Active not recruitingPHASE1, PHASE2INTERVENTIONAL

A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab + Lenalidomide (+Len), and the Safety, Tolerability, and Pharmacokinetics of SC Versus IV Mosunetuzumab + Len in Participants With Follicular Lymphoma

This study is investigating new treatment options for follicular lymphoma, a type of slow-growing cancer that affects white blood cells. Researchers are looking into a combination of two drugs, mosunetuzumab and lenalidomide, to see how safe they are, if they help patients, and how the body uses them. The study aims to understand if giving mosunetuzumab in different ways (either into a vein or as an injection under the skin) makes a difference in terms of how well it works and how the body handles it. This research is important for finding better ways to treat follicular lymphoma, especially for those whose previous treatments haven't worked or who need treatment for the first time.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Hoffmann-La Roche

Enrolment target

237

Start

12 Aug 2020

Estimated completion

06 Sep 2030

Follicular Lymphoma

What is this study about?

This study is about exploring new and potentially better ways to treat follicular lymphoma. Follicular lymphoma is a type of cancer that starts in white blood cells called lymphocytes. It's often slow-growing, but it does need treatment. The study is focusing on two medicines used together: mosunetuzumab and lenalidomide.

The main goals of the study are to understand a few key things. Firstly, how safe is this combination of medicines? Doctors always want to make sure new treatments don't cause too many serious side effects. Secondly, does this combination work well against the lymphoma? They'll be looking to see if it shrinks the cancer or stops it from growing. Thirdly, they want to understand how the body uses and processes these medicines.

An important part of this study is comparing two different ways of giving mosunetuzumab: either directly into a vein (this is called intravenous or IV) or as an injection just under the skin (this is called subcutaneous or SC). The researchers want to see if one way is more effective, safer, or easier for patients. This kind of research helps doctors find the best possible treatments and ways to give them to people with follicular lymphoma.

Key takeaways

This study is testing new drug combinations for follicular lymphoma.
It aims to find out if these treatments are safe and effective.
Researchers are comparing two different ways to give one of the drugs: into a vein or as an injection under the skin.
The study includes patients with previously treated and untreated follicular lymphoma.
Your doctor will need to check many health requirements to see if you can join.

Who may be eligible?

To join this study, people generally need to have follicular lymphoma that has either come back or not responded to at least one previous treatment, including treatments involving immunotherapy or chemotherapy. There's also a group of people who have never been treated before for their follicular lymphoma but need treatment due to how serious their disease is.

Your lymphoma must be confirmed by tests to be Grade 1, 2, or 3a, and it must have a specific marker called CD20. Doctors will also need to see that your lymphoma lights up on a special scan called a PET scan, and that there's at least one clear area of lymphoma that can be measured accurately. You also need to be generally well enough to take part, with normal blood test results (unless they are affected by your lymphoma).

There are also some important safety requirements. For instance, women who could become pregnant must agree to use effective contraception throughout the study. Your doctor will carefully check all the requirements to see if this study is suitable for you.

Quick self-check

Do you have follicular lymphoma that needs treatment?
Has your lymphoma been confirmed to be CD20 positive?
Are you generally well and active?
Do your blood tests show good organ function (unless your lymphoma affects them)?
Are you able to use reliable contraception if you could become pregnant?

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

What does participation involve?

Taking part in this study would involve regular visits to the hospital or clinic. During these visits, you'd have physical exams, blood tests, and scans (like PET-CT scans) to monitor your health and how the treatment is working. You would receive the study medications, mosunetuzumab and lenalidomide, either into a vein or as an injection under the skin, depending on which group you are in.

The frequency of visits and tests would be scheduled by the study team. You would also have follow-up appointments after your treatment finishes to continue monitoring your health and the long-term effects of the drugs. The total length of your participation would depend on your response to treatment and the study's follow-up plan.

Potential risks and benefits

Participating in this study might offer potential benefits, such as access to new treatments for follicular lymphoma that are not yet widely available. There's a chance these treatments could help control your lymphoma. However, like all medicines, the study drugs could have side effects, which the study team will monitor closely. You will be given detailed information about these potential risks. Remember, taking part in any clinical trial is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (26)

City of Hope National Medical Center
Duarte, United States
University of Miami Miller School of Medicine
Miami, United States
Norton Cancer Institute - St. Matthews
Louisville, United States
Mary Bird Perkins Cancer Ctr
Baton Rouge, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, United States
Duke University Medical Center
Durham, United States
Fairview Hospital
Cleveland, United States
Cleveland Clinic
Cleveland, United States
Hillcrest Hospital
Mayfield Heights, United States
Rhode Island Hematology/Oncology Program
Woonsocket, United States
Tennessee Oncology;Chattanooga Oncology & Hematology Associates
Chattanooga, United States
Tennessee Oncology PLLC - Franklin
Franklin, United States

+14 more sites — see the official record for the full list.

Common questions

What is follicular lymphoma?

Follicular lymphoma is a common type of slow-growing cancer that affects certain white blood cells in your body.

What are mosunetuzumab and lenalidomide?

These are two different medicines being tested together in this study as a potential treatment for follicular lymphoma.

Why are doctors giving the medicine in two different ways?

Researchers want to find out if giving mosunetuzumab into a vein or as an injection under the skin changes how well it works or how your body handles it.

Who can join this study?

The study is looking for adults with follicular lymphoma who have had some previous treatment or who need treatment for the first time. There are strict rules about who can take part based on your health and lymphoma details.

What does 'pharmacokinetics' mean?

This is a scientific term that means how your body takes in, distributes, breaks down, and gets rid of a medicine. It helps doctors understand the right dose.