All studies
RecruitingPHASE3INTERVENTIONAL

AZD0486 1L Therapy for Elderly or Unfit Participants With LBCL

This study, called AZD0486 1L Therapy, is for people aged 65 and above who have been newly diagnosed with Large B-cell Lymphoma (LBCL) and may not be strong enough for the usual intensive chemotherapy. Doctors want to see if adding an investigational drug, AZD0486, to a lighter version of standard chemotherapy (R-mini-CHOP) works better and is safe, compared to giving only the lighter standard chemotherapy. The study will look at how well the new combination shrinks the cancer and how patients tolerate it. It's important to find gentler but effective treatments for older or frailer individuals with this type of cancer.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
AstraZeneca
Enrolment target
420
Start
11 Nov 2025
Estimated completion
28 Jul 2033

What is this study about?

This study is for people who have been recently diagnosed with a type of blood cancer called Large B-cell Lymphoma (LBCL). LBCL is a fast-growing cancer that affects white blood cells called B-cells. For older patients or those who aren't strong enough for standard, more intense treatments, doctors are looking for kinder options that are still effective.

The study aims to see if a new treatment approach is better than the current standard for these patients. One group will receive two cycles of a milder chemotherapy called R-mini-CHOP, followed by a new experimental drug named AZD0486. The other group will receive six cycles of R-mini-CHOP on its own. By comparing these two groups, researchers hope to understand if adding AZD0486 improves treatment outcomes and is well-tolerated.

This kind of research is important because it helps develop new and potentially more suitable treatments for specific groups of patients, ensuring they receive care that is both effective against their cancer and manageable for their overall health.

Key takeaways

  • This study is for newly diagnosed Large B-cell Lymphoma in older or less-fit patients.
  • It tests a new drug (AZD0486) combined with a milder chemotherapy (R-mini-CHOP).
  • The goal is to find safer, more effective treatments for this patient group.
  • Participation involves regular treatments, tests, and monitoring.
  • You will be randomly assigned to one of two treatment groups.
  • You can withdraw from the study at any time.

Who may be eligible?

This study is looking for people who are 80 years or older, or between 65 and 79 years old and considered generally 'unfit' by their doctor. You must have been newly diagnosed with a specific type of Large B-cell Lymphoma, and your cancer needs to be visible on scans and at a certain stage.

There are also some health requirements. For example, your body's main organs (like bone marrow, liver, kidneys, and heart) need to be working well. Overall, your doctor will assess if participating in the study is safe and appropriate for you.

However, you cannot join if you have certain other medical conditions, like a history of the cancer spreading to the brain, specific other types of lymphoma, uncontrolled infections, or major heart problems. You also cannot have received previous treatment for your lymphoma, or be on certain long-term medications that suppress your immune system, with some exceptions.

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 80 years or older, or between 65-79 and considered generally 'unfit' by your doctor?
  2. Have you been newly diagnosed with Large B-cell Lymphoma, not previously treated for it?
  3. Do you have a general good level of health in your main organs (like heart, liver, kidneys)?
  4. Do you NOT have certain other serious medical conditions, such as major heart problems, or the lymphoma in your brain?
  5. Are you able to visit the clinic regularly for treatments and check-ups?
Answer every question to see your result.

What does participation involve?

If you join this study, you'll be assigned to one of two treatment groups, which is decided randomly, like flipping a coin. You will receive either the combined treatment (R-mini-CHOP for two cycles followed by AZD0486) or R-mini-CHOP for six cycles. This will involve regular visits to the clinic for your treatments, which are usually given through a drip (intravenous infusion).

Throughout the study, you'll have regular medical check-ups, blood tests, and scans to monitor your health, how the treatment is working, and to check for any side effects. These assessments are crucial for the researchers to understand the safety and effectiveness of the treatments. The total duration of your active treatment will vary depending on which group you are in, and there will be follow-up appointments after your treatment finishes to see how you are doing long-term.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as access to new, investigational treatments that aren't yet widely available, and close medical monitoring. However, there are also potential risks involved. The treatments may cause side effects, some of which could be serious or unexpected. Researchers will carefully explain all known risks before you decide to participate. Your safety and well-being are paramount, and you have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (64)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Research Site
    Verified postcode
    Melbourne, Australia· Recruiting
  • Research Site
    Verified postcode
    Nedlands, Australia· Not yet recruiting
  • Research Site
    Verified postcode
    Waratah, Australia· Not yet recruiting
  • Research Site
    Verified postcode
    Antwerp, Belgium· Withdrawn
  • Research Site
    Verified postcode
    Brussels, Belgium· Suspended
  • Research Site
    Verified postcode
    Ghent, Belgium· Recruiting
  • Research Site
    Verified postcode
    Leuven, Belgium· Recruiting
  • Research Site
    Verified postcode
    Roeselare, Belgium· Suspended
  • Research Site
    Verified postcode
    Yvoir, Belgium· Recruiting
  • Research Site
    Verified postcode
    Porto Alegre, Brazil· Recruiting
  • Research Site
    Verified postcode
    São Paulo, Brazil· Recruiting
  • Research Site
    Verified postcode
    Calgary, Canada· Recruiting

Common questions

What is Large B-cell Lymphoma?

It's a fast-growing cancer of white blood cells called B-cells, which are part of your immune system. It can appear in lymph nodes or other parts of the body.

What does 'unfit' mean in this context?

It means a doctor has assessed that you might not be strong enough or healthy enough for the usual intensive chemotherapy treatments, often due to age or other health conditions.

What is R-mini-CHOP?

It's a less intensive version of a standard chemotherapy treatment (R-CHOP) for lymphoma, designed to be gentler for patients who might not tolerate the full-strength version.

Will I know which treatment I'm getting?

The study is designed so that you will be randomly assigned to one of the treatment groups, like drawing lots. Your study doctor will explain which specific treatment you will receive as part of the study.

Can I leave the study at any time?

Yes, absolutely. Participating is always your choice, and you can withdraw from the study at any point, for any reason, without it affecting your medical care.

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 "AZD0486 1L Therapy for Elderly or Unfit Participants With LB…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

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