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Taking people in IsraelPhase 3

Odronextamab Compared With Standard Treatment for Untreated Follicular Lymphoma

Tests odronextamab against standard treatment in adults with untreated follicular lymphoma.

Key facts

Who runs it
Regeneron Pharmaceuticals
Where
Ashdod, Haifa, Jerusalem, Nahariya, Petah Tikva, Ramat Gan, and Tel Aviv, IsraelSee the 7 sitesAlso in 18 other countries, 182 sites
Registry title
A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Adult Participants With Previously Untreated Follicular Lymphoma
Status
Recruiting
Phase
Phase 3
People taking part
822 people, planned
Started
12 Dec 2023
Expected to end
30 Nov 2029
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Odronextamab
  • Rituximab
  • Cyclophosphamide
  • Doxorubicin
  • Vincristine
  • Prednisone/prednisolone
  • Bendamustine
Record updated
12 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 follicular lymphoma who have not been treated before and who need treatment now.

Age
18 years or older
Sex
All sexes can join
Disease stage
CD20-positive follicular lymphoma, grade 1-3a, stage II bulky or stage III / IV, with disease that can be measured on CT or MRI scans
Earlier treatment
No earlier treatment of the lymphoma with any systemic anti-lymphoma therapy
Biomarker or test result
CD20-positive lymphoma cells

Main reasons for not taking part

  • Lymphoma in the brain or spinal fluid area (CNS or leptomeningeal lymphoma)
  • Lymphoma that has changed into high-grade or diffuse large B-cell lymphoma
  • Waldenström macroglobulinemia, grade 3b follicular lymphoma, chronic lymphocytic leukemia, or small lymphocytic lymphoma
  • Earlier treatment with any systemic anti-lymphoma therapy
  • Infections or allergy to the study drug or its ingredients

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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 measurable disease on cross-sectional imaging documented by diagnostic imaging Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Adequate bone marrow function and hepatic function, as described in the protocol

Who cannot take part

  • Treatment with any systemic anti-lymphoma therapy
  • Infections and allergy/hypersensitivity to study drug or excipient, as described in the protocol; NOTE: Other protocol defined inclusion/exclusion criteria apply
  • 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 leukemia, or small lymphocytic lymphoma

Where in Israel

Also in 18 other countries, 182 sites

  • Samson Assuta Ashdod University HospitalAshdod, IsraelContact: Clinical Trials AdministratorTaking people
  • Bnai Zion Medical CenterHaifa, IsraelContact: Clinical Trials AdministratorTaking people
  • Hadassah medical CenterJerusalem, IsraelContact: Clinical Trials AdministratorTaking people
  • Galilee Medical CenterNahariya, IsraelContact: Clinical Trials AdministratorTaking people
  • Rabin Medical CenterPetah Tikva, IsraelContact: Clinical Trials AdministratorTaking people
  • Chaim Sheba Medical CenterRamat Gan, IsraelContact: Clinical Trials AdministratorTaking people
  • Tel-Aviv Sourasky Medical CenterTel Aviv, IsraelContact: 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. The study is focused on participants with previously untreated follicular lymphoma (a type of non-Hodgkin lymphoma or NHL).

Read full original descriptionShow less

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.

The 2 groups in the trial

  • OdronextamabTreatment being tested

    Part 1 is a safety run-in. All participants will receive odronextamab. In part 2 participants will be randomly assigned in a 1:1 ratio to receive odronextamab followed by odronextamab maintenance.

  • Rituximab + Investigator's Choice ChemotherapyExisting treatment, for comparison

    Part 2 only, participants will be randomized 1:1 to receive rituximab in combination with chemotherapy followed by rituximab maintenance.

    Treatment: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone/prednisolone, and Bendamustine

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

Print a page for my doctor

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 to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 X Anti-CD3 Bispecific Antibody Versus Investigator's Choice in Previously Untreated Participants With Follicular Lymphoma (OLYMPIA-1)
Plain-language title
Odronextamab Compared With Standard Treatment for Untreated Follicular 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
12 November 2026