OncoMatch/Clinical Trials/NCT05991388
A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-cell Non-Hodgkin Lymphoma
Is NCT05991388 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2/3 trial studies multiple treatments for b-cell non hodgkin lymphoma.
Treatment: Odronextamab · Loncastuximab tesirine · Rituximab · Ifosfamide · Carboplatin · Etoposide · Etoposide Phosphate · Dexamethasone · CAR T-cells (TBC) — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Chemotherapy
Other
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Excluded: CD20 negative disease at initial diagnosis
Known CD20 negative disease at initial diagnosis
Demographics
Prior therapy
Must have received: lymphoma-directed therapy — relapsed or refractory
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
Cannot have received: allogenic HSCT
Exception: within 90 days
Patients within: 90 days after an allogenic HSCT procedure
Cannot have received: autologous HSCT
Exception: within 45 days
Patients within: 45 days after an autologous HSCT procedure
Cannot have received: CAR T-cell therapy or other cellular therapies
Exception: within 28 days (arm I), within 42 days (arm II)
Patients within 28 days of any CAR-T cell therapy or other cellular therapies (arm I); Patients within 42 days of any CAR-T cell therapy or other cellular therapies (arm II)
Cannot have received: investigational treatment
Exception: within 14 days
Patients within: 14 days of previous investigational treatment
Cannot have received: craniospinal radiation
Exception: within 28 days
Patients within: 28 days of receiving craniospinal radiation
Cannot have received: radiation therapy
Exception: within 14 days
Patients within: 14 days of any other radiation
Cannot have received: CD20 x CD3 bispecific therapy
Prior treatment with CD20 x CD3 bispecific therapy
Lab requirements
Blood counts
Platelet count ≥50x10^9/L (no platelet transfusion within 7 days) unless bone marrow involvement; ANC ≥0.75x10^9/L (no G-CSF within 2 days) unless bone marrow involvement; For arm I with bone marrow involvement: Platelet count ≥25x10^9/L (no platelet transfusion within 3 days), Hgb ≥7 g/dL, ANC ≥0.5x10^9/L (no G-CSF within 2 days)
Kidney function
Creatinine clearance >45 ml/min (arm I); measured GFR >60 ml/min/1.73m^2 (arm II)
Liver function
AST and/or ALT ≤5 x ULN; Total bilirubin ≤1.5 x ULN (Gilbert syndrome: excluded if total bilirubin >4 x ULN)
Cardiac function
Left ventricular shortening fraction (LVSF) <27% or LVEF <50% excluded (arm I); any evidence of pericardial effusion (except trace/physiological) or clinically significant arrhythmias excluded (arm I)
Adequate bone marrow function documented by: Platelet count ≥50x10^9/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: AST and/or ALT ≤5 x ULN; Total bilirubin ≤1.5 X ULN; 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) (arm I); measured GFR >60 ml/min/1.73m^2 (arm II); Cardiac: LVSF <27% or LVEF <50% excluded (arm I); any evidence of pericardial effusion (except trace/physiological) or clinically significant arrhythmias excluded (arm I)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05991388 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior allogenic HSCT, autologous HSCT, CAR T-cell therapy or other cellular therapies disqualifies patients from enrollment.
Are patients with CD20 alterations eligible?
No. CD20 negative disease at initial diagnosis is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 25 years or younger and at least 0 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages