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Looking for participantsPhase3

A Trial to Find Out if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Adult Participants With Follicular Lymphoma and Marginal Zone Lymphoma

Sponsor: Regeneron Pharmaceuticals

NCT ID: NCT06149286

View on ClinicalTrials.gov ↗

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

Relapsed/Refractory Follicular LymphomaRelapsed/Refractory Marginal Zone Lymphoma (R/R MZL)

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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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

CD20

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
Key Inclusion Criteria: 1. Local histologic confirmation of FL grade 1-3a or MZL (nodal, splenic, or extra nodal MZL) as assessed by the investigator, as described in the protocol. 2. Must have refractory disease or relapsed after at least 1 prior line (with a duration of at least 2 cycles) of systemic chemo-immunotherapy or immunotherapy. Prior systemic therapy should have included at least one anti-Cluster of Differentiation 20 (CD20) monoclonal antibody, and participant should meet indication for treatment, as described in the protocol. 3. Have measurable disease on cross sectional imaging documented by diagnostic Computed Tomography \[CT\], or Magnetic Resonance Imaging \[MRI\] imaging, as described in the protocol. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 5. Adequate hematologic and organ function, as described in the protocol. 6. All study participants must: 1. Have an understanding that lenalidomide could have a potential teratogenic risk. 2. Agree to abstain from donating blood while taking study drug therapy and for 28 days after discontinuation of lenalidomide. 3. Agree not to share study medication with another person. 4. Agree to be counseled about pregnancy precautions and risk of fetal exposure associated with lenalidomide. Key Exclusion Criteria: 1. Primary Central Nervous System (CNS) lymphoma or known involvement (either current or prior history of CNS involvement) by non-primary CNS NHL, as described in the protocol. 2. Participants with current or past histological evidence of high-grade or diffuse large B-cell lymphoma, or any histology other than FL grade 1-3a or MZL. 3. History of or current relevant CNS pathology, as described in the protocol. 4. A malignancy other than NHL (inclusion diagnosis) unless the participant is adequately and definitively treated and is cancer free for at least 3 years, with the exception of localized prostate cancer treated with hormone therapy or local radiotherapy (ie, pellets), cervical carcinoma in situ, breast cancer in situ, or nonmelanoma skin cancer that was definitively treated. 5. Any other significant active disease or medical condition that could interfere with the conduct of the study or put the participant at significant risk, as described in the protocol. 6. Allergy/hypersensitivity to study drugs or excipients. as described in the protocol. 7. Active infection as defined in the protocol. Note: Other protocol-defined Inclusion/Exclusion criteria apply

Where Is This Study? (9 UK sites)

Royal Cornwall Hospitals NHS Trust, Royal Cornwall Hospital

Truro TR1 3LJ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Abi Weeks

rch-tr.CornwallResearch@nhs.net01872 25 6424

Derriford Hospital and the Royal Eye Infirmary

Plymouth PL6 8DH, United Kingdom

Recruiting

University Hospitals Dorset

Bournemouth BH7 7DW, United Kingdom

Recruiting
Hospital R&D contact (matched)

Louise Bell

uhd.researchoffice@nhs.net0300 019 8500

Salisbury Foundation Trust

Salisbury SP6 2ND, United Kingdom

Recruiting
Hospital R&D contact (matched)

Kate Ames

sft.sftresearch@nhs.net01722 336262

The Hillingdon Hospital

Uxbridge UB8 3NN, United Kingdom

Recruiting
Hospital R&D contact (matched)

Geraldine Landers

thh.research.hillingdon@nhs.net01895 279021/ Ext 3021

The Royal Marsden NHS Foundation Trust

Sutton SM2 5PT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

James Paget University Hospitals NHS Foundation Trust

Great Yarmouth NR31 6LA, United Kingdom

Recruiting
Hospital R&D contact (matched)

rd.office@jpaget.nhs.uk

rd.office@jpaget.nhs.uk01493 453478

Barking, Havering and Redbridge University Hospitals NHS Trust

Romford RM7 0AG, United Kingdom

Recruiting
Hospital R&D contact (matched)

Heidi Chandler

bhrut.development.research@nhs.net01708 435000 ex 2923

South Warwickshire NHS Foundation Trust

Warwick CV34 5BW, United Kingdom

Recruiting
Hospital R&D contact (matched)

Jo Williams

jo.williams@swft.nhs.uk01926 495321 extn. 8107

How to Get in Touch

Clinical Trials Administrator

Sponsor contact

CONTACT

844-734-6643 clinicaltrials@regeneron.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10