Actively Recruiting
A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-cell Non-Hodgkin Lymphoma
Led by University of Birmingham · Updated on 2026-02-20
210
Participants Needed
11
Research Sites
104 weeks
Total Duration
On this page
Sponsors
U
University of Birmingham
Lead Sponsor
C
Cancer Research UK
Collaborating Sponsor
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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years depending on treatment arm and response
Participants receive one of three treatment options depending on their assigned arm: weekly intravenous infusions of odronextamab for 12 weeks then less frequently up to two years; loncastuximab tesirine given with modified R-ICE chemotherapy for up to 3 cycles; or CAR T-cell therapy.
Weekly visits for 12 weeks, then every two weeks until 9 months, then every four weeks thereafter (Treatment Arm I); Up to 3 cycles of 28 days each with infusions during each cycle (Treatment Arm II); Visit schedule for CAR T-cell therapy to be confirmed (Treatment Arm III)
Duration - Up to 2 years
Participants are monitored for safety and disease progression for up to 2 years after starting treatment, including assessment of survival and adverse events.
Regular follow-up visits scheduled over 2 years
Trial Site Locations
Total: 11 locations
1
The Children's Hospital at Westmead
Sydney, New South Wales, Australia
Not Yet Recruiting
2
Queensland Children's Hospital
Brisbane, Queensland, Australia
Not Yet Recruiting
3
Perth Children's Hospital
Perth, Washington, Australia
Actively Recruiting
4
St. Anna Children's Hospital
Vienna, Austria
Actively Recruiting
5
UZ Leuven
Leuven, Belgium
Not Yet Recruiting
6
Princess Máxima Centre for Pediatric Oncology
Utrecht, Netherlands
Actively Recruiting
7
Starship Children's Hospital
Auckland, New Zealand
Not Yet Recruiting
8
Sahlgrenska University Hospital
Gothenburg, Sweden
Not Yet Recruiting
9
Birmingham Children's Hospital
Birmingham, United Kingdom
Actively Recruiting
10
Bristol Royal Hospital for Children
Bristol, United Kingdom
Actively Recruiting
11
Royal Manchester Children's Hospital
Manchester, United Kingdom
Actively Recruiting
Research Team
J
Joseph Rogers
S
Sarah Johnson
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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