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RecruitingPHASE3INTERVENTIONAL

A Study of Surovatamig (AZD0486) Plus Rituximab in Previously Untreated Follicular Lymphoma Patients

This research study is for people recently diagnosed with follicular lymphoma who haven't had treatment yet. It's investigating a new medication called Surovatamig, given alongside an existing drug called rituximab. The main goal is to see if this new combination is more effective and safer than the current standard treatments for follicular lymphoma. The study will compare patients receiving Surovatamig plus rituximab with those receiving one of three common treatments. This is a large, worldwide study, and participants will be randomly assigned to different treatment groups. The information gathered will help doctors understand the best ways to treat follicular lymphoma in the future.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
AstraZeneca
Enrolment target
1,018
Start
07 Aug 2024
Estimated completion
26 Nov 2031

What is this study about?

This study is designed for individuals recently diagnosed with a type of cancer called follicular lymphoma, who have not yet started any treatment for it. The main purpose is to explore a new drug, Surovatamig, when given with another common lymphoma treatment called rituximab. Doctors want to find out if this new combination is better at treating the lymphoma and just as safe as the treatments currently used.

To do this, the study compares the new Surovatamig and rituximab combination with three standard chemotherapy and immunotherapy treatments (R-CHOP, R-CVP, or BR), which are often given with rituximab maintenance. Participants in this study will be randomly assigned to receive either the new combination or one of the standard treatments chosen by their doctor. There will also be a small initial phase to determine the safest and most effective dose of Surovatamig.

Finding more effective and safer treatments for follicular lymphoma is important for patients. This study will gather crucial information on how well the new combination works, any side effects it might have, and how it compares to established treatments. This information will help doctors make informed decisions about future treatment options for people with follicular lymphoma.

Key takeaways

  • New study for previously untreated follicular lymphoma.
  • Compares Surovatamig + rituximab with standard treatments.
  • Aims to find more effective and safer treatment options.
  • Participation involves regular checks and monitoring.
  • You can withdraw from the study at any time.

Who may be eligible?

To join this study, you generally need to be at least 18 years old and have a confirmed diagnosis of classic follicular lymphoma that hasn't been treated before. Your general health should be good enough for you to take part, and your lymphoma needs to be at a stage where treatment is recommended. Doctors will check your organ function (like your liver, kidneys, and heart) to make sure you're healthy enough.

There are also certain reasons why someone might not be able to join. For example, if your follicular lymphoma is a specific rare type, or if doctors suspect it has changed into a more aggressive lymphoma, you wouldn't be eligible. You also can't have certain other medical conditions, a history of lymphoma in the brain or spine, or allergies to the study medications. If you have any serious infections, you also wouldn't be able to participate straight away.

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 been diagnosed with classic follicular lymphoma?
  3. Have you never received treatment for your lymphoma before?
  4. Are you generally in good health?
  5. Do you have no other serious medical conditions that would prevent participation?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first go through a screening process to see if the study is right for you. This will involve detailed health checks and tests. Once eligible, you'll be randomly assigned to one of several treatment groups. This means you might receive the new drug combination or one of the standard treatments. Your doctors will carefully monitor your health throughout the study, which will involve regular visits, blood tests, scans, and other assessments to track your progress and check for any side effects.

Participation could last for a significant period, involving treatment cycles and then follow-up appointments. The exact duration will depend on your assigned treatment and how you respond. The study team will provide you with a clear schedule of visits and what to expect at each stage. You will also receive the study medication, with clear instructions on how and when to take it.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. You might gain access to a new treatment before it's widely available, which could be more effective. However, there's no guarantee the new treatment will work for everyone, and it might have side effects that are different from or worse than standard treatments. The study team will carefully monitor you for any side effects and support you throughout. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (193)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Research Site
    Verified postcode
    Huntsville, United States· Not yet recruiting
  • Research Site
    Verified postcode
    Anchorage, United States· Not yet recruiting
  • Research Site
    Verified postcode
    Phoenix, United States· Not yet recruiting
  • Research Site
    Verified postcode
    Clovis, United States· Not yet recruiting
  • Research Site
    Verified postcode
    Los Alamitos, United States· Not yet recruiting
  • Research Site
    Verified postcode
    San Diego, United States· Not yet recruiting
  • Research Site
    Verified postcode
    Santa Monica, United States· Not yet recruiting
  • Research Site
    Verified postcode
    Aurora, United States· Withdrawn
  • Research Site
    Verified postcode
    New Haven, United States· Not yet recruiting
  • Research Site
    Verified postcode
    Newark, United States· Not yet recruiting
  • Research Site
    Verified postcode
    Jacksonville, United States· Not yet recruiting
  • Research Site
    Verified postcode
    Atlanta, United States· Not yet recruiting

Common questions

What is follicular lymphoma?

Follicular lymphoma is a slow-growing type of cancer that affects particular white blood cells, called lymphocytes, in the lymphatic system.

What does 'untreated' mean in this study?

It means you have never received any medication or therapy specifically for your follicular lymphoma before starting this study.

What is Surovatamig (AZD0486)?

Surovatamig is a new investigational drug being tested to see how it works against follicular lymphoma when combined with rituximab.

Will I know which treatment I'm getting?

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

How long will I be in the study?

The study involves initial treatment cycles followed by regular follow-up appointments. The total duration will vary depending on your treatment and how you respond, but the study team can give you a more specific estimate.

How to find out more

AstraZeneca Clinical Study Information Center

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 of Surovatamig (AZD0486) Plus Rituximab in Previousl…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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