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RecruitingPHASE2INTERVENTIONAL

A Study to Evaluate the Optimization of the Cytokine Release Syndrome Profile for Glofitamab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed/Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma

This research study is for people with a type of blood cancer called B-cell non-Hodgkin's lymphoma, specifically if it has come back or hasn't responded to previous treatments. It's looking at a new way to give a drug called glofitamab, in combination with two other medicines: gemcitabine and oxaliplatin. The main aim is to make sure this combined treatment is as safe as possible by carefully managing a potential side effect called cytokine release syndrome (CRS). Researchers are testing a special way of giving steroid medication before treatment and a careful monitoring plan. The hope is that by doing this, people might be able to receive this treatment without needing to stay in hospital, making it more convenient and potentially accessible.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
Hoffmann-La Roche
Enrolment target
100
Start
05 Mar 2025
Estimated completion
30 Mar 2029

What is this study about?

This study is investigating a new treatment approach for people living with a type of cancer called B-cell non-Hodgkin's lymphoma. This is a cancer that starts in certain white blood cells and can be quite aggressive. The study is specifically for people whose cancer has either returned after previous treatments (relapsed) or hasn't responded well to earlier treatments (refractory).

The main combination of drugs being studied here includes glofitamab, gemcitabine, and oxaliplatin. Glofitamab is a newer type of drug designed to help your immune system fight cancer cells. It works by bringing your body's immune cells closer to the cancer cells to attack them. Gemcitabine and oxaliplatin are more traditional chemotherapy drugs that work by killing fast-growing cancer cells.

One common side effect with some newer cancer treatments is called cytokine release syndrome (CRS), which is when the immune system reacts very strongly, potentially causing fever, chills, and other symptoms. This study is focused on finding the best way to prevent or manage CRS when using glofitamab with these other drugs. They are testing a specific plan for giving steroid medication before treatment and a detailed schedule for checking on patients. The ultimate goal is to make this treatment safer and to allow people to receive it without needing to be admitted to the hospital, aiming for treatment in an outpatient setting.

Key takeaways

  • This study is for aggressive B-cell non-Hodgkin's lymphoma that has returned or not responded to prior treatments.
  • It combines a newer immune-boosting drug (glofitamab) with two chemotherapy drugs (gemcitabine and oxaliplatin).
  • A main goal is to safely manage a side effect called cytokine release syndrome (CRS) using special steroid treatment and monitoring.
  • The study hopes to allow treatment in an outpatient setting, meaning fewer hospital stays.
  • Participation requires specific health conditions and previous treatment history.
  • All treatment decisions should be made in discussion with your doctor.

Who may be eligible?

To be considered for this study, you would generally need to have a confirmed diagnosis of certain types of aggressive B-cell non-Hodgkin's lymphoma that has returned or not responded to previous treatments. You must have had at least one prior treatment for your lymphoma. If you've only had one previous treatment, you usually wouldn't be able to join if you're a good candidate for a stem cell transplant, as that might be a more standard option for you.

Your general health also needs to be good enough to participate. This means your doctor will check your overall physical condition, and you need to have certain levels of blood cell counts and kidney function. The cancer also needs to be measurable on scans so doctors can track how it responds to the treatment. Crucially, your doctor needs to believe that you would be able to handle the initial doses of treatment in an outpatient setting, meaning you wouldn't need to stay in the hospital.

There are also some reasons why you might not be able to join. For instance, if you've previously been part of certain other specific research studies, or if you've already had glofitamab or similar drugs. Certain other medical conditions or reactions to specific medications (like obinutuzumab, gemcitabine, oxaliplatin, or tocilizumab) would also mean you couldn't participate. You also can't have had gemcitabine or oxaliplatin before this study, or have certain types of nerve damage.

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. Do I have a confirmed diagnosis of aggressive B-cell non-Hodgkin's lymphoma?
  2. Has my lymphoma come back or not responded well to previous treatments?
  3. Have I had at least one prior treatment for my lymphoma?
  4. Am I generally well enough, and does my doctor think I can handle the treatment mostly as an outpatient?
  5. Have I NOT had glofitamab or certain similar drugs before?
  6. Have I NOT had gemcitabine or oxaliplatin before?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive several different medications. These include obinutuzumab, glofitamab, gemcitabine, and oxaliplatin. Before starting the main treatment, you'll likely receive steroid medication to help prevent side effects. The study involves regular visits to the clinic for your treatments and to have your health monitored closely. The researchers will be paying special attention to a side effect called cytokine release syndrome (CRS), particularly during the initial doses of glofitamab, to ensure your safety. They will look at your blood tests and other assessments often. The aim is to deliver the early stages of treatment in an outpatient setting, meaning you'd go home after your treatment sessions rather than staying in the hospital. The total duration of your participation in the study would be determined by your response to treatment and your doctor's assessment, followed by a period of follow-up to track your long-term health.

Potential risks and benefits

Taking part in any clinical trial involves both potential benefits and potential risks. You might benefit from receiving a new combination of treatments for your cancer that isn't widely available yet, which could help if your cancer hasn't responded to previous therapies. However, like all medications, the drugs used in this study can have side effects, including a strong immune system reaction called cytokine release syndrome (CRS), although the study is designed to manage this carefully. There could also be other side effects from the chemotherapy drugs or the other medications. It's important to remember that your participation is voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (53)

  • Alaska Oncology & Hematology, LLC
    Verified postcode
    Anchorage, United States· Recruiting
  • Community Cancer Institute (CCI)
    Verified postcode
    Clovis, United States· Recruiting
  • Providence Medical Foundation
    Verified postcode
    Fullerton, United States· Recruiting
  • Los Angeles Cancer Network
    Verified postcode
    Glendale, United States· Recruiting
  • Valkyrie Clinical Trials
    Verified postcode
    Los Angeles, United States· Recruiting
  • Valkyrie Clinical Trials
    Verified postcode
    Panorama City, United States· Recruiting
  • Zuckerberg San Francisco General Hospital
    Verified postcode
    San Francisco, United States· Recruiting
  • The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente
    Verified postcode
    Torrance, United States· Recruiting
  • Rocky Mountain Cancer Centers, LLP
    Verified postcode
    Aurora, United States· Recruiting
  • North Florida/ South Georgia VA Medical Center
    Verified postcode
    Gainesville, United States· Recruiting
  • Mount Sinai Comprehensive Cancer Center
    Verified postcode
    Miami, United States· Recruiting
  • Orlando Health Cancer Institute
    Verified postcode
    Orlando, United States· Recruiting

Common questions

What is B-cell non-Hodgkin's lymphoma?

It's a type of cancer that starts in white blood cells called lymphocytes, which are part of your immune system. 'B-cell' refers to the specific type of lymphocyte involved.

What is 'relapsed/refractory' cancer?

Relapsed means the cancer has come back after treatment. Refractory means the cancer didn't respond to previous treatments or got worse within 6 months of finishing treatment.

What is cytokine release syndrome (CRS)?

CRS is a potential side effect of some newer cancer treatments, where your immune system reacts very strongly, causing symptoms like fever, chills, and flu-like feelings. This study aims to manage it carefully.

Will I have to stay in the hospital?

The study aims to allow you to receive the early, crucial doses of treatment as an outpatient, meaning you go home after your treatment sessions. This is a key goal of this research.

Are the treatments in this study new?

Glofitamab is a newer type of drug that helps your immune system fight cancer. Gemcitabine and oxaliplatin are established chemotherapy drugs. This study is testing this specific combination and a special way of giving them.

How to find out more

Reference Study ID Number: GO45434 https://forpatients.roche.com/

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

Interested in taking part?

Register your interest

Share your details and the research team for "A Study to Evaluate the Optimization of the Cytokine Release…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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