Active not recruitingPHASE1INTERVENTIONAL

A Study of JNJ-89853413 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms

This research study is looking into a new treatment called JNJ-89853413 for adults in the UK living with Acute Myeloid Leukemia (AML) or Myelodysplastic Neoplasms (MDS). These are types of blood cancer that have either come back or stopped responding to standard treatments. The study has two main parts. The first part focuses on finding a safe and tolerable dose of the new drug, carefully increasing it to see what works best. The second part will then look more closely at how safe and effective this drug is at those recommended doses. The goal is to develop better treatment options for these serious conditions.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Janssen Research & Development, LLC

Enrolment target

Start

14 Jan 2025

Estimated completion

12 Jan 2028

Leukemia, Myeloid, Acute Myelodysplastic Neoplasms

What is this study about?

This study is exploring a new medicine called JNJ-89853413. It's designed for adults who have specific types of blood cancer: Acute Myeloid Leukemia (AML) or Myelodysplastic Neoplasms (MDS). These are conditions where the body makes too many or not enough of certain types of blood cells. For individuals invited to take part in this study, their cancer has either returned after previous treatment, or it hasn't responded as expected to those initial treatments. This is often referred to as 'relapsed or refractory' cancer.

The study is being carried out in two main parts. The first part is like a careful exploration, where doctors give small amounts of the new medicine and slowly increase the dose. Their main goal here is to find the safest dose of JNJ-89853413 and to understand any side effects people might experience. This step is crucial for making sure the drug can be given as safely as possible.

Once a safe and appropriate dose has been identified, the study moves into its second part. Here, more people will receive the new medicine at the recommended dose. The focus will then be on observing both the safety of the drug further and how effective it is in treating the cancer. The hope is that this new medicine could offer a new treatment option for people with these specific types of blood cancer.

Key takeaways

This study is for adults with specific types of blood cancer (AML or MDS) that haven't responded to previous treatments.
It's testing a new drug called JNJ-89853413 to see if it's safe and effective.
The study has two parts: first to find a safe dose, then to look at how well it works.
Participation involves regular clinic visits for monitoring and assessments.
You can stop participating at any time if you change your mind.

Who may be eligible?

To join this study, people must have a confirmed diagnosis, according to expert guidelines, of either Acute Myeloid Leukemia (AML) or Myelodysplastic Neoplasms (MDS) that has come back or hasn't responded to previous treatments. For MDS, it needs to be a higher-risk type. Participants must also be at least 18 years old and weigh at least 40 kilograms (about 6 stone 4 pounds).

There are also some health requirements. Participants need to be generally well enough to take part, as assessed by their doctor, and have healthy kidney function. Blood tests will be done to make sure other body functions are within appropriate limits for the study. Participants shouldn't need extra oxygen to breathe and shouldn't have active infections that aren't under control.

People would not be able to join if they have had major surgery or a serious injury in the last two weeks, have cancer that has spread to their brain or spinal cord, or have known allergies to any ingredients in the study drug. These checks are important to ensure the safety of everyone taking 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 Acute Myeloid Leukemia (AML) that has returned or not responded to treatment?
Do you have a diagnosis of higher-risk Myelodysplastic Neoplasms (MDS) that has returned or not responded to treatment?
Do you weigh at least 40 kg (about 6 stone 4 pounds)?
Are you generally well enough to take part in a study, as assessed by a doctor?
Do you *not* currently need extra oxygen for breathing?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study drug, JNJ-89853413. The study will involve regular visits to the clinic for medical check-ups, blood tests, and other assessments to monitor your health and how you are responding to the treatment. This helps the study doctors understand the drug's effects and any potential side effects. These visits will be more frequent at the start of the study. The total duration of your participation will depend on how you respond to the treatment, but study treatments and follow-up can continue for some time.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to a new treatment before it's widely available, and contributing to medical knowledge that could help others in the future. However, there are also potential risks—the new drug might cause side effects, which could range from mild to serious and currently aren't fully known. Your health will be closely monitored throughout the study. Remember, participation is completely voluntary; you can withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (9)

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

Arthur J E Child Comprehensive Cancer Centre
Verified postcode
Calgary, Canada
Vancouver General Hospital
Verified postcode
Vancouver, Canada
Princess Margaret Hospital
Verified postcode
Toronto, Canada
Hosp Clinic de Barcelona
Verified postcode
Barcelona, Spain
Hosp Univ Fund Jimenez Diaz
Verified postcode
Madrid, Spain
Clinica Univ. de Navarra
Verified postcode
Pamplona, Spain
Addenbrookes Hospital
Verified postcode
Cambridge, United Kingdom
University College London Hospitals
Verified postcode
London, United Kingdom
The Christie NHS Foundation Trust Christie Hospital
Verified postcode
Manchester, United Kingdom

Common questions

What is AML or MDS?

AML (Acute Myeloid Leukemia) and MDS (Myelodysplastic Neoplasms) are types of blood cancer where there are problems with how blood cells are made in the bone marrow.

What does 'relapsed or refractory' mean?

It means the cancer has either returned after you've had treatment, or it hasn't responded well to the treatments you've received.

Is JNJ-89853413 approved for general use?

No, JNJ-89853413 is an investigational drug, meaning it's still being studied and is not yet approved for general use.

Will I receive the new drug or a placebo?

In this specific study, all participants will receive the investigational drug JNJ-89853413, as the primary goal is to assess its safety and effectiveness.

How long will the study last for an individual?

The length of time you would be on the study treatment can vary, depending on how you respond and whether you experience any side effects. It will be discussed in detail with the study team.