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

Sponsor
University of Birmingham
Study ID
NCT05991388
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • B-cell Non Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
N/A - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
May 2, 2024
Status verified
Feb 2026
Primary completion
May 1, 2031
Completion
May 1, 2033

Study Design

Enrollment
210 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm I - BsAb - Odronextamab
    Patients 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
  • Experimental: Treatment Arm II - ADC with Standard Chemotherapy - Loncastuximab tesirine with modified R-ICE
    Patients will receive loncastuximab tesirine given as a 30-minute intravenous infusion with each cycle of modified R-ICE (maximum three cycles)
  • Experimental: Treatment Arm III - CAR T-cells - TBC
    Patients will receive CAR-T cell therapy - agent TBC

Primary Outcome Measure

Treatment Arm I: BsAb: Occurrence of an objective response (OR) [ Time Frame: At the end of week 12 of treatment ]

Central Contacts

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