All studies
RecruitingPHASE2, PHASE3INTERVENTIONAL

A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-cell Non-Hodgkin Lymphoma

This study, called Glo-BNHL, is searching for improved treatments for children and young people with B-cell non-Hodgkin Lymphoma (B-NHL) that hasn't responded to initial therapy (refractory) or has come back (relapsed). B-NHL is a type of cancer that affects immune cells and can appear in different parts of the body. Current treatments are often harsh with significant side effects, and only work for a small number of patients. The trial will divide participants into three groups, each receiving a new medicine, sometimes combined with standard chemotherapy. Researchers will carefully check if these new medicines are safe and if they help treat the cancer. The study is designed to quickly find and focus on the most promising new treatments to give young patients better options.

At a glance

Status
Recruiting
Phase
PHASE2, PHASE3
Sponsor
University of Birmingham
Enrolment target
210
Start
02 May 2024
Estimated completion
01 May 2033

What is this study about?

The Glo-BNHL trial is an important research study focused on finding new and better medicines for children and young people who have B-cell non-Hodgkin Lymphoma (B-NHL). This is a type of cancer that affects specific immune cells in the body. When B-NHL doesn't respond to initial treatments or comes back after treatment, it's called 'refractory' or 'relapsed' B-NHL. This can be very challenging to treat, and the medications currently available are very strong, often causing difficult side effects, and unfortunately, they only work for a small number of patients.

This study aims to change that by testing several new medicines. Participants will be organised into three different groups, and each group will receive a new medicine, sometimes alongside standard chemotherapy. The main goal is to see if these new medicines are safe to use in children and young people, and more importantly, if they are effective at treating the cancer. The research team, made up of experts from around the world, will be carefully monitoring the progress of these medicines. If a medicine isn't showing positive results, it will be quickly removed from the study, making way for potentially more effective treatments to be tested.

The trial is designed to be very flexible, meaning that if one new medicine isn't working for a child, they might be able to try a different new medicine in another group. This approach helps researchers learn efficiently and quickly identify the most promising treatments. Children and young people from across the globe are invited to take part, and once their treatment in the trial is finished, they will be carefully monitored for at least two years to keep an eye on any potential long-term effects of the new medicines.

Key takeaways

  • This study evaluates new treatments for B-cell non-Hodgkin Lymphoma (B-NHL) that has returned or not responded to prior therapy.
  • It aims to find safer and more effective medicines for children and young people.
  • Participants will receive one of several new medicines, sometimes combined with chemotherapy.
  • The study uses a flexible design to quickly identify the most promising treatments.
  • Global experts are involved in selecting and monitoring the treatments.
  • Participants will be followed for at least two years after treatment to monitor long-term effects.

Who may be eligible?

This study is looking for children and young people up to 25 years old who have B-cell non-Hodgkin Lymphoma (B-NHL). This includes specific types like Burkitt Lymphoma or Diffuse Large B-Cell Lymphoma that have been confirmed by a doctor.

To join, your B-NHL must either be in its first relapse (meaning it's come back after one previous treatment), in a later relapse (come back after more than one previous treatment), or be refractory (meaning previous treatments haven't worked). The doctors will need to see clear signs of the cancer through scans or other tests. You also need to be generally well enough to take part, with good enough health in your blood, liver, and kidneys, as assessed by the study doctors.

There are also some other specific medical details considered for each new medicine being tested, so it's always best to discuss your situation with your doctor to see if this study could be an option for you.

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. Do you have B-cell non-Hodgkin Lymphoma (B-NHL)?
  2. Are you 25 years old or younger?
  3. Has your B-NHL come back after treatment, or hasn't it responded to previous treatment?
  4. Are you generally well enough, with good blood, liver, and kidney health?
  5. Do scans or tests show clear signs of the cancer?
Answer every question to see your result.

What does participation involve?

If you join this study, you'll be part of one of three groups, each testing a different new medicine, sometimes alongside chemotherapy. The number of visits and assessments will depend on the specific treatment you receive, but you can expect regular check-ups, blood tests, and scans to monitor your health and how the treatment is working. You will receive the study medication as prescribed by the research team.

The total duration of taking the study medication will vary, but once your treatment phase is complete, you will be followed up by the research team for at least two years. This follow-up involves regular check-ins to monitor your health and look for any potential long-term side effects from the new treatments. The study team will provide you with a detailed schedule of visits and what to expect throughout your participation.

Potential risks and benefits

Taking part in this study offers the potential to receive a new and innovative treatment that might be more effective than current options for B-NHL, especially if previous treatments haven't worked. However, like all medical treatments, these new medicines may have side effects, which the research team will carefully monitor. The study is designed to be flexible, allowing for quick changes if a treatment isn't working or safe. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (11)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • The Children's Hospital at Westmead
    Verified postcode
    Sydney, Australia· Not yet recruiting
  • Queensland Children's Hospital
    Verified postcode
    Brisbane, Australia· Not yet recruiting
  • Perth Children's Hospital
    Verified postcode
    Perth, Australia· Recruiting
  • St. Anna Children's Hospital
    Verified postcode
    Vienna, Austria· Recruiting
  • UZ Leuven
    Verified postcode
    Leuven, Belgium· Not yet recruiting
  • Princess Máxima Centre for Pediatric Oncology
    Verified postcode
    Utrecht, Netherlands· Recruiting
  • Starship Children's Hospital
    Verified postcode
    Auckland, New Zealand· Not yet recruiting
  • Sahlgrenska University Hospital
    Verified postcode
    Gothenburg, Sweden· Not yet recruiting
  • Birmingham Children's Hospital
    Verified postcode
    Birmingham, United Kingdom· Recruiting
  • Bristol Royal Hospital for Children
    Verified postcode
    Bristol, United Kingdom· Recruiting
  • Royal Manchester Children's Hospital
    Verified postcode
    Manchester, United Kingdom· Recruiting

Common questions

What is B-cell non-Hodgkin Lymphoma (B-NHL)?

It's a type of cancer that starts in certain immune cells called B-cells. These cells are found in your lymph nodes and other parts of your body.

What does 'relapsed' or 'refractory' mean?

'Relapsed' means the cancer has come back after treatment. 'Refractory' means the cancer did not respond to previous treatments.

Are the new medicines safe?

All new medicines are carefully tested, and the study will closely monitor for any side effects to make sure they are as safe as possible for patients.

Can I try a different medicine if one doesn't work?

Yes, if the medicine in your group doesn't work, you might be able to switch to a different group to try another new medicine within the study.

How long will I be involved in the study?

After your treatment in the trial, you'll be followed up for at least two years to monitor your health and any effects of the new medicine.

How to find out more

Joseph Rogers

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

Interested in taking part?

Register your interest

Share your details and the research team for "A Global Study of Novel Agents in Paediatric and Adolescent …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.