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Anti-tumor antibiotic
Odronextamab + Chemotherapy for Follicular Lymphoma (OLYMPIA-2 Trial)
Phase 3
Recruiting
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have diagnosis of cluster of differentiation 20 positive (CD20+) FL grade 1-3a, stage II bulky or stage III / IV
For Part 2: previously untreated participants who have FLIPI-1 score of 0 to 5
Must not have
Participants with histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
Participants with central nervous system lymphoma or leptomeningeal lymphoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing a new drug called odronextamab combined with chemotherapy for people with a type of blood cancer called follicular lymphoma. It aims to find out how safe and effective this combination is, especially for those who haven't been treated before or whose cancer came back or didn't respond to previous treatments. The study will also compare this new treatment to the current standard treatment and look at side effects and quality of life.
Who is the study for?
Adults with previously untreated follicular lymphoma can join this trial. They should be able to perform daily activities (ECOG 0-2) and have a certain level of disease severity (FLIPI-1 score). Participants must not have other types of lymphomas, recent major surgeries, organ transplants, or any condition that could risk their safety in the study.
What is being tested?
The trial is testing odronextamab combined with chemotherapy against the standard rituximab with chemotherapy. It's divided into three parts: initial non-randomized phases to determine safe dosages and a final phase comparing effectiveness between treatments.
What are the potential side effects?
Potential side effects include reactions to odronextamab such as immune responses against the drug, infusion-related symptoms, impact on blood levels and organ function. The study also monitors quality-of-life changes due to treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lymphoma is CD20 positive and is either stage II bulky or stage III/IV.
Select...
My FLIPI score for lymphoma is between 0 and 5, and I haven't been treated yet.
Select...
I am able to get out of my bed or chair and move around.
Select...
My cancer can be measured on a CT or MRI scan.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My lymphoma has changed into a more aggressive form.
Select...
I have lymphoma in my brain or spinal cord.
Select...
I have been diagnosed with a specific type of blood cancer.
Select...
I have no other major illnesses that could affect my participation in the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Complete Response rate at 30 months (CR30) assessed by independent central review (ICR)
Incidence of dose limiting toxicities (DLTs) for odronextamab in combination with chemotherapy
Incidence of treatment-emergent adverse events (TEAEs) of odronextamab in combination with chemotherapy
+1 moreSecondary study objectives
BOR as assessed by ICR
BOR as assessed by local investigator
Best overall response (BOR) as assessed by the investigator
+27 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Odronextamab + Chemotherapy + No maintenanceExperimental Treatment2 Interventions
In Part 2, participants will be randomized 1:1:1 to receive odronextamab with chemotherapy (CHOP, or CVP) without maintenance.
Group II: Odronextamab + Chemotherapy + MaintenanceExperimental Treatment2 Interventions
In Part 2, participants will be randomized 1:1:1 to receive odronextamab with chemotherapy \[CHOP, or cyclophosphamide, vincristine, and prednisone (CVP)\], followed by odronextamab monotherapy maintenance.
Group III: Odronextamab + ChemotherapyExperimental Treatment4 Interventions
Part 1 of the study includes ordonextamab dose escalation for participants with previously untreated FL and relapsed/refractory FL (Part 1A only) followed by a randomized exploration of 2 regimens of odronextamab (Odro) and cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) with the objective of dose optimization (Part 1B) in previously untreated patients with FL.
Group IV: Rituximab + ChemotherapyActive Control6 Interventions
In Part 2 only, participants will be randomized 1:1:1 to receive rituximab (R) with chemotherapy (CHOP), followed by rituximab monotherapy maintenance.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxorubicin
2012
Completed Phase 3
~8030
Cyclophosphamide
2010
Completed Phase 4
~2310
Vincristine
2003
Completed Phase 4
~2970
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Follicular Lymphoma treatments often target specific proteins on the surface of cancer cells to enhance the immune system's ability to destroy them. Rituximab, a monoclonal antibody, targets the CD20 protein on B-cells, marking them for destruction by the immune system.
Odronextamab, an experimental bispecific antibody, targets both CD20 on B-cells and CD3 on T-cells, bringing these cells together to enhance the immune response against the lymphoma. Chemotherapy works by killing rapidly dividing cells, including cancer cells.
These targeted therapies are crucial for Follicular Lymphoma patients as they offer more precise and potentially more effective treatment options with potentially fewer side effects compared to traditional chemotherapy.
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Who is running the clinical trial?
Regeneron PharmaceuticalsLead Sponsor
664 Previous Clinical Trials
385,208 Total Patients Enrolled
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
283 Previous Clinical Trials
254,349 Total Patients Enrolled
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