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Taking people in United KingdomPhase 3

Compares odronextamab with chemotherapy against rituximab with chemotherapy in lymphoma

Tests odronextamab plus chemotherapy in adults with untreated diffuse large B-cell lymphoma.

Key facts

Who runs it
Regeneron Pharmaceuticals
Where
Aberdeen and Uxbridge, United KingdomSee the 2 sitesAlso in 20 other countries, 193 sites
Registry title
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
Status
Recruiting
Phase
Phase 3
People taking part
904 people, planned
Started
13 Dec 2023
Expected to end
12 Sept 2029
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Odronextamab
  • Rituximab
  • Cyclophosphamide
  • Doxorubicin
  • Vincristine
  • Prednisone/Prednisolone
Record updated
4 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with diffuse large B-cell lymphoma (DLBCL) that has not been treated before. In Part 1A only, people whose DLBCL came back or did not respond can also join.

Age
18 years or older.
Sex
All sexes can join.
Disease stage
CD20-positive DLBCL not yet treated, with measurable disease. International Prognostic Index (IPI) of 3 to 5 in Part 1 and 2 or higher in Part 2. In Part 1A only, relapsed or refractory DLBCL with no standard therapy available.
Earlier treatment
No earlier treatment for lymphoma, except people with relapsed or refractory DLBCL, or DLBCL that changed from a slow-growing lymphoma. No other therapy or trial treatment within 28 days or 5 half-lives of the drug, whichever is shorter, before the start.
Biomarker or test result
The lymphoma must be CD20-positive (CD20+).

Main reasons for not taking part

  • Lymphoma in the central nervous system (CNS), or relevant CNS disease
  • Another active cancer or significant active disease
  • Peripheral neuropathy Grade 3 or higher
  • Active infection, or uncontrolled HIV, hepatitis B or hepatitis C
  • Recent major surgery, earlier organ transplant, or allergy to the study drugs

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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)
  • Measurable disease with at least one nodal lesion or at least one extranodal lesion, as described in the protocol
  • Eastern Cooperative Oncology Group (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 hematologic and organ function, as defined in the protocol

Who cannot take part

  • 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
  • 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
  • Recent major surgery, prior organ transplantation, or standard radiotherapy, as described in the protocol
  • Another active malignancy, significant active disease or medical condition, as described in the protocol
  • Allergy/hypersensitivity to study drugs, as described in the protocol
  • 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
  • Primary Central Nervous System (CNS) lymphoma or known involvement by non-primary CNS NHL and history or current relevant CNS pathology
  • Peripheral neuropathy Grade ≥3

Where in United Kingdom

Also in 20 other countries, 193 sites

  • NHS Grampian - Aberdeen Royal InfirmaryAberdeen, United KingdomContact: Clinical Trials AdministratorTaking people
  • The Hillingdon Hospitals Nhs Foundation TrustUxbridge, United KingdomContact: Clinical Trials AdministratorTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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

The 2 groups in the trial

  • Odronextamab + CHOPTreatment being tested

    Part 1, includes dose escalation (Part 1A), and randomized exploration of 2 regimens of odronextamab -cyclophosphamide, doxorubicin, vincristine, prednisone (Odro-CHOP) dose optimization (Part 1B).

    Treatment: Odronextamab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone/Prednisolone

  • Rituximab + CHOPExisting treatment, for comparison

    Part 2 is the randomized controlled portion, participants will receive either Odro-CHOP or R-CHOP.

    Treatment: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone/Prednisolone

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 3, Open Label, Randomized Study Comparing the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 × Anti-CD3 Bispecific Antibody, in Combination With CHOP (ODRO-CHOP) Versus Rituximab in Combination With CHOP (R-CHOP) in Previously Untreated Participants With Diffuse Large B-cell Lymphoma (DLBCL) (OLYMPIA-3)
Plain-language title
Compares odronextamab with chemotherapy against rituximab with chemotherapy in lymphomaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
4 November 2026