What is the OLYMPIA-1 clinical research study?

If you were diagnosed with follicular lymphoma (FL), please know that you are not alone in your medical journey. FL is one of the most common subtypes of non-Hodgkin lymphoma and affects up to 5 people in every 100,000 in Europe and the U.S.

Currently, we are working on developing potential treatments for FL. OLYMPIA-1 is a phase 3 clinical research study that aims to evaluate the efficacy and safety of an investigational study treatment compared to standard of care (comparator treatment in combination with chemotherapy). This study is specifically for people who have not yet been treated for their FL.

The study treatment is called “investigational” as it has not yet been approved to treat FL.

What are the study treatments?

  • Investigational treatment:
  • The investigational treatment will be administered through an intravenous (IV) infusion (a needle in your arm). The investigational treatment is a bispecific antibody that works by activating your immune system’s T-cells and helping them target and kill cancerous cells.
  • Comparator treatment:
  • The comparator treatment will be administered by IV infusion or subcutaneous injection (a needle just under your skin). The comparator treatment in combination with chemotherapy is the standard of care for FL. It is a monoclonal antibody. It sticks to the surface of a type of white blood cell called a “B-lymphocyte.” When this happens, the cell is killed by the immune system.
  • Chemotherapy treatment:
  • Chemotherapy is administered by IV infusion along with an oral medication (only prednisone or prednisolone). Chemotherapy (chosen by your doctor) will consist of either:
    • cyclophosphamide, doxorubicin, vincristine, and prednisone or prednisolone, known collectively as “CHOP”
    • cyclophosphamide, vincristine, and prednisone or prednisolone, known collectively as “CVP” 

      or
    • bendamustine
This study is divided into 2 parts. In the first part, a small number of participants will receive the investigational study treatment.
In the second part of the study, participants will be randomly assigned to 1 of 2 treatment groups. If you qualify and choose to participate in OLYMPIA-1, you will have an equal (50%) chance of being assigned to either group. One group will receive the investigational treatment, and the other will receive the comparator treatment in combination with chemotherapy. This study is “open label,” which means you will be told which treatment you are receiving.

What can I expect if I participate?

Study participation is 100% voluntary (your choice). You will receive information on what to expect, as well as your role and responsibilities if you join the OLYMPIA-1 study. You may leave the study at any time without it affecting your regular health care.
If you join the study, there are certain things you will be expected to do. This includes attending study visits and undergoing certain assessments and procedures, such as imaging scans, biopsies, blood draws, and quality of life questionnaires.
Participation in the study will include the screening period, treatment phase, maintenance treatment period, and the follow-up phase. During the screening period, several tests will be performed in order to ensure that you are eligible for OLYMPIA-1. Screening may last up to 28 days before the first day of the treatment period. The treatment phase may last up to 2.5 years depending on which treatment group you are assigned to and your response to the study treatment. You will then have follow-up visits every 30 days for up to 90 days, then every 12 weeks for the first 3 years, then every 24 weeks for the next 2 years, and then 1 time a year after that until your disease gets worse, or you withdraw consent from the study, whichever is earliest. You may have the chance to have some of these visits remotely. Please ask your study doctor for more information.

There will be no cost to you for the study treatment, study doctor’s time, or procedures and supplies related to the study. The study sponsor will cover these costs. You or your health insurance will have to pay for medical care that would be recommended for your treatment even if you were not in the study. You will also have to pay for medications, tests, and supplies that are not required as part of the study. Your study doctor and study team are available to discuss this with you.

What else should I know?

As with all treatments, there are possible risks when taking the investigational treatment. If you qualify and choose to participate, you will be provided with an Informed Consent Form that explains any possible risks and side effects. It is also possible that the study treatment may affect you in unknown ways. Your health and safety are our top priorities and will be closely monitored throughout your participation.

There is no guarantee that you will receive a medical benefit from participating in this study. Your condition may get better, stay the same, or may even get worse. You are free to withdraw from the study for any reason and at any time.

Find a study site near you

To find out more about OLYMPIA-1, and whether it may be right for you, please contact your closest study site – they will be more than happy to help. Find your nearest study site. 

Site Finder

Am I Eligible?

You may be eligible if you:

  • Are ≥18 years of age (or the legal age of consent in your country)
  • Were diagnosed with, but not yet treated for FL (that has not spread to the brain)
  • Are willing and able to comply with clinic visits and study-related procedures, and to understand and complete questionnaires with physical assistance if necessary

There are other requirements to participate. A full medical check-up will be done to see if you can join this study. If you have other questions, share this website with your doctor to discuss this study.

Find a study site near you

If you have more questions about OLMYPIA-1, please contact the site closest to you by using our site finder tool.
Site Finder