Active not recruitingPHASE3INTERVENTIONAL

A Study to Assess the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Tazemetostat in Combination With Lenalidomide Plus Rituximab Versus Placebo in Combination With Lenalidomide Plus Rituximab in Adult Patients at Least 18 Years of Age With Relapsed/Refractory Follicular Lymphoma.

This research study is looking at a new drug called Tazemetostat for adults aged 18 and over who have follicular lymphoma. This is a type of blood cancer that has either returned after previous treatment ('relapsed') or isn't responding to current treatments ('refractory'). The study aims to find out if Tazemetostat, when given with other standard medications (Lenalidomide and Rituximab), is safe and effective. It compares this new combination to a combination of dummy medication (placebo) with the standard drugs. The main goal is to see if Tazemetostat can help people live longer without their cancer getting worse. The study has several stages, with the initial stage already completed, focusing on safety and dosage.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Epizyme, Inc.

Enrolment target

599

Start

11 Jun 2020

Estimated completion

01 Mar 2029

Relapsed/Refractory Follicular Lymphoma Follicular Lymphoma Refractory Follicular Lymphoma

What is this study about?

This study is designed for adults with a type of blood cancer called follicular lymphoma. You might hear this described as 'relapsed/refractory', which means the cancer has either returned after getting better with previous treatment, or it's no longer responding to the treatments you've had. The main purpose of this research is to see if adding a new drug, called Tazemetostat, to existing treatments (Lenalidomide and Rituximab) is safe and helps people better control their cancer.

The study compares two groups: one group will receive Tazemetostat alongside Lenalidomide and Rituximab, and the other group will receive a 'dummy' drug (a placebo) with Lenalidomide and Rituximab. This comparison helps researchers understand the benefits and side effects specifically from Tazemetostat. The first phase of the study, which has already finished, focused on finding the safest dose for the new drug combination.

The later stages of the study will focus on how well the treatment works. Researchers will measure how long participants live without their cancer getting worse, and they will also monitor any side effects. This research is important because it could lead to new treatment options for people with follicular lymphoma.

Key takeaways

Study for adults with relapsed or refractory follicular lymphoma.
Compares new drug (Tazemetostat) with existing treatments.
Aims to assess safety and effectiveness in controlling cancer.
Includes a placebo group for comparison.
Involves regular treatment cycles and long-term follow-up.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you must be 18 years or older and have a confirmed diagnosis of follicular lymphoma, specifically grades 1 to 3A.

Your lymphoma must be 'relapsed' (meaning it has returned after getting better with previous treatment) or 'refractory' (meaning it's not responding to current treatments). You must have already received at least one course of treatment for your lymphoma, such as chemotherapy or immunotherapy.

The study also has specific health requirements, such as your general health, expected lifespan, and certain test results for infections like hepatitis B, hepatitis C, and HIV. If you have HIV, it needs to be well-controlled with medication.

Quick self-check

Are you 18 years old or over?
Do you have follicular lymphoma, grades 1 to 3A?
Has your lymphoma come back or not responded to previous treatment?
Have you had at least one prior anti-cancer treatment?
Do you meet certain health criteria (e.g., regarding expected lifespan, hepatitis, or HIV status)?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, the study will involve regular visits to the clinic. Your treatment will be given in 28-day cycles. After 12 cycles, some participants will continue with a long-term 'maintenance' treatment, which could be the study drug or a placebo, depending on which group you were assigned to initially. You might have extra blood tests if you're participating in certain regions like China, to help researchers understand how the medication works in the body. All participants will be carefully monitored for up to 5 years after the last person joins the study to see how the treatment works over time and to check for any long-term effects.

Potential risks and benefits

Participating in research studies like this could offer potential benefits, such as access to a new treatment that isn't widely available yet, and you'll receive close medical monitoring. However, there are also potential risks; the study drug or the combination of drugs might cause side effects, some of which could be serious. All potential side effects would be explained in detail before you decide to take part. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (204)

Southern Cancer Center
Mobile, United States
Arizona Oncology Associates - Tuscon-Rusadill Road
Tucson, United States
TOI - Clinical Research
Cerritos, United States
UCSF Fresno
Clovis, United States
UC San Diego Health Sciences
La Jolla, United States
UCLA Clinical Research Unit Hematology/Oncology
Santa Monica, United States
Rocky Mountain Cancer Centers (RMCC) - Boulder
Boulder, United States
St. Mary's Hospital and Regional Medical Center - St. Mary's
Grand Junction, United States
Cancer Specialists of North Florida
Fleming Island, United States
Florida Cancer Specialists & Research Institute (FCS) - Fort Myers Cancer Center
Fort Myers, United States
Mayo Clinic
Jacksonville, United States
Florida Cancer Affiliates/Ocala Oncology - Clinic
Ocala, United States

+192 more sites — see the official record for the full list.

Common questions

What is follicular lymphoma?

Follicular lymphoma is a type of blood cancer that affects certain white blood cells called lymphocytes.

What does 'relapsed/refractory' mean for my cancer?

'Relapsed' means your cancer has come back after treatment, and 'refractory' means your cancer hasn't responded to treatment.

What is a 'placebo'?

A placebo is an inactive or 'dummy' tablet that looks just like the real drug but contains no active medicine. It's used for comparison in studies.

Will I know if I'm getting the new drug or the placebo?

In this type of study, participants usually don't know whether they are receiving the active study drug or the placebo. This helps ensure fair results.

How long will the study last for me?

Treatment cycles are 28 days, and after 12 cycles, ongoing maintenance treatment may occur. You'll be followed up for up to 5 years after the last person joins the study.