RecruitingPhase 2Phase 3NCT05991388

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


Sponsor

University of Birmingham

Enrollment

210 participants

Start Date

May 2, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The Glo-BNHL trial is trying to find better medicines for children and young people with B-cell non-Hodgkin Lymphoma (B-NHL) that does not go away (refractory B-NHL) or does but comes back again (relapsed B-NHL). B-NHL is a type of cancer that develops inside or outside of lymph nodes (glands) and organs such as the liver or spleen. Examples of B-NHL are Burkitt Lymphoma and Diffuse Large B Cell Lymphoma, which may be other names used to describe this type of cancer. It is very difficult to cure relapsed or refractory B-NHL. The medicines used now are very powerful with many side effects and only cure around 30 in every 100 children treated. It is very important that investigators quickly find better medicines for these children and young people. The Glo-BNHL trial will include three groups of children and young people, each given a new medicine (either alone or with chemotherapy). The investigators are looking to make sure the new medicines are safe and that they work to treat the cancer. If the medicine in one group does not work for a child in the trial, then they may be able to join a different group to have another new medicine. Experts from around the world will carefully pick the medicines most likely to be helpful to be part of the trial. If one of the new medicines seems not to be working as well as hoped then the investigators will take it out of the trial as soon as possible. This will let other new medicines be added to the trial and tested. If a medicine does seem to be working well, then it will continue in the trial to make sure it really is the most useful medicine available. Children from around the world will be invited to take part in the trial. The investigators will then check on them for at least two years after they finish the trial treatment to look for possible side effects of the new medicine.


Eligibility

Max Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This global study is testing new treatments for children and teenagers whose B-cell non-Hodgkin lymphoma (a type of blood cancer) has come back or stopped responding to treatment. It evaluates several novel drug combinations. **You may be eligible if...** - You are a child or adolescent with a confirmed diagnosis of mature B-cell non-Hodgkin lymphoma (such as Burkitt lymphoma or large B-cell lymphoma) - Your cancer has relapsed (come back) or is refractory (not responding to treatment) - You have received at least one prior line of therapy **You may NOT be eligible if...** - You are an adult (18 or older) - You have a different type of lymphoma not covered by the study - Your overall health does not meet the study's safety requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOdronextamab

CD20xCD3 bispecific antibody

DRUGLoncastuximab tesirine

CD-19-directed antibody-drug conjugate

DRUGRituximab

Modified R-ICE chemotherapy

DRUGIfosfamide

Modified R-ICE chemotherapy

DRUGCarboplatin

Modified R-ICE chemotherapy

DRUGEtoposide

Modified R-ICE chemotherapy

DRUGEtoposide Phosphate

Modified R-ICE (Treatment Arm II)

DRUGDexamethasone

Modified R-ICE chemotherapy

BIOLOGICALCAR T-cells (TBC)

Modified R-ICE chemotherapy


Locations(11)

The Children's Hospital at Westmead

Sydney, New South Wales, Australia

Queensland Children's Hospital

Brisbane, Queensland, Australia

Perth Children's Hospital

Perth, Washington, Australia

St. Anna Children's Hospital

Vienna, Austria

UZ Leuven

Leuven, Belgium

Princess Máxima Centre for Pediatric Oncology

Utrecht, Netherlands

Starship Children's Hospital

Auckland, New Zealand

Sahlgrenska University Hospital

Gothenburg, Sweden

Birmingham Children's Hospital

Birmingham, United Kingdom

Bristol Royal Hospital for Children

Bristol, United Kingdom

Royal Manchester Children's Hospital

Manchester, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05991388


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