NCT06091254 · Regeneron Pharmaceuticals
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 Participants With Follicular Lymphoma
(OLYMPIA-1)
What this study is about
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). This study will be made up of two parts: Part 1 (non-randomly assigned) and Part 2 (randomly assigned - controlled).
View original scientific description
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). 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.
Interventions
DRUG
Odronextamab
Administered per the protocol
DRUG
Rituximab
Administered per the protocol
DRUG
Cyclophosphamide
Administered per the protocol as part of Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) chemotherapy, or Cyclophosphamide, Vincristine, Prednisone (CVP) chemotherapy
DRUG
Doxorubicin
Administered per the protocol as part of CHOP chemotherapy
DRUG
Vincristine
Administered per the protocol as part of CHOP, and CVP chemotherapy
DRUG
Prednisone/prednisolone
Administered per the protocol as part of CVP chemotherapy
DRUG
Bendamustine
Administered per the protocol as part of chemotherapy (Rituximab-Bendamustine)
Primary outcome measures
Incidence of Dose-Limiting Toxicities (DLTs) for odronextamab
Time frame: Up to 35 days
Part 1
Incidence of Treatment-Emergent Adverse Events (TEAEs) of odronextamab
Time frame: Up to 2 years
Part 1
Severity of TEAEs of odronextamab
Time frame: Up to 2 years
Part 1
Complete Response at 30 months (CR30) as assessed by independent central review
Time frame: Up to 30 months
Part 2
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Diagnosis of Cluster of Differentiation 20\^+ (CD20\^+) FL Grade 1-3a, stage II bulky or stage III / IV 2. Need for treatment as described in the protocol 3. Have measurable disease on cross-sectional imaging documented by diagnostic imaging Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 5. Adequate bone marrow function and hepatic function Key
Exclusion criteria
- Central Nervous System (CNS) lymphoma or leptomeningeal lymphoma 2. Histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma 3. Waldenström Macroglobulinemia (WM, lymphoplasmacytic lymphoma), Grade 3b follicular lymphoma, chronic lymphocytic leukemia, or small lymphocytic lymphoma 4. Treatment with any systemic anti-lymphoma therapy 5. Infections and allergy/hypersensitivity to study drug or excipient NOTE: Other protocol defined inclusion/exclusion criteria apply
Where
- Tucson, Arizona
- Los Angeles, California
- Orange, California
- Noblesville, Indiana
- Boston, Massachusetts
- Detroit, Michigan
- Hattiesburg, Mississippi
- New York, New York
- Stony Brook, New York
- Westbury, New York
- Chapel Hill, North Carolina
- Charlotte, North Carolina
And 8 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 24, 2026 · Source of record for eligibility and locations