Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Phase 1, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-64264681 in Participants with Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

This research study is testing a new medicine, called JNJ-64264681, for people who have specific types of blood cancer: non-Hodgkin lymphoma or chronic lymphocytic leukaemia. This is a "Phase 1" study, which means it's one of the first times this medicine is being given to people. The main goals are to carefully check if the medicine is safe, to understand how the body uses and processes it, and to see what effects it has on the body. We call this "pharmacokinetics" and "pharmacodynamics." Participants would be adults aged 18 or older. Studies like this are vital steps in developing new treatments for serious illnesses.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Janssen Cilag International

Enrolment target

Start

09 Jul 2024

non-Hodgkin lymphoma and chronic lymphocytic leukemia

What is this study about?

This study is looking at a brand new medicine called JNJ-64264681. It's designed for people who have two specific types of blood cancer: non-Hodgkin lymphoma or chronic lymphocytic leukaemia. You might hear this medicine described as an "investigational drug" because it hasn't been approved for general use yet. Researchers need to test it carefully to make sure it's safe and to understand how it works.

This is a very early-stage study, often called a "Phase 1" study. In Phase 1 studies, the main focus is on safety. Doctors will also be keen to see how the new medicine moves through your body – how quickly it's absorbed, how long it stays, and how your body gets rid of it. This is called 'pharmacokinetics.' They will also look at 'pharmacodynamics,' which means what the medicine actually does inside your body.

Studies like this are a very important part of finding new and better treatments for many conditions, including cancer. While early studies mostly focus on safety, the information gathered helps doctors decide if a medicine is promising enough to be studied further in larger groups of people. It's how medical science progresses, step by step, to improve patient care.

Key takeaways

This study is for a new medicine called JNJ-64264681.
It's for people with non-Hodgkin lymphoma or chronic lymphocytic leukaemia.
It's a Phase 1 study, mainly focused on checking medicine safety.
Participants must be 18 years or older.
Both men and women can take part.

Who may be eligible?

To be able to join this study, people need to be at least 18 years old – there's no upper age limit. Both men and women can take part.

The study is specifically for individuals who have been diagnosed with either non-Hodgkin lymphoma or chronic lymphocytic leukaemia. These are both types of cancer that affect the blood and lymph system.

There will be other important rules about who can and cannot join, which a study doctor will explain in detail. These rules help make sure the study is safe for everyone involved and that the results are clear. For example, they might look at your general health, other medicines you are taking, and how your specific cancer has progressed.

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 non-Hodgkin lymphoma?
Do you have a diagnosis of chronic lymphocytic leukaemia?
Are you able to attend regular appointments and tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the new medicine, JNJ-64264681. Because this is a new medicine, the study team will need to see you regularly for check-ups. These visits will involve various assessments, such as blood tests, physical examinations, and possibly other scans or tests, to closely monitor your health and how your body is reacting to the medicine. The visits also help the doctors understand how the medicine is working and whether there are any side effects. You'll also have follow-up appointments after you stop taking the medicine to ensure your well-being. The total length of your participation in the study, including treatment and follow-up, will be fully explained to you before you make any decisions.

Potential risks and benefits

Participating in a study like this could mean you receive a new medicine that might help your condition, but it's important to remember this is not guaranteed, especially in early-stage studies. Potential risks include side effects from the new medicine, which are not fully known yet, as well as the time and effort involved in attending appointments and undergoing tests. You will be closely monitored, and 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
Poland

Common questions

What is a 'Phase 1' study?

A Phase 1 study is the first step in testing a new medicine in people. The main goal is to find out if it's safe, how much can be given, and how the body handles it.

What are non-Hodgkin lymphoma and chronic lymphocytic leukaemia?

These are both types of cancer that affect special white blood cells called lymphocytes, which are part of your body's immune system.

Will I definitely get the new medicine?

Yes, in this specific study, participants will receive the investigational medicine, JNJ-64264681.

How long will I be in the study?

The exact duration for each person will be explained by the study team, typically including a period of taking the medicine and then follow-up checks.

What if I change my mind after joining?

You can leave the study at any time, for any reason, without it affecting your regular medical care.