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RECRUITING
NCT05991388
PHASE2/PHASE3

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

Sponsor: University of Birmingham

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

Any - 25 Years

Study Type

INTERVENTIONAL

Enrollment

210

Start Date

2024-05-02

Completion Date

2033-05-01

Last Updated

2026-02-20

Healthy Volunteers

No

Interventions

DRUG

Odronextamab

CD20xCD3 bispecific antibody

DRUG

Loncastuximab tesirine

CD-19-directed antibody-drug conjugate

DRUG

Rituximab

Modified R-ICE chemotherapy

DRUG

Ifosfamide

Modified R-ICE chemotherapy

DRUG

Carboplatin

Modified R-ICE chemotherapy

DRUG

Etoposide

Modified R-ICE chemotherapy

DRUG

Etoposide Phosphate

Modified R-ICE (Treatment Arm II)

DRUG

Dexamethasone

Modified R-ICE chemotherapy

BIOLOGICAL

CAR 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