What is this study trying to find out about B-cell Non Hodgkin Lymphoma?

This study is evaluating new medicines for children and young people with relapsed or refractory B-cell Non Hodgkin Lymphoma to see if they are safe and effective. It aims to identify better treatment options for this rare and challenging cancer. The University of Birmingham is leading this international research effort.

Who may be eligible for this B-cell Non Hodgkin Lymphoma clinical trial?

Children and young people up to 25 years old with relapsed or refractory B-cell Non Hodgkin Lymphoma may be eligible. Participants must have a good performance status and adequate organ function. Those pregnant, breastfeeding, or with certain infections are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this B-cell Non Hodgkin Lymphoma clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants can plan accordingly for any additional costs.

Actively Recruiting

Phase 2

Phase 3

Age: 0 - 25Years

All Genders

ID05991388

Global Study Evaluating New Treatments for Children and Young Adults Up to 25 Years with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Led by University of Birmingham · Updated on 2026-02-20

210

Participants Needed

Research Sites

104 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating new medicines for children and young people up to 25 years old with relapsed or refractory B-cell non-Hodgkin Lymphoma B-NHL, a type of cancer affecting lymph nodes and organs like the liver or spleen. This international adaptive trial aims to find safer and more effective treatments, focusing on three groups receiving different novel therapies. The study uses a design that allows adding or removing treatments based on their effectiveness and safety in this rare cancer. Participants will receive one of three treatments odronextamab given by intravenous infusion weekly and then less frequently over up to two years loncastuximab tesirine combined with modified R-ICE chemotherapy for up to three cycles or CAR T-cell therapy with details to be confirmed. These treatments are tested in parallel groups, and if a medicine appears ineffective, it may be stopped and replaced by another. The trial allows children to switch groups if their cancer does not respond. During the study, researchers will monitor participants through regular assessments including imaging and laboratory tests to evaluate cancer response and side effects. They will check treatment responses at specific times during treatment cycles and follow patients for at least two years after treatment to monitor long-term outcomes and safety. This includes tracking survival times, adverse events, and overall treatment effectiveness to provide important information about these new therapies.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 0 - 25Years

All Genders

Eligibility Criteria

You may qualify if you...

Histologically confirmed mature B-cell non-Hodgkin Lymphoma including specific subtypes at initial diagnosis
Radiological or histological proof of relapsed or refractory B-NHL
Biopsy required if relapse occurs more than two years after previous therapy
Measurable disease by defined nodal, extra-nodal, bone marrow, or CNS criteria
Age from birth to 25 years at trial entry
Performance status score of 50 or higher
Life expectancy of at least 8 weeks
Adequate bone marrow function with specified platelet and neutrophil counts unless bone marrow involvement
Adequate liver function with AST/ALT and bilirubin within defined limits
Negative pregnancy test for females of childbearing potential
Agreement to use effective contraception during and for 12 months after treatment
Written informed consent provided
Additional criteria apply for specific treatment arms including renal function and prior therapies

You will not qualify if you...

Diagnosis of B-cell Acute Lymphoblastic Leukaemia or B-cell Lymphoblastic Lymphoma
Recent stem cell transplant within specified timeframes
Recent graft versus host disease requiring therapy
Recent investigational treatment or radiation therapy
Ongoing acute toxicities from prior lymphoma treatment
Known DNA repair disorders or primary immunodeficiency
Pregnancy or breastfeeding
Inability to adhere to follow-up schedule
Expected non-compliance with treatment or trial procedures
Uncontrolled severe infections
Known HIV infection
Hepatitis B carrier or history with positive serology
Live vaccine within 28 days before trial entry
Known hypersensitivity to study treatments or excipients
Additional restrictions for specific treatment arms including CNS-only disease, cardiac function, and prior therapies

Research Team

Joseph Rogers

Sarah Johnson

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