All studies
Active not recruitingPHASE2INTERVENTIONAL

A Study to Evaluate the Safety and Efficacy of Glofitamab in Combination With Rituximab (R) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Circulating Tumor (ct)DNA High-Risk Patients With Untreated Diffuse Large B-Cell Lymphoma

This study is testing a new treatment called Glofitamab alongside a common treatment for a cancer called Diffuse Large B-Cell Lymphoma (DLBCL). This type of lymphoma affects white blood cells. Researchers want to see how safe and effective this new combination is for people who have DLBCL for the first time and have a 'high-risk' form identified by a blood test. The study will look at whether Glofitamab helps to shrink the cancer and if it causes any unwanted side effects. It's a Phase II study, meaning it's still in the early stages of testing, and it involves several hospitals. The goal is to find better ways to treat this specific type of lymphoma.

At a glance

Status
Active not recruiting
Phase
PHASE2
Sponsor
Hoffmann-La Roche
Enrolment target
46
Start
22 Mar 2022
Estimated completion
30 Sep 2026

What is this study about?

This study is looking into a new treatment approach for a type of blood cancer called Diffuse Large B-Cell Lymphoma, often shortened to DLBCL. In DLBCL, certain white blood cells called B-cells grow in an uncontrolled way. This study focuses on people who have never been treated for their DLBCL before and who have a 'high-risk' version of the disease, which is found through a special blood test. The standard treatment for DLBCL often involves a combination of drugs called R-CHOP. In this study, we're adding a new drug, Glofitamab, to the R-CHOP treatment to see if it can improve how well patients respond to treatment and if it's safe to use.

The main purpose of this study is to carefully check the safety of adding Glofitamab to the standard R-CHOP treatment. This means doctors will be watching closely for any side effects or unwanted reactions. We also want to find out how effective this new combination is at treating the DLBCL, for example, by seeing if it helps to shrink the cancer. The study will also look at how Glofitamab moves through your body, which helps scientists understand the best way to give the medicine.

By taking part, you could contribute to developing new and potentially better ways to treat DLBCL, especially for those with a high-risk form of the disease. This is a Phase II study, which means it's an important step in researching new treatments, but it's not yet approved as a standard treatment. We hope the information gathered will help us understand if this new combination could become an option for future patients.

Key takeaways

  • This study is for adults with newly diagnosed, high-risk DLBCL.
  • It combines a new drug (Glofitamab) with standard R-CHOP treatment.
  • The main goals are to check for safety and how well the treatment works.
  • Participation involves regular hospital visits, medicines, and tests.
  • You can stop participating at any time if you wish.
  • This is an early-stage study, not a widely approved treatment yet.

Who may be eligible?

To be able to join this study, you would need to be an adult, aged 18 or older, who has recently been diagnosed with a specific type of DLBCL and has not had any treatment for it yet. Your doctor would need to confirm that your type of lymphoma fits the study criteria, including if it's 'CD20-positive'. You would also need to be generally well enough to take part, as assessed by a common health check. An important part of checking if you can join is a special blood test that looks for 'circulating tumour DNA' – if this test shows you are 'high-risk', you might be a good fit.

Other health checks are also needed. For instance, your heart needs to be strong enough, and other blood tests would show that your blood is healthy enough to start treatment. You would also need to have at least one measurable area of lymphoma that doctors can track. For women who could become pregnant and men who could father a child, it's important to be using effective contraception during the study. You would also need to be expected to live for at least six more months.

However, some things would mean you couldn't join. For example, if you have a different type of lymphoma that doesn't fit the study's focus, or if you have certain other health conditions that would make the treatment unsafe for you. If you have any allergies to the drugs used in the study, or if you've already had certain strong anti-cancer drugs, you wouldn't be able to participate.

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.

  1. Are you 18 years old or older?
  2. Have you recently been diagnosed with DLBCL and not yet received treatment?
  3. Has your doctor told you that your DLBCL is 'CD20-positive' and potentially 'high-risk' based on blood tests?
  4. Are you generally well and able to manage daily activities without much difficulty?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive regular medical care and tests. This will involve appointments at the hospital or clinic, where you will have examinations, blood tests, and scans (like PET/CT scans) to monitor your health and how the treatment is working. You will receive the study medications, which include Glofitamab and the standard R-CHOP drugs, given through injections or drips. The doctors and nurses will explain exactly how these are given and how often.

The study involves several treatment cycles. During this time, you'll have ongoing assessments to check for any side effects and to see how your lymphoma is responding. After your main treatment period, there will be follow-up appointments to continue monitoring your health over a longer period. The total duration of your participation, including follow-up, will be explained by the study team, but it typically lasts for many months or even longer.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new treatment (Glofitamab) that could be more effective than standard treatment alone for your high-risk lymphoma. You will also receive very close medical care and monitoring throughout the study. However, like all medical treatments, there are potential risks and side effects from the medications used, including those from Glofitamab and the standard R-CHOP drugs. These side effects can vary greatly from person to person and will be discussed in detail by the study team. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (18)

  • City of Hope Comprehensive Cancer Center
    Verified postcode
    Duarte, United States
  • Stanford Cancer Center
    Verified postcode
    Stanford, United States
  • University of Iowa
    Verified postcode
    Iowa City, United States
  • Washington University; Wash Uni. Sch. Of Med
    Verified postcode
    St Louis, United States
  • Memorial Sloan Kettering Bergen
    Verified postcode
    Montvale, United States
  • Memorial Sloan Kettering Cancer Center at Westchester
    Verified postcode
    Harrison, United States
  • Memorial Sloan Kettering Cancer Center
    Verified postcode
    New York, United States
  • Baylor University Medical Center
    Verified postcode
    Dallas, United States
  • Aarhus Universitetshospital Skejby
    Verified postcode
    Aarhus N, Denmark
  • Hopital Henri Mondor
    Verified postcode
    Créteil, France
  • Centre Henri Becquerel
    Verified postcode
    Rouen, France
  • Universitair Medisch Centrum Groningen
    Verified postcode
    Groningen, Netherlands

Common questions

What is DLBCL?

DLBCL stands for Diffuse Large B-Cell Lymphoma. It's a type of cancer that starts in white blood cells called lymphocytes, which are part of your immune system.

What is 'high-risk' DLBCL?

In this study, 'high-risk' DLBCL refers to a specific type of the disease identified through a special blood test called a 'circulating tumour DNA' test. This test helps doctors understand your individual disease better.

What is Glofitamab?

Glofitamab is a new drug being tested. It works by helping your own immune system fight the cancer cells. It's given through an injection or drip.

What is R-CHOP?

R-CHOP is a very common combination of chemotherapy drugs and other medicines used to treat many types of lymphoma, including DLBCL. It's a standard part of the treatment being studied here.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason, without needing to give an explanation. Your decision will not affect your future medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.