Active not recruitingPHASE1, PHASE2INTERVENTIONAL

A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in B-Cell Non-Hodgkin Lymphoma

This study is investigating new treatment combinations for certain types of B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and mantle cell lymphoma (MCL). The main goal is to find out how safe these new combinations are and how well they work for patients whose cancer has come back or hasn't responded to previous treatments. We are testing Mosunetuzumab, given either directly into the vein (IV) or under the skin (SC), in combination with Polatuzumab vedotin. For people with DLBCL and FL, this study is for those who have tried at least one other treatment before. For MCL, it's for those who have had at least two previous treatments. We hope to find better ways to treat these cancers.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Hoffmann-La Roche

Enrolment target

422

Start

25 Sep 2018

Estimated completion

20 Jul 2025

B-cell Non-Hodgkin Lymphoma

What is this study about?

This research study is about exploring new ways to treat specific types of B-cell non-Hodgkin lymphoma. These include diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and mantle cell lymphoma (MCL). For many people, existing treatments work well, but sometimes the cancer can come back or doesn't respond as expected. When this happens, doctors look for new options.

In this study, we are testing different combinations of medicines called Mosunetuzumab and Polatuzumab vedotin. Mosunetuzumab is being given in two ways: either directly into a vein (like a drip) or as an injection under the skin. The main aims are to understand how safe these new combinations are for patients and how effective they are in fighting the cancer. The first part of the study helps us find the right dose, and then more patients will join to further test how well it works.

This study is especially for patients whose lymphoma has either come back after previous treatments or hasn't responded to initial therapies. For DLBCL and FL, this typically means you've had at least one other treatment. For MCL, it means you've had at least two different treatments, including a specific type of drug and chemotherapy. We hope that the information gathered from this study will help us develop more effective and long-lasting treatments for these types of lymphoma in the future.

Key takeaways

Tests new drug combinations for certain lymphomas.
Aims to find safe and effective treatments for relapsed/refractory lymphoma.
Involves two drugs: Mosunetuzumab (IV or SC) and Polatuzumab vedotin (IV).
For patients whose lymphoma has come back or hasn't responded to other treatments.
Requires regular hospital visits and health monitoring.

Who may be eligible?

To join this study, you would generally need to be an adult (18 years or older) and have certain types of B-cell non-Hodgkin lymphoma (such as follicular lymphoma, diffuse large B-cell lymphoma, or mantle cell lymphoma) that has either come back or not responded well to previous treatments. You would also need to be well enough to take part, meaning you can carry out most daily activities, and your blood, kidney, and liver tests should be within a healthy range. Your cancer also needs to be measurable, meaning doctors can see and track it.

There are also some reasons why you might not be able to join. For example, if you've already had this specific study medicine (Mosunetuzumab or Polatuzumab vedotin) or similar types of drugs, or if you have certain nerve problems. You also can't have had other cancer treatments, including chemotherapy, radiotherapy, or certain types of stem cell or CAR T-cell therapy, too close to the start of this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Do you have diffuse large B-cell, follicular, or mantle cell lymphoma?
Has your lymphoma come back or not responded to previous treatments?
Are you generally well and able to do most daily activities?
Have you *not* had these specific study drugs (Mosunetuzumab or Polatuzumab vedotin) before?
Have you *not* had similar anti-cancer treatments very recently?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the hospital for checks, blood tests, and to receive your study medication, which will be given either into a vein or as an injection under the skin. You'll also have scans to see how the treatment is working. The study begins with finding the right dose for the medications, followed by a longer period to see the full effects. The total duration of your participation would depend on how your body responds to the treatment and the stage of the study you are in, but it will involve ongoing assessments and follow-up to monitor your health and the cancer. Your study doctor and nurse will explain the schedule in detail.

Potential risks and benefits

Like all medical studies, there are potential benefits and risks to consider. A potential benefit is that you might have access to a newer treatment combination that could help slow down or shrink your cancer, especially if other treatments haven't worked. However, there are also risks, as new medications can cause side effects, which your study team will monitor closely. You will be given detailed information about these. It's important to remember that you can decide to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (29)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of Alabama at Birmingham School of Medicine
Verified postcode
Birmingham, United States
City of Hope
Verified postcode
Duarte, United States
University of Colorado Hospital - Anschutz Cancer Pavilion
Verified postcode
Aurora, United States
University of Miami Miller School of Medicine
Verified postcode
Miami, United States
Moffitt Cancer Center
Verified postcode
Tampa, United States
University of Michigan Hospital
Verified postcode
Ann Arbor, United States
Karmanos Cancer Institute
Verified postcode
Detroit, United States
New York University Langone Medical Center
Verified postcode
New York, United States
Levine Cancer Institute
Verified postcode
Charlotte, United States
Penn State Milton S. Hershey Medical Center
Verified postcode
Hershey, United States
Fox Chase Cancer Center
Verified postcode
Philadelphia, United States
University of Pittsburgh - Hillman Cancer Center
Verified postcode
Pittsburgh, United States

Common questions

What is B-cell non-Hodgkin lymphoma?

It's a type of cancer that starts in white blood cells called B-cells. These cells are part of your body's immune system.

What does 'relapsed or refractory' mean?

Relapsed means your cancer came back after treatment. Refractory means your cancer didn't respond or stopped responding to treatment.

How will the study drugs be given?

One of the study drugs, Mosunetuzumab, will be given either into a vein (like a drip) or as an injection under the skin. The other drug, Polatuzumab vedotin, is usually given into a vein.

Will I get to choose which way Mosunetuzumab is given?

This will depend on the part of the study you join and what the study doctors decide is best for you, based on the research plan.

What happens if I decide I don't want to be in the study anymore?

You are free to leave the study at any time. This decision won't affect your regular medical care.