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), Lenalidomide (drug), Rituximab (drug)
- How long the study runs
- Study runs about 88 months (dates as stated)
- About the drug or intervention
- Odronextamab — drug: Administered per the protocol · Lenalidomide — drug: Administered per the protocol · Rituximab — drug: Administered per the protocol
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 580
- Started
- 2023-12-28
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for relapsed/refractory follicular lymphoma
- • Phase3 - 580 participants
- • This study is researching an experimental drug called odronextamab (referred to as study drug), in combination with lenalidomide
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with relapsed/refractory follicular lymphoma
Where?
- • Truro - Royal Cornwall Hospitals NHS Trust, Royal Cornwall Hospital
- • Plymouth - Derriford Hospital and the Royal Eye Infirmary
- • Bournemouth - University Hospitals Dorset
- • Salisbury - Salisbury Foundation Trust
- • +5 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), in combination with lenalidomide. The study is focused on participants who have one of two types of cancer: Follicular Lymphoma (FL) or Marginal Zone Lymphoma (MZL) that has come back after treatment (called "relapsed") or did not respond to treatment (called "refractory"). FL and MZL are subtypes of Non-Hodgkin 's Lymphoma (NHL). This study will be made up of two parts (Part 1 not randomized, Part 2 randomized - controlled). The aim of Part 1 of the study is to see how safe and tolerable the study drug is when used in combination with lenalidomide, in participants with FL or MZL, and to determine the dose of the study drug to be used in Part 2 of this study. This combination is considered "first-in-human" as it has not been tested as a combination treatment in humans before. The aim of Part 2, of the study is to assess how well the combination of the study drug and lenalidomide works compared to the combination of rituximab (called "the comparator drug") and lenalidomide. The combination of comparator drug and lenalidomide is the current standard-of-care treatment for relapsed/refractory FL and/or MZL. 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 in combination with lenalidomide * 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) * The impact from the study drug on 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
Treatment history
Treatments you must have had:
- ✓ (with a duration of at least 2 cycles) of systemic chemo-immunotherapy
What the study is looking for
- ✓Local histologic confirmation of FL grade 1-3a or MZL (nodal, splenic, or extra nodal MZL) as assessed by the...
- ✓Have cancer that can be measured on scans on cross sectional imaging documented by diagnostic Computed Tomography \[CT\], or Magnetic...
- ✓activity scale (ECOG) performance status of 0 to 2.
- ✓Adequate blood and organ health, as described in the protocol.
- ✓All study participants must:
Who cannot take part
- ✗Primary Central Nervous System (CNS) lymphoma or known involvement (either current or prior history of CNS...
- ✗Participants with current or past histological evidence of high-grade or diffuse large B-cell lymphoma, or any...
- ✗History of or current relevant CNS pathology, as described in the protocol.
- ✗Any other significant active disease or medical condition that could interfere with the conduct of the study or put...
- ✗Allergy/hypersensitivity to study drugs or excipients. as described in the protocol.
See the full criteria
Where Is This Study? (9 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 BH7 7DW, United Kingdom
Salisbury Foundation Trust
Salisbury SP6 2ND, United Kingdom
The Hillingdon Hospital
Uxbridge UB8 3NN, United Kingdom
Geraldine Landers
thh.research.hillingdon@nhs.net01895 279021/ Ext 3021The Royal Marsden NHS Foundation Trust
Sutton SM2 5PT, United Kingdom
James Paget University Hospitals NHS Foundation Trust
Great Yarmouth NR31 6LA, United Kingdom
Barking, Havering and Redbridge University Hospitals NHS Trust
Romford RM7 0AG, United Kingdom
South Warwickshire NHS Foundation Trust
Warwick CV34 5BW, United Kingdom
How to Get in Touch
Clinical Trials Administrator
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