Actively Recruiting

Phase 2
Phase 3
Age: 0 - 25Years
All Genders
NCT05991388

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

Led by University of Birmingham · Updated on 2026-02-20

210

Participants Needed

11

Research Sites

469 weeks

Total Duration

On this page

Sponsors

U

University of Birmingham

Lead Sponsor

C

Cancer Research UK

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 0 - 25Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed mature B-cell non-Hodgkin lymphoma at initial diagnosis
  • Radiologically or histologically confirmed first or subsequent relapse or refractory B-NHL
  • Biopsy required if relapse occurs more than two years after previous therapy
  • Disease measurable by imaging or bone marrow involvement as per criteria
  • Age from birth to 25 years at trial entry
  • Performance status 50 or above using Karnofsky or Lansky scores
  • Life expectancy of at least 8 weeks
  • Adequate bone marrow and liver function according to specified lab values
  • Negative pregnancy test for females of childbearing potential within 7 days before trial entry
  • Agreement to use effective contraception during treatment and for 12 months after
  • Written informed consent given by patient and/or legal representative
  • For treatment arm I: males agree not to donate sperm during treatment and 6 months after
  • Specific renal function and bone marrow function requirements for treatment arms I and II
  • Recovery and measurable disease required for patients previously treated with CAR T-cell or cellular therapies
Not Eligible

You will not qualify if you...

  • Diagnosis of B-cell Acute Lymphoblastic Leukemia or B-cell Lymphoblastic Lymphoma
  • Recent allogenic or autologous stem cell transplant within specified time frames
  • Recent graft versus host disease requiring therapy
  • Previous investigational treatment or radiation within specified days before trial
  • Ongoing acute toxicities from prior lymphoma therapy
  • Known DNA repair disorder or primary immunodeficiency
  • Pregnancy or breastfeeding
  • Inability to comply with follow-up due to psychological, social, or geographic reasons
  • Expected non-compliance with treatment or trial procedures
  • Uncontrolled or severe infection
  • Known HIV positivity or hepatitis B carrier or history
  • Live vaccine within 28 days prior to trial entry
  • Known hypersensitivity to treatments or excipients
  • Specific exclusions for treatment arm I including CNS only disease, recent CAR T-cell therapy, cardiac function limits, CD20 negative disease, seizures, and prior CD20xCD3 bispecific therapy
  • Specific exclusions for treatment arm II including recent CAR T-cell therapy, significant third space fluid accumulation, and recent steroid treatment over 7 days

AI-Screening

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Trial Site Locations

Total: 11 locations

1

The Children's Hospital at Westmead

Sydney, New South Wales, Australia

Not Yet Recruiting

2

Queensland Children's Hospital

Brisbane, Queensland, Australia

Not Yet Recruiting

3

Perth Children's Hospital

Perth, Washington, Australia

Actively Recruiting

4

St. Anna Children's Hospital

Vienna, Austria

Actively Recruiting

5

UZ Leuven

Leuven, Belgium

Not Yet Recruiting

6

Princess Máxima Centre for Pediatric Oncology

Utrecht, Netherlands

Actively Recruiting

7

Starship Children's Hospital

Auckland, New Zealand

Not Yet Recruiting

8

Sahlgrenska University Hospital

Gothenburg, Sweden

Not Yet Recruiting

9

Birmingham Children's Hospital

Birmingham, United Kingdom

Actively Recruiting

10

Bristol Royal Hospital for Children

Bristol, United Kingdom

Actively Recruiting

11

Royal Manchester Children's Hospital

Manchester, United Kingdom

Actively Recruiting

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Research Team

J

Joseph Rogers

CONTACT

S

Sarah Johnson

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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