A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-cell Non-Hodgkin Lymphoma
Glo-BNHL
3 other identifiers
interventional
210
6 countries
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2024
Longer than P75 for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2023
CompletedFirst Posted
Study publicly available on registry
August 14, 2023
CompletedStudy Start
First participant enrolled
May 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2033
February 20, 2026
February 1, 2026
7 years
July 24, 2023
February 18, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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)
At the end of week 12 of treatment
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)
At the end of Cycle 2 and Cycle 3 of treatment (each cycle is 28 days)
Secondary Outcomes (8)
Event-free survival time (EFS)
From start of treatment until last patient has been followed up for 2 years
Progression-free survival time (PFS)
From start of treatment until last patient has been followed up for 2 years
Overall survival time (OS)
From start of treatment until last patient has been followed up for 2 years
Best overall response (BOR) during treatment
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)
Duration of response (DOR)
From start of treatment until last patient has been followed up for 2 years
- +3 more secondary outcomes
Study Arms (3)
Treatment Arm I - BsAb - Odronextamab
EXPERIMENTALPatients 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
Treatment Arm II - ADC with Standard Chemotherapy - Loncastuximab tesirine with modified R-ICE
EXPERIMENTALPatients will receive loncastuximab tesirine given as a 30-minute intravenous infusion with each cycle of modified R-ICE (maximum three cycles)
Treatment Arm III - CAR T-cells - TBC
EXPERIMENTALPatients will receive CAR-T cell therapy - agent TBC
Interventions
Modified R-ICE (Treatment Arm II)
CD20xCD3 bispecific antibody
CD-19-directed antibody-drug conjugate
Modified R-ICE chemotherapy
Modified R-ICE chemotherapy
Modified R-ICE chemotherapy
Modified R-ICE chemotherapy
Modified R-ICE chemotherapy
Eligibility Criteria
You may qualify if:
- 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:
- +20 more criteria
You may not qualify if:
- B-cell Acute Lymphoblastic Leukaemia (B-ALL)/B-cell Lymphoblastic Lymphoma (B-LBL)
- Patients within:
- days after an allogenic HSCT procedure
- days after an autologous HSCT procedure
- days of experiencing graft versus host disease (GvHD) requiring systemic therapy, and/or immunosuppressive treatment
- days of previous investigational treatment
- 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
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Birminghamlead
- Cancer Research UKcollaborator
- Fight Kids Cancercollaborator
- Regeneron Pharmaceuticalscollaborator
- ADC Therapeutics S.A.collaborator
Study Sites (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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amos Burke
University of Birmingham
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2023
First Posted
August 14, 2023
Study Start
May 2, 2024
Primary Completion (Estimated)
May 1, 2031
Study Completion (Estimated)
May 1, 2033
Last Updated
February 20, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share