Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

A Phase I/II Trial of Mosunetuzumab (BTCT4465A) as Consolidation Therapy in Patients with Diffuse Large B-Cell Lymphoma following First-Line Immunochemotherapy and as Monotherapy or In Combination With Polatuzumab Vedotin in Elderly/Unfit Patients with Previously Untreated Diffuse Large B-Cell Lymphoma

This research study is investigating new treatments for people with Diffuse Large B-Cell Lymphoma (DLBCL), a common type of blood cancer. If you're an elderly or less fit patient who hasn't been treated for DLBCL before, the study is testing mosunetuzumab alone or combined with polatuzumab vedotin. For other patients who have already had standard treatment (immunochemotherapy), the study looks at mosunetuzumab as a 'consolidation' therapy to help prevent the cancer from returning. The main goals are to find out how effective these treatments are at shrinking or controlling the cancer and to understand any side effects they might cause. This will help doctors learn more about improving care for DLBCL patients.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

F. Hoffmann-La Roche AG

Enrolment target

Start

01 Apr 2024

Diffuse Large B-Cell Lymphoma (DLBCL)

What is this study about?

This study is focused on a specific type of blood cancer called Diffuse Large B-Cell Lymphoma, or DLBCL. It's a common and fast-growing lymphoma, and doctors are always looking for better ways to treat it. This new research is particularly interested in a drug called mosunetuzumab, sometimes used alone and sometimes combined with another medicine called polatuzumab vedotin (also known as Polivy).

There are a couple of different groups of patients being looked at in this study. For some patients, especially those who are older or less well and haven't had treatment for their DLBCL before, the study is testing whether mosunetuzumab, by itself or with polatuzumab vedotin, can effectively treat their cancer. For another group of patients who have already had standard initial treatment (called immunochemotherapy) and are doing well, the study will see if mosunetuzumab can be used as an extra 'consolidation' treatment to help keep the cancer away for longer.

The main things the researchers want to find out are how well these treatments work – by seeing if they shrink the cancer or make it disappear – and what side effects they might have. They will also look at how long the treatment keeps the cancer under control and how it affects patients' overall quality of life, including their physical abilities and energy levels. This information is crucial for doctors to decide if these new treatments could be helpful for future patients with DLBCL.

Key takeaways

This study explores new treatments for Diffuse Large B-Cell Lymphoma (DLBCL).
It tests mosunetuzumab alone or with polatuzumab vedotin.
Aims to check how well the drugs work and their side effects.
Includes patients who haven't had treatment and those after initial therapy.
Involves regular scans, blood tests, and quality of life questionnaires.

Who may be eligible?

This study is for adults aged 18 and over, both men and women, who have Diffuse Large B-Cell Lymphoma (DLBCL).

To be considered, you'd need to fit into one of the specific groups mentioned: either you haven't received any treatment for your DLBCL yet and are considered elderly or less strong, or you've already had your initial standard treatment (called immunochemotherapy) and your cancer is currently under control.

There will be other detailed health checks to make sure this study is safe and right for you. Your doctor will be able to discuss these with you, as well as any reasons why you might not be able to participate, such as other medical conditions or medications you are taking.

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 old or older?
Do you have Diffuse Large B-Cell Lymphoma (DLBCL)?
Have you not received any prior treatment for DLBCL, OR have you completed your initial standard treatment (immunochemotherapy)?
Are you able to attend regular hospital visits and appointments?
Are you willing to have regular scans and blood tests?
Are you interested in participating in a clinical research study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive either mosunetuzumab, another drug called polatuzumab vedotin, or a combination of both. These drugs are given through an infusion, which means they go directly into your bloodstream, or sometimes as an injection under the skin. You will have regular appointments for check-ups and to receive your treatment.

Throughout the study, you will have various tests, including PET-CT scans, which are special scans to see if the cancer is responding to the treatment. Blood tests will also be taken regularly to check how your body is reacting to the medicines. Researchers will also ask you to complete questionnaires about your quality of life, focusing on how you feel physically and your energy levels.

The exact number of visits, tests, and the total length of your participation will vary depending on which treatment group you are in and how you respond. There will also be follow-up appointments after your treatment finishes to monitor your health and any long-term effects.

Potential risks and benefits

Taking part in this study might offer a potential benefit by giving you access to new treatments for DLBCL that are not yet widely available. These treatments could help control your cancer. However, like all medicines, the study drugs may cause side effects, which can range from mild to serious. The research team will closely monitor you for any side effects and provide care for them. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

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Unverified
Spain
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Unverified
Poland

Common questions

What is Diffuse Large B-Cell Lymphoma (DLBCL)?

DLBCL is a fast-growing type of cancer that affects a type of white blood cell called B-lymphocytes. It's the most common type of non-Hodgkin lymphoma.

What are 'Phase I' and 'Phase II' studies?

Phase I studies primarily check if a new treatment is safe and to find a suitable dose. Phase II studies then look at how well the treatment works for a specific condition and continue to monitor safety.

What is mosunetuzumab?

Mosunetuzumab is a type of targeted drug designed to help your immune system fight cancer cells more effectively.

What is polatuzumab vedotin?

Polatuzumab vedotin is another targeted drug that delivers a powerful anti-cancer medicine directly to the cancer cells.

Will I know which treatment I'm getting?

The study design will determine this. In some parts of the study, you might get a specific drug, while in others, it might be a combination. The study team will explain this fully.