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RecruitingPHASE3INTERVENTIONAL

Surovatamig as Consolidation Therapy in Participants With Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated Immunoglobulin Heavy Chain Variable (IGHV)

This important study is looking into a new treatment called Surovatamig for adults living with specific types of chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL). These types are identified by a feature called 'unmutated IGHV'. The main goal is to find out if Surovatamig, given as an injection after standard initial treatment, is effective and safe. Researchers want to see if it can help stop the cancer from coming back or getting worse. This is a Phase 3 study, meaning it's a larger trial comparing Surovatamig to just observing patients, to understand its full potential in managing these conditions.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
AstraZeneca
Enrolment target
420
Start
05 May 2026
Estimated completion
05 Apr 2032

What is this study about?

This study is about a new medicine called Surovatamig. It's designed for people who have chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL). These are cancers that affect certain white blood cells. Importantly, this study is for those whose cancer has a specific genetic feature called 'unmutated IGHV'. This feature helps doctors understand how the cancer might behave and respond to treatments.

The main idea behind this study is to see if Surovatamig can help after you've already had your first course of standard treatment. Doctors call this 'consolidation therapy'. Think of it like making a building stronger after the main construction is done. The aim is to see if Surovatamig can help keep the cancer from growing or coming back, making your initial treatment work better for longer.

This is a 'Phase 3' study, which means it's a larger, more advanced stage of testing. Researchers want to compare Surovatamig with just careful observation to understand its benefits and any potential side effects. Half the people in the main part of the study will receive Surovatamig, and the other half will be carefully monitored without it. This comparison helps doctors learn if Surovatamig is truly helpful.

Key takeaways

  • This study is for people with specific types of chronic leukaemia or lymphoma (CLL/SLL with unmutated IGHV).
  • It tests a new medicine called Surovatamig given after initial treatment to prevent cancer progression.
  • Participation involves either receiving Surovatamig injections or being closely observed.
  • It's a Phase 3 study, meaning it’s a larger trial aiming to confirm the effectiveness and safety.
  • Your health will be monitored closely with regular hospital visits, blood tests, and scans.

Who may be eligible?

This study is for adults aged 18 and over who have been diagnosed with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL), specifically with the 'unmutated IGHV' feature. You must have already completed your first round of standard treatment and your doctors need to have been able to assess how well that treatment worked.

There are also some general health checks. You need to be generally well enough to take part and have good liver, kidney, blood, and heart health. Women who could become pregnant and men who are sexually active with women who could become pregnant will need to use effective contraception.

However, you cannot join if your cancer has changed into a more aggressive type, or if your cancer has affected your brain or spinal cord. Also, if you have certain serious infections (like uncontrolled hepatitis B or C, or HIV), major heart problems, or need ongoing strong medicines to suppress your immune system, you wouldn't be able to take part. People with a history of serious blood disorders like HLH or certain other cancers are also not suitable.

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 Chronic Lymphocytic Leukaemia (CLL) or Small Lymphocytic Lymphoma (SLL)?
  2. Has my doctor confirmed my cancer has the 'unmutated IGHV' feature?
  3. Have I completed my first course of standard treatment for my cancer?
  4. Am I generally in good health otherwise, with good organ function (heart, liver, kidneys, blood cells)?
  5. Am I aged 18 or older?
  6. Do I have any other serious health conditions like uncontrolled infections, major heart problems, or other active cancers?
Answer every question to see your result.

What does participation involve?

If you join this study, it will involve two main parts. First, a small group of participants will help doctors figure out the best dose of Surovatamig. This might mean starting at a slightly lower dose and then adjusting it. Once the optimal dose is found, the main part of the study begins. Here, you would be randomly placed into one of two groups: one group will receive Surovatamig as an injection under the skin, and the other group will be carefully monitored by doctors without receiving Surovatamig.

Taking part will involve regular visits to the hospital for check-ups, blood tests, and scans to monitor your health and how the treatment is working (or how your condition is progressing if you're in the observation group). The exact schedule and total duration of your participation will be explained in detail by the study team, but it will involve ongoing assessments as part of this longer-term study.

Potential risks and benefits

Like all medical studies, there are potential benefits and risks. The potential benefit of taking Surovatamig could be that it helps to keep your leukaemia or lymphoma under control for longer after your initial treatment. However, it's a new medicine, so there might be side effects that are not fully known yet. These could range from mild discomfort at the injection site to more serious reactions. The study team will monitor you closely for any side effects. It’s important to remember that you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (30)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Research Site
    Verified postcode
    Adelaide, Australia· Not yet recruiting
  • Research Site
    Verified postcode
    Fitzroy, Australia· Not yet recruiting
  • Research Site
    Verified postcode
    Heidelberg, Australia· Not yet recruiting
  • Research Site
    Verified postcode
    Nedlands, Australia· Recruiting
  • Research Site
    Verified postcode
    Perth, Australia· Not yet recruiting
  • Research Site
    Verified postcode
    Rockingham, Australia· Not yet recruiting
  • Research Site
    Verified postcode
    Calgary, Canada· Not yet recruiting
  • Research Site
    Verified postcode
    Vancouver, Canada· Not yet recruiting
  • Research Site
    Verified postcode
    Halifax, Canada· Not yet recruiting
  • Research Site
    Verified postcode
    Hamilton, Canada· Not yet recruiting
  • Research Site
    Verified postcode
    Toronto, Canada· Recruiting
  • Research Site
    Verified postcode
    Montreal, Canada· Not yet recruiting

Common questions

What is 'unmutated IGHV'?

This is a specific genetic feature of your cancer cells that doctors can test for. It helps them understand more about your type of leukaemia or lymphoma.

What does 'consolidation therapy' mean?

It means giving an extra treatment after your first main round of treatment. The goal is to strengthen the good effects of the initial treatment and reduce the chance of the cancer coming back.

How will I receive Surovatamig if I get it?

Surovatamig is given as an injection under the skin, similar to some other common medical injections.

Why is there an 'observation' group?

Having an observation group allows researchers to compare the effects of Surovatamig directly against what happens when patients don't receive this specific extra treatment, helping to prove if it's truly beneficial.

Can I still get my standard care if I join?

Yes, this study is testing Surovatamig *after* you've received your standard initial treatment. Your regular medical care will continue throughout the study.

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 "Surovatamig as Consolidation Therapy in Participants With Ch…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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