At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Odronextamab (drug), Loncastuximab tesirine (drug), Rituximab (drug), Ifosfamide (drug)
- How long the study runs
- Study runs about 108 months (dates as stated)
- About the drug or intervention
- Odronextamab — drug: CD20xCD3 bispecific antibody · Loncastuximab tesirine — drug: CD-19-directed antibody-drug conjugate · Rituximab — drug: Modified R-ICE chemotherapy · Ifosfamide — drug: Modified R-ICE chemotherapy · Carboplatin — drug: Modified R-ICE chemotherapy · Etoposide — drug: Modified R-ICE chemotherapy · Etoposide Phosphate — drug: Modified R-ICE (Treatment Arm II) · Dexamethasone — drug: Modified R-ICE chemotherapy · CAR T-cells (TBC) — biological: Modified R-ICE chemotherapy
- Patient visit burden
- Not specified by the sponsor
In plain English
This is a global study testing new medicines in babies, children, teenagers and young adults (up to age 25) whose B-cell non-Hodgkin lymphoma (a cancer of the lymphatic system) has come back after treatment or has not responded to it. The study is funded by the University of Birmingham. It has two treatment groups, each with its own extra joining rules.
Who can take part
- Confirmed B-cell non-Hodgkin lymphoma diagnosed by tissue testing, such as diffuse large B-cell lymphoma, Burkitt lymphoma or similar types
- The lymphoma has come back after treatment (relapsed) or has not responded to treatment (refractory)
- At least one tumour that can be measured on a scan, or disease in the bone marrow or, for some treatment groups, in the nervous system only
- Age from birth to 25 years old
- Well enough day-to-day (performance score of at least 50) with a life expectancy of at least 8 weeks
- Blood, liver and (depending on treatment group) kidney function at levels set out in the study rules
- A negative pregnancy test for patients who can become pregnant, and agreement to use contraception during treatment and for 12 months after
- Written informed consent from the patient and/or a parent or legal representative
- Extra rules apply for each treatment group, for example about kidney function and recovery after cell therapies such as CAR T-cell therapy
Who may not be able to
- B-cell acute lymphoblastic leukaemia or B-cell lymphoblastic lymphoma
- Too soon after a stem cell transplant, cell therapy such as CAR T-cells, radiotherapy, other experimental treatment, or graft versus host disease (exact waiting times are set out in the study rules)
- Ongoing side effects from recent lymphoma treatment
- Known DNA repair disorder or primary immunodeficiency
- Pregnancy or breastfeeding
- Unable to attend regular follow-up visits or unlikely to stick to the study rules
- Uncontrolled infection at the time of joining
- Known HIV infection
- Hepatitis B carrier status, past infection or positive hepatitis B test results
- Live vaccine within 28 days before joining
- Known severe allergy to any of the study treatments or their ingredients
- Extra exclusions for treatment group I only include nervous-system-only disease, certain heart problems, CD20-negative disease, a seizure in the last 12 months, previous CD20 x CD3 bispecific therapy, and allergy to both allopurinol and rasburicase
- Extra exclusions for treatment group II only include fluid build-up needing drainage or causing breathlessness, and more than 7 days of steroid treatment in the 14 days before joining
What taking part involves
- • Receiving one of the study's new medicines, according to which of the two treatment groups the patient joins
- • Regular scans and tests, such as CT (computed tomography) or MRI (magnetic resonance imaging) scans, blood tests and bone marrow checks, to see how the disease responds
- • Regular hospital visits so the study team can check progress and side effects
- • Not stated — ask the trial team
Time commitment: Taking part involves hospital visits for treatment, scans and blood tests; how long the study lasts and how often visits happen are not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- Up to 25 Years
- Who
- All
- Number of participants
- 210
- Started
- 2024-05-02
- Last checked
- 2026-02
Plain English Summary
What is this study?
- • Testing a new treatment for b-cell non hodgkin lymphoma
- • Phase2/Phase3 - 210 participants
- • 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)
Who can take part?
- • Ages Up to 25 Years
- • Diagnosed with b-cell non hodgkin lymphoma
Where?
- • Birmingham - Birmingham Children's Hospital
- • Bristol - Bristol Royal Hospital for Children
- • Manchester - Royal Manchester Children's Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
Glo-BNHL is an adaptive prospective international multicentre platform clinical trial designed to evaluate the safety and efficacy of novel agents for the treatment of children, adolescents, and young adults with relapsed and/or refractory B-cell non-Hodgkin Lymphoma (r/r BNHL). The trial is designed to generate sufficient evidence to potentially be practice-changing in this rare cancer setting. With the trial incorporating an initial stage evaluating efficacy followed potentially by an expansion stage to provide confirmatory analysis, the trial could be considered to be phase II/III. Novel agents will be prioritised for inclusion in the platform according to an overarching prioritisation list and a robust systematic scientific assessment, performed by the international Trial Steering Committee (TSC). The platform consists of three parallel treatment arms, each one investigating a different novel agent in a group of patients. The platform allows the testing of a pipeline of novel agents in each treatment arm consecutively. Patients in the platform may be enrolled into any of the available treatment arms for which they are eligible. The classes of novel agents prioritised for inclusion at the initiation of the trial are: * Treatment Arm I: Bispecific antibodies (BsAbs) * Treatment Arm II: Antibody-drug conjugates (ADC) with standard chemotherapy * Treatment Arm III: Chimeric antigen receptor (CAR) T-cells The platform trial has an adaptive Bayesian design that facilitates efficient GO/NoGO decisions relevant to the target population enrolled in each treatment arm. The Bayesian approach estimates the probability that a novel agent is clinically effective and enables decision-making even with small numbers of patients. It can also incorporate prior knowledge, thereby maximising the utility of all available data in this rare population. It facilitates continuous evaluation of any novel agent as the sample size increases. Furthermore it allows for the discontinuation of an agent if the observed trial data demonstrate a high probability that the novel agent is ineffective at any time, allowing the next agent in the pipeline to be introduced. If the prioritisation of classes of novel agents by the TSC changes, treatment arms can be amended, added, or removed to reflect this. Not all Treatment Arms will necessarily be open to recruitment at all times.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: Up to 25 Years
- Who can join: All genders
Biomarkers mentioned
Who cannot take part
- ✗B-cell Acute Lymphoblastic Leukaemia (B-ALL)/B-cell Lymphoblastic Lymphoma (B-LBL)
- ✗Patients within:
- ✗90 days after an allogenic HSCT procedure
- ✗45 days after an autologous HSCT procedure
- ✗28 days of experiencing graft versus host disease (GvHD) requiring treatment that goes through your whole body, and/or immunosuppressive treatment
See the full criteria
Where Is This Study? (3 UK sites)
Birmingham Children's Hospital
Birmingham, United Kingdom
Bristol Royal Hospital for Children
Bristol, United Kingdom
Royal Manchester Children's Hospital
Manchester, United Kingdom
How to Get in Touch
Joseph Rogers
Sponsor contactCONTACT
Sarah Johnson
Sponsor contactCONTACT
