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Looking for participantsPhase2/Phase3

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

Sponsor: University of Birmingham

NCT ID: NCT05991388

View on ClinicalTrials.gov ↗

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.

B-cell Non Hodgkin Lymphoma

How this trial compares with your answers

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What we know so far

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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

Virus or positiveantibody positiveCD20CD20 negativeCD3

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
Inclusion criteria applicable to all treatment arms: * Histologically proven mature B-NHL (Diffuse Large B-Cell Lymphoma (DLBCL), Burkitt Lymphoma/Leukaemia or atypical Burkitt/Burkitt-like lymphoma, primary mediastinal large B-cell lymphoma (PMLBL), and mature B-NHL/Not Otherwise Specified (NOS)) at initial diagnosis * Radiologically and/or histologically proven B-NHL in first relapse (only one prior line of therapy) or subsequent relapse (more than one prior line of therapy) or refractory(\*) B-NHL. (Note: relapses following prior targeted therapy must have continuing target positivity, confirmed by an established method). * If relapse occurs more than two years after previous therapy, a biopsy must be performed * Evaluable disease as per the international paediatric non-Hodgkin Lymphoma response criteria, including: * at least one bi-dimensionally measurable nodal lesion \>1.5 cm in its longest dimension; * or at least one bi-dimensionally measurable extra-nodal lesion \>1.0 cm in its longest dimension on computerised tomography (CT) or Magnetic Resonance Imaging (MRI); * or bone marrow involvement (≥25% involvement from bone marrow, if only site of disease. Any standard method of assessment is acceptable i.e. cytomorphology, flow cytometry and/or immunohistochemistry); * or, dependent on treatment arm, evaluable Central Nervous System (CNS) only disease (evaluable by imaging or Cerebrospinal Fluid (CSF) analysis)(\*\*) * Age from birth to ≤25 years old at the time of trial entry * Performance status ≥50 using Karnofsky or Lansky performance scores * Life expectancy of ≥8 weeks * Adequate bone marrow function documented by: * Platelet count ≥50x 10\^9/L (no platelet transfusion therapy within seven days prior to treatment) unless bone marrow involvement(\*\*\*) * Absolute neutrophil count (ANC) ≥0.75 x 10\^9/L (no granulocyte colony stimulating factor within 2 days prior to treatment) unless bone marrow involvement(\*\*\*) * Adequate hepatic function documented by: * Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤5 x upper limit of normal (ULN) * Total bilirubin ≤1.5 X ULN \*\*\*Patients with known Gilbert syndrome will be excluded if the total bilirubin value is \>4 x ULN for the local general population * Documented negative pregnancy test for female patients of childbearing potential within seven days prior to trial entry * Patients of reproductive potential agrees to use effective contraception whilst on trial treatment and for 12 months following treatment discontinuation * Written informed consent given by patient and/or parents/legal representative Inclusion criteria applicable to treatment arm I only: * Male patients of reproductive potential must agree not to donate sperm whilst on trial treatment and for 6 months following treatment discontinuation * Adequate renal function, creatinine clearance \>45 ml/min by measurement or estimation (if creatinine levels are normal for the patient's age, using the Cockroft-Gault Equation is sufficient) * For patients with bone marrow involvement(\*\*\*) or splenic sequestration, adequate bone marrow function documented by: * Platelet count ≥25 x 10\^9/L (no platelet transfusion therapy within three days prior to treatment) * Haemoglobin level ≥7 g/dL * Absolute neutrophil count (ANC) ≥0.5 x 10\^9/L (no granulocyte colony stimulating factor within two days prior to treatment) * Patients who have received CAR T-cell therapy or other cellular therapies more than 28 days prior must demonstrate recovery from acute toxicities and have measurable disease Inclusion criteria applicable to treatment arm II only: * Adequate renal function, by measured glomerular filtration rate (GFR) \>60 ml/min/1.73m\^2 (estimated GFR is not sufficient) * For patients with bone marrow involvement(\*\*\*) or splenic sequestration, requirements for bone marrow function do not apply (\*) Refractory disease The following patients are considered to have refractory disease and can be included in this trial: * Patients with who do not achieve PR or CR with last therapy * Patients with partial response to last therapy (biopsy proven), with no evidence of progression (\*\*) CNS only disease Patients with CNS only disease may be eligible depending on the treatment arm. Please refer to the relevant treatment arm specific eligibility criteria. (\*\*\*) Bone marrow involvement Patients who have ≥ 25% blasts in the bone marrow are considered to have bone marrow involvement. For these patients, requirements for bone marrow function are dependent on treatment arm. Please refer to the relevant treatment arm specific eligibility criteria. Exclusion Criteria: * 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 systemic therapy, and/or immunosuppressive treatment * 14 days of previous investigational treatment * 28 days of receiving craniospinal radiation; or 14 days of any other radiation * For patients who have received any CAR T-cell therapy or other cellular therapies, see treatment arm specific eligibility criteria * Patients who have ongoing acute toxicities from most recent lymphoma directed therapy * Patients with known DNA repair disorder or known primary immunodeficiency * Patients who are pregnant or breastfeeding (exclusively or partially) * Patients who cannot regularly be followed up in accordance with the protocol due to psychological, social, geographical or other issues * Patients for whom non-compliance with treatment or trial procedures is expected * Uncontrolled concomitant infection. Severe infection (such as sepsis, pneumonia, etc.) should be clinically controlled at the time of trial entry * Known HIV positivity * Hepatitis B carrier status, history of Hepatitis B Virus or positive serology. A patient is considered as a Hepatitis B Virus carrier or to have (had) Hepatitis B Virus infection in case of: * Unimmunized and HBsAg and/or anti-HBs antibody and/or anti- HBc antibody positive, * Immunized and HBsAg and/or anti-HBc antibody positive. * Live vaccine within 28 days prior to trial entry * Known history of hypersensitivity to any of the treatments or excipients Exclusion criteria applicable to treatment arm I only: * Central Nervous System (CNS) only disease * Patients within 28 days of any CAR-T cell therapy or other cellular therapies * Left ventricular shortening fraction (LVSF) \<27% or left ventricular ejection fraction (LVEF) \<50%, as determined by ECHO or MUGA, any evidence of pericardial effusion (except trace or physiological) as determined by an ECHO, and any clinically significant arrhythmias * Known CD20 negative disease at initial diagnosis * Seizure within the last 12 months * Prior treatment with CD20 x CD3 bispecific therapy * Known hypersensitivity to both allopurinol and rasburicase Exclusion criteria applicable to treatment arm II only: * Patients within 42 days of any CAR-T cell therapy or other cellular therapies * Clinically significant (Grade ≥2) third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath) * Steroid treatment for more than a total of seven days in the 14 days prior to trial entry

Where Is This Study? (3 UK sites)

Birmingham Children's Hospital

Birmingham, United Kingdom

Recruiting
Site contact (verified)
Amos BurkePrincipal Investigator

Bristol Royal Hospital for Children

Bristol, United Kingdom

Recruiting
Site contact (verified)
Emma SeafordPrincipal Investigator

Royal Manchester Children's Hospital

Manchester, United Kingdom

Recruiting
Site contact (verified)
Guy MakinPrincipal Investigator

How to Get in Touch

Joseph Rogers

Sponsor contact

CONTACT

+44 (0)121 414 8040 glo-BNHL@trials.bham.ac.uk

Sarah Johnson

Sponsor contact

CONTACT

+44 (0)121 414 8040 glo-BNHL@trials.bham.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2026-02