What is the
OLYMPIA-3
clinical research study?
If you have been diagnosed with diffuse large B-cell lymphoma (DLBCL), please know that you are not alone in your medical journey. DLBCL is the most common subtype of non-Hodgkin lymphoma, and accounts for about 1/3 of all newly diagnosed cases.
We are developing potential treatments for DLBCL. OLYMPIA-3 is a phase 3 clinical research study that aims to evaluate the efficacy, safety, and tolerability of an investigational treatment in combination with chemotherapy compared to a standard of care (SOC) treatment in combination with chemotherapy.
The study treatment is called “investigational” as it has not yet been approved to treat DLBCL.
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 – a type of protein that works with white blood cells from your immune system called T-cells to help those T-cells 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 is part of standard of care for untreated DLBCL. It is a monoclonal antibody that targets proteins on the surface of cancer cells (called CD20) found in white blood cells called B-cells. When this happens, the B-cell is killed by the immune system.
- Chemotherapy treatment:
- Both groups (investigational and comparator) will receive the same chemotherapy in combination with their treatment. Chemotherapy is administered by IV infusion along with an oral medication. Chemotherapy will consist of cyclophosphamide, doxorubicin, vincristine, and prednisone or prednisolone, known collectively as “CHOP.”
This study is divided into two parts. In the first part, a small number of participants will receive the investigational study treatment in combination with CHOP. Once that is complete, the second part begins.
In the second part of the study, patients are randomly assigned to 1 of 2 treatment groups in Part 2 of the study. Participants will have an equal chance of receiving either one of these treatments, similar to flipping a coin. No matter which treatment group you participate in, you will receive treatment for your lymphoma. You and your doctor will know 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 roles and responsibilities if you join the OLYMPIA-3 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 to ensure that you are eligible for OLYMPIA-3. Screening may last up to 28 days before the first day of the treatment period. The treatment phase will last about 6 months with approximately 12-20 study visits depending on which treatment group you participate in, and your response to treatment. The follow-up period will consist of visits up to 6 times per year until your condition worsens, you withdraw your consent, or the study is over, whichever is earliest.
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 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.
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-3, 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.
Am I Eligible?
Am I Eligible?
You may be eligible if you:
You may be eligible if you:
- • Are ≥ 18 years of age (or legal age of consent in your country)
- • Were diagnosed with DLBCL
- • Have DLBCL that is measurable
- • Are willing and able to comply with clinic visits and study-related procedures, and understand and complete questionnaires
There are other requirements to participate. A full medical check-up will be done to see if you can participate in this study. If you have other questions, share and discuss this website with your doctor.
Find a study site near you
Find a study site near you
If you have more questions about OLYMPIA-3, please contact the site closest to you by using our site finder tool.