At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Odronextamab (drug), Rituximab (drug), Cyclophosphamide (drug), Doxorubicin (drug)
- How long the study runs
- Study runs about 71 months (dates as stated)
- About the drug or intervention
- Odronextamab — drug: Administered per the protocol · Rituximab — drug: Administered per the protocol · Cyclophosphamide — drug: Administered per the protocol as part of Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) chemotherapy, or Cyclophosphamide, Vincristine, Prednisone (CVP) chemotherapy · Doxorubicin — drug: Administered per the protocol as part of CHOP chemotherapy · Vincristine — drug: Administered per the protocol as part of CHOP, and CVP chemotherapy · Prednisone/prednisolone — drug: Administered per the protocol as part of CVP chemotherapy · Bendamustine — drug: Administered per the protocol as part of chemotherapy (Rituximab-Bendamustine)
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 822
- Started
- 2023-12-12
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for follicular lymphoma (fl)
- • Phase3 - 822 participants
- • This study is researching an experimental drug called odronextamab, referred to as study drug
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with follicular lymphoma (fl)
Where?
- • Truro - Royal Cornwall Hospitals NHS Trust, Royal Cornwall Hospital
- • Plymouth - Derriford Hospital and the Royal Eye Infirmary
- • Bournemouth - University Hospitals Dorset
- • Glasgow - Beatson West of Scotland Cancer Centre
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on participants with previously untreated follicular lymphoma (a type of non-Hodgkin lymphoma or NHL). This study will be made up of two parts: Part 1 (non-randomized) and Part 2 (randomized - controlled). The aim of Part 1 of the study is to see how safe and tolerable the study drug is when given alone. The aim of Part 2 of the study is to see how the study drug works compared to rituximab (called the "comparator drug") and chemotherapy (the current standard of care for NHL). Standard of care means the usual medication expected and used when receiving treatment for a condition. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects) * How the study drug affects quality of life and ability to complete routine daily activities.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Diagnosis of Cluster of Differentiation 20\^+ (CD20\^+) FL Grade 1-3a, stage II bulky or stage III / IV
- ✓Need for treatment as described in the protocol
- ✓Have cancer that can be measured on scans on cross-sectional imaging documented by diagnostic imaging Computed Tomography (CT) or...
- ✓activity scale (ECOG) performance status of 0-2
- ✓Adequate bone marrow function and liver function, as described in the protocol
Who cannot take part
- ✗Central Nervous System (CNS) lymphoma or leptomeningeal lymphoma
- ✗Histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
- ✗Waldenström Macroglobulinemia (WM, lymphoplasmacytic lymphoma), Grade 3b follicular lymphoma, chronic lymphocytic...
- ✗Treatment with any systemic anti-lymphoma therapy
- ✗Infections and allergy/hypersensitivity to the study treatment or excipient, as described in the protocol
See the full criteria
Where Is This Study? (6 UK sites)
Royal Cornwall Hospitals NHS Trust, Royal Cornwall Hospital
Truro TR1 3LJ, United Kingdom
Derriford Hospital and the Royal Eye Infirmary
Plymouth PL6 8DH, United Kingdom
University Hospitals Dorset
Bournemouth BH77DW, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow G12 0YN, United Kingdom
Norfolk and Norwich University Hospital
Norwich NR4 7UY, United Kingdom
Barking, Havering and Redbridge University Hospitals NHS Trust
Romford RM7 0AG, United Kingdom
How to Get in Touch
Clinical Trials Administrator
Sponsor contactCONTACT