What is the OLYMPIA-5 clinical research study?

If you were diagnosed with marginal zone lymphoma (MZL), please know that you are not alone in your medical journey. Follicular lymphoma (FL) is the most common indolent (slow-growing) non-Hodgkin lymphoma (NHL) in Western countries. MZL is an indolent type of NHL.

Currently, we are working on developing potential treatments for FL and MZL. OLYMPIA-5 is a phase 3 clinical research study that aims to evaluate the efficacy, safety, and tolerability of an investigational study drug in combination with a standard immunomodulatory agent compared to standard of care (SOC): a comparator treatment in combination with immunomodulatory agent. This study is specifically for people whose cancer has stopped responding to treatment (also known as “refractory”) or has returned (also known as “relapsed”).

Enrollment for the FL cohort is now complete. This study cohort is no longer accepting new participants. The MZL cohort remains open for enrollment.

Please note that this clinical trial will use an investigational drug product, the safety and efficacy of which has not been fully evaluated by Regulatory Authorities, and which has not received marketing authorization in any country. 

What are the study drugs?

    • Investigational treatment: The investigational treatment will be administered through an intravenous (IV) infusion (a needle in your arm). 
    • Comparator treatment: The comparator treatment will be administered by IV infusion or subcutaneous injection (a needle just under your skin). The comparator treatment is part of the SOC for B-cell non-Hodgkin lymphoma along with chemotherapy.
    • Immunomodulatory agent: The immunomodulatory agent is a capsule which you will take orally (i.e., by mouth). You will have to complete a diary at home to confirm you have taken the pill every day.
This study is made up of two parts. Because Part 1 of this study is complete, you will be placed in Part 2 of the study. For Part 2, you will be randomly chosen to receive either the combination of the investigational treatment and immunomodulatory agent (Arm 1) or the comparator treatment and immunomodulatory agent (Arm 2). You will have an equal chance (50%) of receiving either one of these, similar to flipping a coin. No matter which treatment you participate in, you will receive treatment for your lymphoma.

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 roles and responsibilities if you join the OLYMPIA-5 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, as well as undergoing certain assessments and procedures, such as imaging scans, biopsies, and blood draws.

Participation in the study will include the screening period, treatment phase, and the follow-up phase. During the screening period, several tests will be performed in order to ensure that you are eligible for OLYMPIA-5. Screening may last up to 28 days before the first day of the treatment period.

The treatment phase will last about 1 year with the duration and number of visits depending on which treatment group you participate in and your response to the treatment. The follow-up period will consist of 3 visits occurring every 30 days for up to about 90 days after the end of treatment. Then you will continue to have follow-up visits about every 12 weeks and this will continue until your condition worsens or reoccurs, you withdraw your consent, you start a new therapy for your lymphoma, you can no longer be contacted, or the study is over, whichever is earliest. Disease response assessment will continue after you start a new therapy for your lymphoma until the disease has worsened.

There will be no cost to you for the study drug, 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 drugs 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.

Please note that this clinical trial will use an investigational drug product, the safety and efficacy of which has not been fully evaluated by Regulatory Authorities, and which has not received marketing authorization in any country. 

Find a study site near you

To find out more about OLYMPIA-5, 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)
  • • Have refractory or relapsed MZL
  • • Are willing and able to attend study visits and undergo study-related procedures

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 OLYMPIA-5, please contact the site closest to you by using our site finder tool.
Site Finder