Active not recruitingPHASE2INTERVENTIONAL

Rituximab in Combination With Glofitamab and Polatuzumab Vedotin in Patients With Previously Untreated Aggressive B-cell Lymphoma Ineligible for R-CHOP

This research is looking at a new way to treat aggressive B-cell lymphoma, a type of cancer that starts in white blood cells. It's for patients who are elderly or not healthy enough for the usual strong chemotherapy, and who haven't had treatment for their lymphoma yet. The study is testing a combination of three medicines: Rituximab, Polatuzumab vedotin, and Glofitamab. Doctors want to see if this 'chemotherapy-light' approach is safe, works well, and could be a good option for these patients. The results will help decide if this new combination should be studied further.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Enrolment target

125

Start

20 Mar 2023

Estimated completion

28 Feb 2028

Lymphoma, Large B-Cell, Diffuse

What is this study about?

This study is about finding better treatments for a type of cancer called aggressive B-cell lymphoma. This cancer affects certain white blood cells in your body. Usually, patients with this condition receive strong chemotherapy, but some people, especially those who are older or have other health issues, might not be able to handle such intense treatment.

That's where this study comes in. It's testing a new approach, which we're calling 'R-Pola-Glo.' This isn't traditional chemotherapy but a combination of three newer medicines: rituximab, polatuzumab vedotin, and glofitamab. These drugs work in different ways to target and fight cancer cells. The main goal is to see if this gentler combination can be an effective and safe option for patients who haven't been treated before and can't receive the standard strong chemotherapy.

The information gathered from this study will help doctors understand how well this new combination works, if it has any side effects, and if it's a good path to explore for future treatments. It's an important step in trying to improve care for patients who need different treatment choices.

Key takeaways

This study tests a new, gentler treatment for aggressive B-cell lymphoma.
It's for patients over 60 or those not fit for strong chemotherapy.
The treatment uses a combination of three new medicines.
The aim is to find effective options with fewer side effects.
Participation involves regular checks and tests to monitor your health.

Who may be eligible?

This study is specifically designed for people with an aggressive form of B-cell lymphoma who haven't received any treatment for it yet. You must be over 60 years old and your general health means that the standard, strong chemotherapy isn't the best option for you. Doctors will need to confirm your diagnosis based on special tests, and your cancer must be visible on a special scan.

There are also some important health checks you'll need to pass. Your liver, kidney, and blood count functions must be working well enough. You'll also be checked for certain infections like Hepatitis B, C, HIV, and current COVID-19, and these must be negative. Women who could become pregnant and men with female partners who could become pregnant will need to use effective birth control during the study.

Some conditions would prevent you from joining. For example, if you have chronic lymphocytic leukaemia, you wouldn't be able to take part. The study team will review all your medical information carefully to see if this study is right for you.

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 over 60 years old?
Do you have aggressive B-cell lymphoma?
Have you *not* had any treatment for your lymphoma yet?
Has your doctor said you're not suitable for standard strong chemotherapy?
Are you willing and able to follow the study's requirements?
Are your kidney, liver, and blood counts generally healthy?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive a combination of three study medicines: Rituximab, Polatuzumab vedotin, and Glofitamab. The specific schedule and how these medicines are given will be explained by the study team. You'll have regular hospital visits for treatments, blood tests, and check-ups to monitor your health and how you're responding to the treatment.

Throughout the study, you'll undergo scans and other tests to see how the treatment is affecting your lymphoma. The precise number of visits and tests will be detailed by the study team, but they are essential for your safety and to understand the treatment's effectiveness. After your treatment period, there will be a follow-up phase where you'll continue to have check-ups to monitor your long-term health. The total duration of your involvement, including follow-up, will be clearly explained by the study doctor.

Potential risks and benefits

Participating in a study like this might offer you access to a new treatment combination that isn't widely available yet, which could potentially help your lymphoma. However, like all medicines, these study drugs can have side effects. The study team will carefully monitor you for any side effects and manage them as best as possible. You will receive detailed information about potential risks. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (28)

Uniklinik Innsbruck
Verified postcode
Innsbruck, Austria
Kepler Universitätsklinikum
Verified postcode
Linz, Austria
Ordensklinikum Linz - Barmherzige Schwestern
Verified postcode
Linz, Austria
Ordensklinikum Linz - Elisabethinen
Verified postcode
Linz, Austria
Landeskrankenhaus Salzburg Universitätsklinikum der Paracelsus Medizinischen Privatuniversität
Verified postcode
Salzburg, Austria
Univ. Klinikum St. Pölten
Verified postcode
Sankt Pölten, Austria
AKH Meduni Wien
Verified postcode
Vienna, Austria
Hanusch Krankenhaus
Verified postcode
Vienna, Austria
Universitätsklinikum Magdeburg
Verified postcode
Magdeburg, Germany
Charité - Universitätsmedizin Berlin
Verified postcode
Berlin, Germany
HELIOS Klinikum Berlin-Buch
Verified postcode
Berlin, Germany
Medizinisches Universitätsklinikum Knappschaftskrankenhaus Bochum
Verified postcode
Bochum, Germany

Common questions

What is 'aggressive B-cell lymphoma'?

It's a fast-growing cancer that starts in specific white blood cells in your immune system called B-cells.

What does 'ineligible for R-CHOP' mean?

It means the standard strong chemotherapy (R-CHOP) isn't suitable for you, perhaps because of your age or other health conditions.

Are the study drugs chemotherapy?

No, they're a 'chemotherapy-light' combination of newer medicines that target cancer cells in different ways, not traditional chemotherapy.

Will I still get my regular care from my doctor?

Yes, you will continue to receive good medical care from the study team and your regular doctors.

How long will I be involved in the study?

The study involves treatment and then a follow-up period. The exact length will be explained by the study team.