Active not recruitingPHASE3INTERVENTIONAL

An Open-Label Study Comparing Glofitamab and Polatuzumab Vedotin + Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma

This research study is for people recently diagnosed with a type of blood cancer called large B-cell lymphoma, who haven't received treatment yet. The main goal is to see if a new medicine, glofitamab, when given with other established medicines (Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone – often shortened to Pola-R-CHP), is more effective and safer than just Pola-R-CHP alone. Researchers want to understand how well glofitamab works, what side effects it might have, and if it could be a better option for treating this specific type of lymphoma. This is an important step in finding improved treatments for patients.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Hoffmann-La Roche

Enrolment target

1,130

Start

18 Sep 2023

Estimated completion

30 Oct 2030

Large B-Cell Lymphoma

What is this study about?

This study is looking into a new way to treat a type of cancer called large B-cell lymphoma (LBCL). If you or someone you know has been diagnosed with LBCL and hasn't started treatment yet, this study might be relevant. Large B-cell lymphoma is a cancer that affects white blood cells, and finding the most effective treatments is really important.

The main aim of this study is to compare two treatment approaches. One approach uses a combination of medicines that doctors already use, called Pola-R-CHP. The other approach adds a new medicine, called glofitamab, to this standard Pola-R-CHP treatment. By comparing these two groups, doctors want to find out if adding glofitamab makes the treatment work better or helps more people.

Researchers will carefully check how well each treatment works, how safe it is, and what side effects people experience. Learning more about new medicines like glofitamab could lead to better outcomes for people with large B-cell lymphoma in the future, offering more hope and choice in their treatment journey.

Key takeaways

This study compares a new treatment (glofitamab + Pola-R-CHP) with a standard treatment (Pola-R-CHP) for untreated large B-cell lymphoma.
It aims to see if the new combination is more effective or safer.
Participants must be 18-80 years old and newly diagnosed.
Regular clinic visits, tests, and medication administration are part of participation.
Potential benefits include access to a new treatment, but there are also known and unknown risks.
Your enrolment is voluntary, and you can withdraw at any time.

Who may be eligible?

To be part of this study, you would generally need to be an adult between 18 and 80 years old and have been recently diagnosed with large B-cell lymphoma that hasn't been treated before. Your medical team would also need to confirm that your cancer cells have a specific marker called CD20. You'd also need to be able to provide a sample of your tumour tissue for analysis.

There are also some health checks to make sure you're well enough to take part. For example, your heart should be working well, and your blood test results need to be within certain limits. You'd also need certain routine infection tests, such as for HIV and COVID-19.

However, you wouldn't be able to join if you've had a solid organ transplant, or if you're sensitive or allergic to any of the medicines used in the study. Certain other health conditions, like severe nerve problems or some other types of lymphoma, would also mean you couldn't participate, as would taking certain immune-suppressing medicines close to the start of the study.

Quick self-check

I am between 18 and 80 years old.
I have recently been diagnosed with large B-cell lymphoma and haven't had treatment for it yet.
My doctors confirm my cancer has the CD20 marker.
I am generally healthy enough for treatment, with good heart and blood test results.
I do not have certain other serious health problems or types of lymphoma.
I am not currently taking medicines that suppress my immune system (e.g., cyclosporin, azathioprine).

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

What does participation involve?

If you join this study, you will receive either the standard Pola-R-CHP treatment, or glofitamab along with Pola-R-CHP. This will involve regular visits to the clinic for your treatments, which are given through a drip (intravenous infusion). You'll have various tests and check-ups during these visits, including blood tests, scans (like CT or MRI), and heart health checks, to monitor your health and how the treatment is working.

Your study doctor will explain the exact schedule for your treatments and appointments. There will be an initial period of more frequent visits, followed by a longer follow-up period where visits might be less frequent, but you would still be monitored for several years. The total length of your participation would depend on how your treatment progresses, but active treatment could last for several months, with ongoing monitoring after that.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit could be access to a new treatment (glofitamab) that might be more effective than standard treatment. However, there's no guarantee the treatment will work for you, and it may not be better than existing options. There are risks of side effects from all the medications involved, which your doctor will explain in detail. These can range from mild to serious and will be carefully monitored. You will be provided with detailed information about all possible side effects. It’s very important to remember that participating in this study is completely voluntary, and you have the right to withdraw at any time, for any reason, without it affecting your future medical care.

Locations (229)

Alaska Oncology & Hematology, LLC
Anchorage, United States
Kaiser Permanente - Anaheim (E. La Palma)
Anaheim, United States
University of California, San Francisco-Fresno
Clovis, United States
City of Hope National Medical Center
Duarte, United States
City of Hope - Lennar Foundation Cancer Center
Irvine, United States
Valkyrie Clinical Trials
Los Angeles, United States
UCLA Jonsson Comprehensive Cancer Center
Los Angeles, United States
Kaiser Permanente - Roseville
Roseville, United States
Kaiser Permanente - Santa Clara
Santa Clara, United States
Stanford Univ School of Med
Stanford, United States
Kaiser Permanente Medical Ctr
Vallejo, United States
University of Colorado Cancer Center
Aurora, United States

+217 more sites — see the official record for the full list.

Common questions

What is large B-cell lymphoma?

It's a type of cancer that affects white blood cells called lymphocytes, specifically B-cells, and it grows relatively quickly.

What is the new medicine, glofitamab?

Glofitamab is an experimental drug designed to help your immune system find and fight cancer cells more effectively.

Will I know if I'm getting the new medicine?

This study is 'open-label', meaning both you and your study doctor will know which treatment you are receiving.

How long will I be in the study?

The active treatment phase could last several months, but you'll be monitored for a longer period, possibly several years, to see the lasting effects of the treatment.

Can I leave the study at any time?

Yes, you are free to leave the study at any point, and your decision won't affect the care you receive from your doctors.