While there is currently no cure available for follicular lymphoma, there are many treatment options that may help to slow down or reduce the cancer and improve symptoms (remission). In some cases, follicular lymphoma does not respond to treatment (refractory), or it returns or worsens after initially improving (relapse). This study will test a potential new treatment option for people living with relapsed or refractory follicular lymphoma.
The SYMPHONY-1 study is evaluating if a drug called tazemetostat is safe and effective for the treatment of relapsed or refractory follicular lymphoma when taken in combination with immunotherapy drugs lenalidomide and rituximab. The combination of tazemetostat with lenalidomide and rituximab is investigational, meaning it has not been approved by the FDA to treat relapsed or refractory follicular lymphoma.
Tazemetostat as a monotherapy, meaning when taken alone, is approved by the FDA as a prescription oral medicine to treat:
The approval of tazemetostat in those patients is based on a study that measured the percentage of patients whose tumor shrank or disappeared after treatment and how long that response lasted. Tazemetostat is still being studied to confirm these benefits.
In the SYMPHONY-1 study, tazemetostat will be combined with lenalidomide and rituximab. Lenalidomide is approved by the FDA to treat previously treated follicular lymphoma (FL) in combination with a rituximab product.
It is unknown how tazemetostat in combination with lenalidomide and rituximab will affect your follicular lymphoma and overall health. Your cancer may improve, worsen, or stay the same. There may be risks associated with the study treatment that are unknown at this time. The study doctor will discuss potential risks and benefits with you before you make a decision regarding study participation.
The SYMPHONY-1 study is made up of four parts:
Screening: The study team will complete various assessments to determine if you are eligible for the study. These assessments will include a physical examination, review of your medical history, electrocardiogram (ECG), blood tests, urine tests, imaging (CT, MRI, and PET scans), and biopsies (if not done recently).
Study Treatment: If you qualify for the study and choose to participate, you will be randomly assigned to one of two study treatment groups:
The placebo looks like tazemetostat but does not contain any active medication. Neither you nor the study team will know what you have been assigned to receive.
The study treatments are taken in 12 treatment cycles over the course of one year. You will need to attend four study visits during your first treatment cycle, and then one to two visits for the following cycles.
Maintenance: After one year, you will take tazemetostat or placebo only for up to two years, or until your cancer gets worse.
Follow-up: After completing the study treatment, the study site will check in on your health and well-being. During the follow-up period, you will be contacted by the study site by telephone every 90 days and then asked to return to the study center for scans and blood tests every six months for the first two years, and then once a year thereafter or until your cancer gets worse.
Without clinical trials, we would not have most of the medical treatments we use today. Clinical trials depend on the participation of volunteers like you. By choosing to take part in this study, you will be making a valuable contribution to medical research and helping us learn more about possible treatment options for others with relapsed or refractory follicular lymphoma. Thank you for considering this study.
