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B-cell Non Hodgkin LymphomaPhase 2/3Glo-BNHLNCT05991388

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

A Phase 2/3 study testing Odronextamab, Loncastuximab tesirine and Rituximab in people with B-cell Non Hodgkin Lymphoma, run by University of Birmingham at 11 sites in 7 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages Up to 25 years
Conditions the study is for
B-cell Non Hodgkin Lymphoma
What is being tested?
Odronextamab, Loncastuximab tesirine and Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
11 sitesin 7 countries
Study dates
2 May 2024to 1 May 2033
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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);
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  • 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
  • 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
  • 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.

Who cannot join

  • 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
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  • 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
  • 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
  • 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

Trial locations and contacts

11 sites in 7 countries. Contact the study team or a site near you to ask about taking part.

Joseph Rogers contact

+44 (0)121 414 8040

glo-BNHL@trials.bham.ac.uk

Sarah Johnson contact

+44 (0)121 414 8040

glo-BNHL@trials.bham.ac.uk

11 sites in 7 countries

Australia3 sites, 3 recruiting

  • Queensland Children's Hospital

    Brisbane, Queensland

    Morag Whyte

    Morag Whyte

    Not yet recruiting

  • Perth Children's Hospital

    Perth, Washington

    Michelle Ng

    Michelle Ng

    Recruiting

  • The Children's Hospital at Westmead

    Sydney, New South Wales

    Caroline Bateman

    Caroline Bateman

    Not yet recruiting

Other trials in Australia

United Kingdom3 sites, 3 recruiting

  • Birmingham Children's Hospital

    Birmingham

    Amos Burke

    Amos Burke

    Recruiting

  • Bristol Royal Hospital for Children

    Bristol

    Emma Seaford

    Emma Seaford

    Recruiting

  • Royal Manchester Children's Hospital

    Manchester

    Guy Makin

    Guy Makin

    Recruiting

Other trials in United Kingdom

Austria1 site, 1 recruiting

  • St. Anna Children's Hospital

    Vienna

    Andishe Attarbaschi

    Andishe Attarbaschi

    Recruiting

Other trials in Austria

Belgium1 site, 1 recruiting

  • UZ Leuven

    Leuven

    Anne Uyttebroeck

    Anne Uyttebroeck

    Not yet recruiting

Other trials in Belgium

Netherlands1 site, 1 recruiting

  • Princess Máxima Centre for Pediatric Oncology

    Utrecht

    Erica Brivio

    Erica Brivio

    Recruiting

Other trials in Netherlands

New Zealand1 site, 1 recruiting

  • Starship Children's Hospital

    Auckland

    Tim Prestidge

    Tim Prestidge

    Not yet recruiting

Other trials in New Zealand

Sweden1 site, 1 recruiting

  • Sahlgrenska University Hospital

    Gothenburg

    Karin Mellgren

    Karin Mellgren

    Not yet recruiting

Other trials in Sweden

About this study

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.

Read more

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.

Read the detailed description

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.

Being tested
Odronextamab, Loncastuximab tesirine, Rituximab, Ifosfamide, Carboplatin
Medical subject headings
Lymphoma, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OdronextamabDrug

    Also called REGN-1979

    CD20xCD3 bispecific antibody

  • Loncastuximab tesirineDrug

    Also called ADCT-402

    CD-19-directed antibody-drug conjugate

  • RituximabDrug

    Modified R-ICE chemotherapy

  • IfosfamideDrug

    Modified R-ICE chemotherapy

  • CarboplatinDrug

    Modified R-ICE chemotherapy

  • EtoposideDrug

    Modified R-ICE chemotherapy

  • Etoposide PhosphateDrug

    Modified R-ICE (Treatment Arm II)

  • DexamethasoneDrug

    Modified R-ICE chemotherapy

  • CAR T-cells (TBC)Biological

    Modified R-ICE chemotherapy

Study groups in NCT05991388
Study groupRoleWhat they receive
Treatment Arm I - BsAb - OdronextamabExperimentalPatients will receive odronextamab given as an intravenous infusion weekly for 12 weeks, then every two weeks until nine months, and every four weeks thereafter until progression or for a maximum of two years
Receives: Drug: Odronextamab
Treatment Arm II - ADC with Standard Chemotherapy - Loncastuximab tesirine with modified R-ICEExperimentalPatients will receive loncastuximab tesirine given as a 30-minute intravenous infusion with each cycle of modified R-ICE (maximum three cycles)
Receives: Drug: Loncastuximab tesirine; Drug: Rituximab; Drug: Ifosfamide; Drug: Carboplatin; Drug: Etoposide; Drug: Etoposide Phosphate; Drug: Dexamethasone
Treatment Arm III - CAR T-cells - TBCExperimentalPatients will receive CAR-T cell therapy - agent TBC
Receives: Biological: CAR T-cells (TBC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment Arm I: BsAb: Occurrence of an objective response (OR)

    Occurrence of an objective response (OR) i.e. Complete Response (CR) or Partial Response (PR) after 12 weeks of treatment assessed by Independent Central Review (according to International Paediatric Non-Hodgkin Lymphoma Response Criteria)

    Measured: At the end of week 12 of treatment

  2. Treatment Arm II: ADC with standard chemotherapy: Occurrence of CR

    Occurrence of CR within a maximum of three cycles of treatment assessed by Independent Central Review (according to International Paediatric Non-Hodgkin Lymphoma Response Criteria)

    Measured: At the end of Cycle 2 and Cycle 3 of treatment (each cycle is 28 days)

Secondary outcomes (8)

  1. Event-free survival time (EFS)

    All treatment arms

    Measured: From start of treatment until last patient has been followed up for 2 years

  2. Progression-free survival time (PFS)

    All treatment arms

    Measured: From start of treatment until last patient has been followed up for 2 years

  3. Overall survival time (OS)

    All treatment arms

    Measured: From start of treatment until last patient has been followed up for 2 years

  4. Best overall response (BOR) during treatment

    All treatment arms

    Measured: At the end of weeks 4, 8, and 12 for Treatment Arm I; at the end of cycles 1, 2, and 3 for Treatment Arm II (each cycle is 28 days)

  5. Duration of response (DOR)

    All treatment arms

    Measured: From start of treatment until last patient has been followed up for 2 years

  6. Occurrence of an objective response (OR), where relevant

    Treatment arm specific

    Measured: At the end of cycles 1, 2, and 3 (each cycle is 28 days)

  7. Occurrence of adverse events of special interest (AESI)

    Treatment arm specific

    Measured: From start of treatment until 90 days after last day of treatment

  8. Occurrence of treatment emergent adverse events (TEAEs), where relevant

    Treatment arm specific

    Measured: From start of treatment until 90 days after last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2023
  2. Study start2 May 2024
  3. Primary completion1 May 2031 (estimated)
  4. Study completion1 May 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Platform trial
Masking
None (open label)
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05991388
Sponsor's protocol ID
RG_21-124
Other IDs
ITCC-100, 1004701
Acronym
Glo-BNHL
Status last verified
Feb 2026
First submitted
24 Jul 2023
Last updated
20 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Odronextamab, Loncastuximab tesirine and Rituximab in people with B-cell Non Hodgkin Lymphoma, run by University of Birmingham at 11 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 35 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Australia, United Kingdom, Austria, Belgium, Netherlands and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Joseph Rogers (+44 (0)121 414 8040, glo-BNHL@trials.bham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Arm I: BsAb: Occurrence of an objective response (OR) (time frame: At the end of week 12 of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05991388.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.

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