All studies
Active not recruitingPHASE1INTERVENTIONAL

A Study of JNJ-90009530 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (r/r B-NHL)

This research study is investigating a new medication called JNJ-90009530 for people with a specific type of blood cancer called B-cell non-Hodgkin lymphoma. This is for patients whose cancer has either returned after previous treatments or has not responded to those treatments. It's an early-stage study, meaning it's one of the first times this treatment is being tested in people. The scientists want to find out what dose of JNJ-90009530 is safe and causes the fewest side effects. They also want to see if the new medicine can help shrink the cancer or stop it from growing, and for how long any benefits might last. The study is for adults aged 18 and over.

At a glance

Status
Active not recruiting
Phase
PHASE1
Sponsor
Janssen Research & Development, LLC
Enrolment target
21
Start
06 Nov 2023
Estimated completion
03 Jan 2040

What is this study about?

This research project is focused on finding a new way to treat B-cell non-Hodgkin lymphoma, which is a cancer that starts in certain white blood cells. Specifically, it's for people whose lymphoma has either come back after past treatments or hasn't responded well to the treatments they've already received. The new treatment being tested is a medication called JNJ-90009530.

This kind of study, called a Phase 1 study, is an early step in testing new medicines. Doctors want to be very careful to make sure any new treatment is safe. So, one of the main aims here is to find the right amount of JNJ-90009530 that patients can take without too many side effects. They'll also be closely watching to see how patients react to the medicine and if it helps their lymphoma.

The hope is that JNJ-90009530 could offer a new option for patients whose cancer is proving difficult to treat with current therapies. By carefully studying how it works and what effects it has, researchers aim to develop a new and effective treatment that could improve the lives of people with this type of lymphoma.

Key takeaways

  • This study is testing a new medicine for B-cell non-Hodgkin lymphoma.
  • It's for people whose lymphoma has come back or not responded to previous treatments.
  • The main goals are to find a safe dose and see how well the medicine works.
  • You must be 18 or older to join.
  • Participation involves close monitoring by doctors.
  • You can stop taking part at any time.

Who may be eligible?

To be able to take part in this study, you must be at least 18 years old. Your B-cell non-Hodgkin lymphoma must have come back after previous treatments or not responded well to them. If you have an aggressive type of large B-cell lymphoma or a specific type of follicular lymphoma (Grade 3b), you generally need to have had at least two different types of treatment before, including certain strong chemotherapy and a medicine called an anti-CD20 agent. If you have other types of follicular lymphoma (Grade 1-3a) or marginal zone lymphoma, you'll need to have had at least two previous cancer treatments, including an anti-CD20 medicine.

Also, your cancer cells must have a specific marker called CD20 on their surface, and your cancer must be 'measurable', meaning doctors can clearly see and track its size. Your general health and how well you can do daily activities will also be checked to make sure you're well enough for the study.

There are also some reasons why you might not be able to join. For example, if you have certain other conditions like certain types of herpes virus, uncontrolled infections, or had a recent stroke, heart problems, or a history of specific blood clots. If you've had a type of stem cell transplant recently, or have certain brain or nerve conditions, you might also not be able to participate. The study team will review all your medical history to see if it's safe for you to take 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.

  1. Are you 18 years old or older?
  2. Has your B-cell non-Hodgkin lymphoma come back or not responded to previous treatments?
  3. Have you had at least two different cancer treatments for your lymphoma (for most types)?
  4. Does your lymphoma have the CD20 marker?
  5. Are you generally well enough to take part in a study?
  6. Do you have any major health conditions that might prevent you from joining (like recent heart problems or uncontrolled infections)?
Answer every question to see your result.

What does participation involve?

Details about what taking part involves are not fully described in the brief summary. However, generally in an early-stage study like this, you would likely have regular visits to the hospital for doctors to monitor your health and check how the treatment is working. This would involve repeat blood tests, scans, and physical examinations. You would receive the study medication, JNJ-90009530, as directed by the study doctors. The frequency of visits and tests, and the total length of time you'd be in the study, will be fully explained by the study team. Usually, there's also a follow-up period after you stop taking the treatment to see how you're doing long-term.

Potential risks and benefits

Taking part in a study like this might offer a potential benefit if the new treatment helps your lymphoma, especially if other treatments haven't worked well for you. However, as this is a new medicine, there could be risks of side effects that are not yet fully known. The study will aim to find out what these are and how to manage them. All possible side effects will be explained to you in detail. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (15)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University of Iowa Hospital
    Verified postcode
    Iowa City, United States
  • University of Kentucky
    Verified postcode
    Lexington, United States
  • Mayo Clinic Rochester
    Verified postcode
    Rochester, United States
  • Rutgers University
    Verified postcode
    New Brunswick, United States
  • University Hospitals Cleveland Medical Center
    Verified postcode
    Cleveland, United States
  • University of Pennsylvania
    Verified postcode
    Philadelphia, United States
  • MD Anderson Cancer Center
    Verified postcode
    Houston, United States
  • Royal Prince Alfred Hospital
    Verified postcode
    Camperdown, Australia
  • Monash Medical Centre
    Verified postcode
    Clayton, Australia
  • Austin Hospital
    Verified postcode
    Heidelberg, Australia
  • Royal Brisbane and Women's Hospital
    Verified postcode
    Herston, Australia
  • Westmead Hospital
    Verified postcode
    Westmead, Australia

Common questions

What is B-cell non-Hodgkin lymphoma?

It's a type of cancer that starts in the B-lymphocytes, which are white blood cells that help your body fight infection.

What does 'relapsed or refractory' mean?

It means your lymphoma has either come back after treatment, or it hasn't responded to the treatments you've received.

What is JNJ-90009530?

It's a new medicine being tested in this study to see if it can help treat B-cell non-Hodgkin lymphoma.

What does a 'Phase 1' study mean?

It's an early stage of testing a new medicine in people. The main goals are to find a safe dose and look for any serious side effects.

Will I definitely get the new treatment?

Yes, in this type of study, all participants who meet the criteria would receive the investigational treatment JNJ-90009530.

How to find out more

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

Discussion

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