What side effects are associated with this type of intervention?

Common treatments for Follicular Lymphoma, such as rituximab combined with chemotherapy, can cause a range of side effects. Rituximab is associated with infusion reactions, which can be severe, especially during the first cycle. These reactions may include fever, chills, and respiratory symptoms. Chemotherapy can lead to side effects like alopecia (hair loss), neutropenia (low white blood cell count), anemia, and thrombocytopenia (low platelet count). Bispecific antibodies like Odronextamab may also cause similar infusion-related reactions and immune-related side effects, although specific data on Odronextamab's side effects are still being studied.

What prior FDA approvals exist?

The FDA has approved several treatments for Follicular Lymphoma, particularly those targeting the CD20 antigen on B-cells. Rituximab, a monoclonal antibody targeting CD20, has been a cornerstone in the treatment of Follicular Lymphoma, often used in combination with chemotherapy. Other CD20-targeting monoclonal antibodies include obinutuzumab and ofatumumab. Additionally, bispecific antibodies like mosunetuzumab, which targets both CD20 and CD3, have shown promise in clinical trials, similar to the investigational drug Odronextamab.

What other types of research exist?

Promising, novel alternatives to Odronextamab for Follicular Lymphoma patients include: 1) Bispecific fusion proteins targeting 4-1BB and PD-L1, which aim to enhance the immune response against cancer cells while minimizing dose-limiting toxicities. 2) Ibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, which has shown superior progression-free survival (PFS) and overall survival (OS) in various subgroups of chronic lymphocytic leukemia (CLL) and may be applicable to follicular lymphoma. 3) Venetoclax, a BCL-2 inhibitor, which has demonstrated efficacy in combination with other agents in hematologic malignancies. These alternatives represent innovative approaches that could be considered in consultation with a healthcare provider.

← Back to Search

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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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 more

Secondary study objectives

BOR as assessed by ICR

BOR as assessed by local investigator

Best overall response (BOR) as assessed by the investigator

+27 more

Awards & 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

0 / 8Eligibility criteria met

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.