Active not recruitingPHASE3INTERVENTIONAL

A Study Evaluating the Efficacy and Safety of Mosunetuzumab in Combination With Lenalidomide in Comparison to Rituximab in Combination With Lenalidomide With a US Extension of Mosunetuzumab in Combination With Lenalidomide in Participants With Follicular Lymphoma

This research study is for people with a type of cancer called follicular lymphoma. This is when the lymphoma has either returned after initial treatment or hasn't responded well to previous medicines. The study wants to find out if a new drug, called mosunetuzumab, works better and is safer when combined with another drug, lenalidomide, compared to a standard treatment which uses rituximab alongside lenalidomide. Both combinations aim to help manage the lymphoma. Researchers will carefully check how well these treatments work in shrinking the lymphoma and how patients feel while taking them. The goal is to see if the new combination could be a good option for future follicular lymphoma treatment.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Hoffmann-La Roche

Enrolment target

478

Start

27 Oct 2021

Estimated completion

31 Dec 2029

Relapsed or Refractory Follicular Lymphoma

What is this study about?

Follicular lymphoma is a type of cancer that affects a part of your blood called lymphocytes. Sometimes, after initial treatment, this lymphoma can come back or not be fully controlled by the medicines given. When this happens, doctors call it 'relapsed or refractory' follicular lymphoma.

This study is designed to explore new treatment options for people in this situation. It focuses on two different drug combinations. One combination uses a new, investigational drug called mosunetuzumab, together with lenalidomide. The other combination uses rituximab, which is a more established treatment, also with lenalidomide. The main purpose of the study is to compare these two combinations. Researchers want to understand which combination is more effective at treating the lymphoma and which causes fewer side effects.

Participation could help improve future treatments for follicular lymphoma. By comparing these two approaches, doctors hope to gain valuable information that could lead to better outcomes for people living with this type of cancer in the future. Your involvement could contribute significantly to this understanding.

Key takeaways

This study explores new and standard treatments for follicular lymphoma that has returned or not responded to previous therapy.
It compares two drug combinations: mosunetuzumab + lenalidomide versus rituximab + lenalidomide.
The main goals are to check how effective and safe these treatments are.
You would have regular check-ups, blood tests, and scans.
Taking part involves strict adherence to guidelines, especially on preventing pregnancy.
Your participation could help improve future treatments for follicular lymphoma.

Who may be eligible?

To be able to join this study, you would need to meet certain conditions. Firstly, you must have been diagnosed with follicular lymphoma that has either come back after past treatments or hasn't responded to them. Your doctors would need to confirm that your lymphoma contains a specific marker called CD20+.

You should generally be well enough to take part in a study like this. Your doctor will assess your overall health and how active you are on a daily basis. You must have received at least one previous treatment for your lymphoma, which might have included chemotherapy or other targeted therapies. Also, doctors will need to look at a small sample of your lymphoma tissue, either a recent biopsy or an older sample if a new one isn't possible, to ensure it's still follicular lymphoma.

There are also specific requirements about pregnancy prevention due to some of the medications involved. If you are a woman who could become pregnant, you would need to use highly effective contraception and agree not to donate eggs. Men taking part would also need to agree to similar measures regarding contraception and not donating sperm.

Quick self-check

Do you have follicular lymphoma that has come back or not responded to past treatments?
Have you received at least one previous treatment for your lymphoma?
Are you generally well and able to carry out your daily activities?
Are you willing to provide a tissue sample of your lymphoma?
Are you willing to follow strict pregnancy prevention rules, if applicable?
Are you at least 18 years old?

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 in this study, you would receive one of the two treatment combinations. This means you would be given either mosunetuzumab plus lenalidomide, or rituximab plus lenalidomide. The specific schedule for how often you receive these medicines and for how long would be decided by the study doctors.

Throughout the study, you would have regular visits to the clinic. During these visits, doctors and nurses would perform various checks. This would include physical examinations, blood tests, and scans to see how well the treatment is working and to monitor for any side effects. You would also be asked to report how you are feeling and any symptoms you experience.

There would also be very strict guidelines, especially regarding pregnancy prevention, that you would need to follow if you are capable of having children. After your main treatment period ends, you would continue to have follow-up appointments for a period, which could be up to 12 months in some cases, to monitor your health and the long-term effects of the treatment. The total duration of your participation in the study, including follow-up, could vary.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as access to a new treatment option that is not yet widely available, and close medical monitoring. However, there are also potential risks. All medications can cause side effects, which can range from mild to serious, and some effects of new drugs might not be fully known. Your doctor will discuss all known potential side effects with you before you decide to join. It is very important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (112)

City of Hope Comprehensive Cancer Center
Duarte, United States
Winship Cancer Institute
Atlanta, United States
Fort Wayne Medical Oncology and Hematology, Inc
Fort Wayne, United States
Investigative Clinical Research of Indiana, LLC
Noblesville, United States
Johns Hopkins Uni
Baltimore, United States
University of Michigan Health System
Ann Arbor, United States
Cancer & Hematology Center of West Michigan
Grand Rapids, United States
Washington University
St Louis, United States
NYU Long Island Hospital
Mineola, United States
NYU Langone Ambulatory Care Center
New York, United States
Montefiore Medical Center - Montefiore Medical Park
The Bronx, United States
Montefiore Medical Center
The Bronx, United States

+100 more sites — see the official record for the full list.

Common questions

What is follicular lymphoma?

Follicular lymphoma is a slow-growing type of cancer that affects white blood cells called lymphocytes.

What does 'relapsed or refractory' mean?

It means the lymphoma has either come back after initial treatment or hasn't responded well to previous medicines.

What drugs are being tested?

The study is comparing two combinations: mosunetuzumab with lenalidomide, and rituximab with lenalidomide.

Will I know which treatment I'm getting?

In this type of study, you might not know which specific treatment combination you are receiving; it's decided by chance.

How long will I be in the study?

Your involvement could last for several months or longer, including treatment and follow-up appointments.