of either Acute Myeloid Leukaemia (AML) or Myelodysplastic Syndrome (MDS). The study will have other health requirements that your doctor will need to check to make sure it's safe for you to participate. These usually involve checking your overall health, how well your organs are working, and any other medical conditions you might have.

There will also be reasons why someone might not be able to join, such as having certain other serious health problems, or already being on specific treatments that could interfere with the new study medicine. Your doctor will carefully review all your medical information to see if this study is a good fit 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 diagnosed with Acute Myeloid Leukaemia (AML)?
Have you been diagnosed with Myelodysplastic Syndrome (MDS)?
Are you willing to attend regular hospital visits for check-ups?
Are you comfortable with the idea of taking an experimental medicine?
Are you able to follow study instructions carefully?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be given the new study medicine, JNJ-74856665. Since this is an early-stage study, you can expect frequent visits to the clinic, especially at the beginning. These visits will involve various tests and assessments to monitor your health and how your body is reacting to the medicine. This could include blood tests, urine tests, physical check-ups, and possibly other scans or procedures.

The study will last for a certain period, which your doctor will explain. After you stop taking the study medicine, there will likely be follow-up visits or phone calls to continue monitoring your health for some time. The total duration of your involvement, from your first visit to your final follow-up, will be clearly explained to you by the study team.

Potential risks and benefits

Taking part in a clinical trial like this could offer potential benefits, such as receiving a new medicine that isn't widely available yet, which might help your condition. You will also receive very close medical attention and monitoring from a dedicated team. However, as with any new medicine, there are potential risks. The experimental drug might cause side effects, some of which could be serious, and it might not improve your condition. Researchers are constantly monitoring for these and will tell you about any known or expected 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
Spain

Common questions

What is Acute Myeloid Leukaemia (AML) or Myelodysplastic Syndrome (MDS)?

Both are serious conditions affecting how your body makes blood cells in the bone marrow. AML is a type of blood cancer, while MDS means your bone marrow isn't making enough healthy blood cells.

What does 'Phase I' study mean?

It's the very first time a new medicine is tested in people. The main aim is to check if it's safe and to understand how it works in the body, rather than how effective it is as a treatment.

Will I get help with travel costs if I join?

It's common for studies to offer help with travel or other expenses, but you'll need to ask the study team directly for details specific to this trial.

What if the new medicine doesn't work for me?

If the medicine isn't helping or causes difficult side effects, the study doctors will stop the trial medicine and help you return to, or find, the best standard care for you.

Will I know if I'm getting the actual medicine or a dummy pill (placebo)?

In this early Phase I study, it's very likely that everyone will receive the new medicine. Placebos are more common in later stages of research. The study team will explain exactly what treatment arm you are on.