Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Phase 1b, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-64264681 in Combination with JNJ-67856633 in Participants with Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

This research study is for people who have non-Hodgkin lymphoma or chronic lymphocytic leukaemia. Doctors are testing a new combination of two medicines, JNJ-64264681 and JNJ-67856633. This is an early-stage study, meaning it's one of the first times these specific medicines are being used together in people. The main goals are to understand if the combination is safe, how the body handles the medicines, and if they start to show any positive effects. This type of study helps doctors learn more about potential new treatments for these blood cancers.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Janssen Cilag International

Enrolment target

Start

20 Aug 2024

non-Hodgkin lymphoma and chronic lymphocytic leukemia

What is this study about?

This study is looking into new ways to treat two types of blood cancer: non-Hodgkin lymphoma and chronic lymphocytic leukaemia. These are conditions where white blood cells don't work properly and grow out of control. Researchers are trying out a new combination of two medications, which for now are called JNJ-64264681 and JNJ-67856633. Think of it like trying a new recipe with two ingredients to see if they taste good and work well together.

This is a 'Phase 1b' study. This means it's an early step in testing new medicines. The main focus is to make sure the medicines are safe when given together and to understand how they behave in the body – for example, how long they stay in your system. We also want to see if they have any positive effects on the cancer. It's not about finding a cure at this stage, but more about gathering important information to decide if these medicines are promising enough to test further.

Knowing how new medicines work and if they are safe is a vital first step in developing better treatments for serious conditions like non-Hodgkin lymphoma and chronic lymphocytic leukaemia. Patients who join studies like this play a huge role in helping advance medical science for everyone.

Key takeaways

This study is testing two new medicines for non-Hodgkin lymphoma and chronic lymphocytic leukaemia.
It's an early-stage study focused on safety and how the medicines work in the body.
You will receive study medicines and have regular health check-ups.
Participation is voluntary, and you can withdraw at any time.
There might be potential benefits, but also potential risks like side effects.
This research helps doctors learn more about future treatments.

Who may be eligible?

To join this study, you must be at least 18 years old. Both men and women can take part. Because this is an early study, there will be other specific health requirements that your doctor will need to check carefully.

For example, you would need to have been diagnosed with either non-Hodgkin lymphoma or chronic lymphocytic leukaemia. There might also be rules about any previous treatments you’ve had or your overall health condition. These rules are put in place to ensure the study is as safe as possible for everyone involved and that the results are clear.

Your study doctor will look at all your medical information to see if this study is right for you. They will explain everything in detail if you are interested in 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 or older?
Do you have a diagnosis of non-Hodgkin lymphoma or chronic lymphocytic leukaemia?
Are you able to attend regular hospital/clinic visits?
Are you comfortable with taking new medications as part of a study?
Are you willing to have blood tests and other medical checks regularly?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the two study medicines, JNJ-64264681 and JNJ-67856633. These will be given according to a specific schedule decided by the study doctors. You will have regular visits to the hospital or clinic. During these visits, you’ll have various medical checks, which might include blood tests, physical exams, and possibly other scans or procedures to monitor your health and see how the medicines are working.

These checks help the doctors understand if the medicines are safe for you and if they are having any effect on your condition. The study will continue for a certain period, and even after you stop taking the study medication, you'll likely have follow-up visits to ensure your health is stable. The medical team will explain the full schedule of visits, tests, and medication doses before you make any decision.

Potential risks and benefits

Taking part in any medical study has both potential benefits and potential risks. A possible benefit of joining this study is that you might receive new medicines that are not yet widely available, which could potentially help your condition. However, because these medicines are still being tested, we don't fully know how helpful they will be, and they might not improve your health. As with all medicines, there is a risk of side effects, which the study doctors will monitor very closely. It's important to remember that joining this study is completely your choice, and you can withdraw at any time without needing to give a reason, and this will not affect your future medical care.

Locations (2)

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

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Unverified
Poland
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Unverified
Belgium

Common questions

What are non-Hodgkin lymphoma and chronic lymphocytic leukaemia?

These are types of cancer that start in white blood cells, which are part of your immune system. They affect how your body fights infection.

What does 'Phase 1b' mean?

It means this is an early study to check the safety of new medicines and how they work in the body, rather than how well they treat the disease at this stage.

Will I get better if I join this study?

We don’t know yet. While there's a chance the medicines could help, the main goal of this early study is to understand safety and how the medicines act in the body.

Will I have to pay to be in the study?

No, you will not have to pay for the study medicines or study-related medical visits.

Can I leave the study once I've started?

Yes, you can choose to leave the study at any time, for any reason. Your medical care will not be affected.