RecruitingPHASE1INTERVENTIONAL

A Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms

This research study is investigating a new medication called JNJ-90189892. It's for adults living with acute myeloid leukemia (AML) or specific types of myelodysplastic neoplasms (MDS) that have either come back or haven't responded to previous treatments. The study has different parts. Some parts look at JNJ-90189892 on its own, focusing on finding the best and safest dose. Other parts combine JNJ-90189892 with existing treatments, azacitadine and venetoclax, for both relapsed AML and newly diagnosed AML. The main goals are to determine how safe the new drug is, how well it's tolerated, and if it helps treat these blood cancers.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Janssen Research & Development, LLC

Enrolment target

155

Start

21 Mar 2025

Estimated completion

21 Nov 2028

Leukemia, Myeloid, Acute Myelodysplastic Neoplasms

What is this study about?

This study is looking into a new treatment called JNJ-90189892 for two types of blood cancer: acute myeloid leukemia (AML) and myelodysplastic neoplasms (MDS). AML is a fast-growing cancer of the blood and bone marrow, and MDS is a condition where the bone marrow doesn't produce enough healthy blood cells, often progressing to AML. Researchers want to see if JNJ-90189892 could be a helpful new option, especially for people whose cancer has returned or didn’t get better with other treatments.

The study is divided into several stages, often called 'parts'. In the first parts, the main goal is to find the right dosage of JNJ-90189892 that is safe and well-tolerated by patients when given on its own. Once the safest dose is found, later parts of the study will give more people that dose to confirm its safety and see how effective it is in treating their cancer. For some patients with AML, the study will also test JNJ-90189892 in combination with two other well-known cancer drugs, azacitadine and venetoclax, to see if working together makes them more effective.

Finding new, effective treatments for AML and MDS is very important because these conditions can be challenging to treat, especially when they come back or don't respond to standard therapies. This research aims to understand how JNJ-90189892 works, measure its possible benefits, and learn about any potential side effects, with the ultimate goal of improving outcomes for patients.

Key takeaways

This study is testing a new drug, JNJ-90189892, for AML and MDS.
It aims to find safe and effective doses, sometimes using it with other treatments.
The study includes adults with relapsed/refractory or newly diagnosed AML and certain MDS types.
Participants will have regular hospital visits for assessments.
Potential benefits include access to a new treatment; risks include unknown side effects.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you would need to meet certain requirements. You must be an adult, aged 18 or older, and weigh at least 40 kg (about 6 stone 4 pounds). Your doctor would also check your general health, including how active you are, and make sure your kidneys are working well based on specific tests.

For most parts of the study, you must have been diagnosed with acute myeloid leukemia (AML) or a specific type of higher-risk myelodysplastic neoplasms (MDS) that has come back or not responded to previous treatments. However, one part of the study is specifically for people who have been newly diagnosed with AML and haven't started treatment yet.

You wouldn't be able to join if you have certain health issues, such as severe lung problems needing extra oxygen, or an uncontrolled infection. Also, if you've had major surgery or a serious injury recently, or if you're allergic to the study drug JNJ-90189892 or the other drugs used in some parts of the study (azacitadine or venetoclax), you wouldn't be eligible. The study also cannot include individuals with certain other cancers or if the cancer has spread to the brain or spinal cord.

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 weigh at least 40 kg (about 6 stone 4 pounds)?
Have you been diagnosed with acute myeloid leukemia (AML) or a higher-risk type of myelodysplastic neoplasm (MDS)?
Is your AML relapsed, refractory, or newly diagnosed (for specific study parts)?
Do you have reasonably good general health, as determined by your doctor?
Do you have good kidney function, as indicated by a specific blood test?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the new study drug, JNJ-90189892, and possibly azacitadine and venetoclax, depending on which part of the study you join. You will need to attend regular appointments at the hospital. These appointments will involve various medical assessments to monitor your health, how the treatment is affecting you, and how your cancer is responding. This will include blood tests, physical examinations, and other procedures as required by the study plan.

The study will continue for a period, during which you'll receive the treatment and have follow-up visits. The exact duration will vary based on the study part and your individual response to treatment. For example, some parts will continue until the treatment is no longer beneficial or side effects become too strong. Even after you stop the study treatment, there will likely be follow-up appointments to track your long-term health. The medical team will explain the full schedule and what each visit entails if you are considering joining.

Potential risks and benefits

Taking part in a clinical trial offers the chance to receive a new, experimental treatment before it's widely available, which could potentially help your condition when other treatments haven't worked or are not suitable. Some people find comfort in contributing to medical knowledge that might help others in the future. However, new treatments can have side effects that are not yet fully known, and there's no guarantee that the treatment will be effective for you. You might experience side effects that range from mild to serious. It's very important to remember that participating in any clinical trial is entirely voluntary, and you have the right to withdraw at any time for any reason, without it affecting your usual medical care.

Locations (9)

Concord Hospital
Verified postcode
Concord, Australia· Recruiting
Peter MacCallum Cancer Centre
Verified postcode
Melbourne, Australia· Recruiting
Sir Charles Gairdner Hospital
Verified postcode
Nedlands, Australia· Recruiting
Institut Paoli-Calmettes
Verified postcode
Marseille, France· Recruiting
CHRU de Strasbourg - Hopital de Hautepierre
Verified postcode
Strasbourg, France· Recruiting
Institut Claudius Regaud
Verified postcode
Toulouse, France· Recruiting
Hosp Univ Fund Jimenez Diaz
Verified postcode
Madrid, Spain· Recruiting
Clinica Univ. de Navarra
Verified postcode
Pamplona, Spain· Recruiting
Hospital Universitario Virgen Rocio
Verified postcode
Seville, Spain· Recruiting

Common questions

What kind of blood cancers is this study for?

This study is for adults with acute myeloid leukemia (AML) or certain types of myelodysplastic neoplasms (MDS).

What is JNJ-90189892?

JNJ-90189892 is a new experimental drug being tested in this study to see if it can treat these blood cancers.

Will I receive other treatments in this study?

Some parts of the study will give JNJ-90189892 on its own, while other parts will combine it with two existing cancer drugs: azacitadine and venetoclax.

Why are there different 'parts' to the study?

The different parts help researchers first find the safest dose of the new drug and then test its effectiveness in more people, or test it in combination with other medicines.

What does 'relapsed or refractory' mean?

It means the cancer has come back after previous treatment, or it didn't respond to earlier treatments.

How to find out more

Study Contact

participate-in-this-study1@its.jnj.com 844-434-4210 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.