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Looking for participantsPhase3

A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Adult Patients With Previously Untreated Diffuse Large B-cell Lymphoma

Sponsor: Regeneron Pharmaceuticals

NCT ID: NCT06091865

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), Rituximab (drug), Cyclophosphamide (drug), Doxorubicin (drug)
How long the study runs
Study runs about 69 months (dates as stated)
About the drug or intervention
Odronextamab — drug: Odronextamab will be administered by intravenous (IV) infusion · Rituximab — drug: Rituximab will be administered IV, or subcutaneously (SC) · Cyclophosphamide — drug: Cyclophosphamide will be administered IV as part of chemotherapy · Doxorubicin — drug: Doxorubicin will be administered IV as part of chemotherapy · Vincristine — drug: Vincristine will be administered IV as part of chemotherapy · Prednisone/Prednisolone — drug: Prednisone or prednisolone will be administered orally (PO) as part of chemotherapy
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
904
Started
2023-12-13
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for diffuse large b-cell lymphoma (dlbcl)
  • • Phase3 - 904 participants
  • • This study is researching an experimental drug called odronextamab, referred to as study drug, when used in combination with chemotherapy

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with diffuse large b-cell lymphoma (dlbcl)

Where?

  • • Aberdeen - NHS Grampian: Aberdeen Royal Infirmary
  • • Uxbridge - The Hillingdon Hospitals NHS Foundation Trust

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, when used in combination with chemotherapy. The study is focused on patients with Diffuse Large B-cell Lymphoma (DLBCL) that have not been treated before (called "previously untreated"). Patients with DLBCL that have come back after treatment (called "relapsed"), or have not responded to treatment (called "refractory"), can also participate in this study. This study will be made up of Part 1A, Part 1B, and Part 2.The aim of Part 1A and Part 1B of the study is to see how safe and tolerable the study drug in combination with chemotherapy is and to determine the dose and schedule of the study drug to be combined with chemotherapy in Part 2 of the study. The aim of Part 2 of the study is to see how effective the combination of the study drug with chemotherapy is in comparison with the combination of rituximab (the comparator drug), and chemotherapy, the current standard of care treatment approved for DLBCL. 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 when combined with chemotherapy * 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

Diffuse Large B-cell Lymphoma (DLBCL)

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

What the study is looking for

  • ✓cancer that can be measured on scans with at least one nodal lesion or at least one extranodal lesion, as described in the protocol
  • ✓activity scale (ECOG) performance status ≤2
  • ✓Life expectancy ≥ 12 months
  • ✓International Prognostic Index (IPI) of 3 to 5 (part 1 only) and ≥2 (part 2) for untreated DLBCL only
  • ✓Adequate blood and organ health, as defined in the protocol.

Who cannot take part

  • ✗Primary Central Nervous System (CNS) lymphoma or known involvement by non-primary CNS NHL and history or current...
  • ✗Another active cancer, significant active disease or medical condition, as described in the protocol
  • ✗Peripheral neuropathy Grade ≥3
  • ✗Any other therapy or investigational treatment within 28 days or 5 half-lives of the drug, whichever is shorter,...
  • ✗Recent major surgery, prior organ transplantation, or standard radiotherapy, as described in the protocol
See the full criteria
Key Inclusion Criteria: 1. Previously untreated participants for lymphoma with documented Cluster of Differentiation 20+ (CD20+) DLBCL, as described in the protocol OR relapsed or refractory DLBCL, for whom next available standard of care therapy is not available or deemed ineligible according to the investigator (Part 1A only) 2. Measurable disease with at least one nodal lesion or at least one extranodal lesion, as described in the protocol 3. Eastern Cooperative Oncology Group (ECOG) performance status ≤2 4. Life expectancy ≥ 12 months 5. International Prognostic Index (IPI) of 3 to 5 (part 1 only) and ≥2 (part 2) for untreated DLBCL only 6. Adequate hematologic and organ function, as defined in the protocol. Key Exclusion Criteria: 1. Primary Central Nervous System (CNS) lymphoma or known involvement by non-primary CNS NHL and history or current relevant CNS pathology 2. Another active malignancy, significant active disease or medical condition, as described in the protocol 3. Peripheral neuropathy Grade ≥3 4. Treatment with any systemic anti-lymphoma therapy, except for participants with Relapsed/Refractory (R/R) DLBCL and participants with DLBCL transformed from an indolent lymphoma after treatment with systemic anti-lymphoma therapy. 5. Any other therapy or investigational treatment within 28 days or 5 half-lives of the drug, whichever is shorter, prior to the start of study treatment 6. Recent major surgery, prior organ transplantation, or standard radiotherapy, as described in the protocol 7. Allergy/hypersensitivity to study drugs, as described in the protocol 8. Infections such as any active infection (bacterial, viral, fungal, mycobacterial, parasitic or other), active Coronavirus Disease (COVID-19) infection, uncontrolled infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV), Cytomegalovirus (CMV) infection, as described in the protocol. Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Where Is This Study? (2 UK sites)

NHS Grampian: Aberdeen Royal Infirmary

Aberdeen AB25 2ZN, United Kingdom

Recruiting
Hospital R&D contact (matched)

Fiona Brebner

gram.randd@nhs.scot01224 551121

The Hillingdon Hospitals NHS Foundation Trust

Uxbridge UB8 3NN, United Kingdom

Recruiting
Hospital R&D contact (matched)

Geraldine Landers

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

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