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

ConditionB-cell Non Hodgkin Lymphoma
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
AgeUp to 25
SponsorUniversity of Birmingham

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

at least one bi-dimensionally measurable nodal lesion >1.5 cm in its longest dimension;

Disqualifiers

B-cell Acute Lymphoblastic Leukaemia (B-ALL)/B-cell Lymphoblastic Lymphoma (B-LBL)

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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/Vaccine

    Modified R-ICE chemotherapy

Treatment groups

210 Participants
are divided into 3 treatment groups
Group A: Treatment Arm I - BsAb - OdronextamabExperimental treatment 1 intervention
Group B: Treatment Arm II - ADC with Standard Chemotherapy - Loncastuximab tesirine with modified R-ICEExperimental treatment 7 interventions
Group C: Treatment Arm III - CAR T-cells - TBCExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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)

Time frame
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)

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

Secondary outcomes

1

Event-free survival time (EFS)

All treatment arms

Time frame
From start of treatment until last patient has been followed up for 2 years
2

Progression-free survival time (PFS)

All treatment arms

Time frame
From start of treatment until last patient has been followed up for 2 years
3

Overall survival time (OS)

All treatment arms

Time frame
From start of treatment until last patient has been followed up for 2 years
4

Best overall response (BOR) during treatment

All treatment arms

Time frame
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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Birmingham

Lead sponsor

Cancer Research UK

Collaborator

Fight Kids Cancer

Collaborator

Regeneron Pharmaceuticals

Collaborator

ADC Therapeutics S.A.

Collaborator

Source ClinicalTrials.gov
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