Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

HOVON 146 ALL: Blinatumomab added to prephase and consolidation therapy in precursor B-acute lymphoblastic leukemia in adults. A phase II trial.

This study, called HOVON 146 ALL, is for adults with a type of blood cancer called B-cell acute lymphoblastic leukaemia. It's a Phase II trial, meaning it's exploring how well a new treatment approach works and if it's safe. Researchers are investigating if adding a drug called Blincyto to the usual pre-treatment and follow-up (consolidation) therapy can help more patients achieve a "minimal residual disease negative response." This means doctors are looking to see if very few, if any, cancer cells remain after treatment, which is a good sign for recovery. The study aims to understand how many patients reach this important milestone and also looks at other factors like side effects and how long patients stay well.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting

Enrolment target

Start

12 Nov 2024

Precursor B-acute lymphoblastic leukemia

What is this study about?

This research study is about finding better ways to treat a serious blood cancer called B-cell acute lymphoblastic leukaemia, or ALL, in adults. ALL affects the white blood cells in your body. In this study, doctors are looking at a drug called Blincyto. They want to see if adding Blincyto to the usual treatment steps for ALL can help more patients get rid of very small amounts of cancer cells that standard tests might miss. This is important because even tiny amounts of remaining cancer cells can sometimes lead to the cancer coming back.

The main goal of the study is to check how many patients achieve a "minimal residual disease negative response" after receiving the Blincyto treatment. This means that after a certain part of the treatment, doctors will use very sensitive tests to see if there are fewer than 1 in 10,000 cancer cells left in your body. If you reach this goal, it’s a positive sign for your long-term health. The study also looks at other things, such as how patients feel, how long they stay healthy, and any side effects.

By taking part in studies like this, researchers hope to improve existing treatments and develop new ones, ultimately leading to better outcomes and a higher quality of life for people with B-cell ALL. This particular study is in an earlier stage (Phase II), which means it's focusing on whether the new treatment approach shows promise and is safe enough to study further.

Key takeaways

This study explores a new treatment for adult B-cell acute lymphoblastic leukaemia.
It tests adding Blincyto to standard treatment to reduce tiny cancer cells.
The main goal is to see how many patients achieve a very low level of remaining cancer (MRD negative).
It's a Phase II trial, focusing on treatment effectiveness and safety.
Participation involves receiving Blincyto and having regular tests to monitor health and treatment response.

Who may be eligible?

To be considered for this study, you would need to be an adult, aged 18 years or older. The study is open to both men and women.

Typically, for studies like this, you would need to have been recently diagnosed with B-cell acute lymphoblastic leukaemia (ALL) and about to start or be in the early stages of your treatment journey. There would also be specific health checks, like your general fitness and how well your organs are working, to make sure it's safe for you to take part.

Your doctor will be able to check all the specific details to see if this study could be an option for you, based on your individual health and medical history.

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.

Are you 18 years old or older?
Have you been diagnosed with B-cell acute lymphoblastic leukaemia (ALL)?
Are you willing to receive the study drug Blincyto in addition to your standard treatment?
Are you able to attend regular hospital appointments for tests and monitoring?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive the study drug, Blincyto, as an infusion (given through a drip into your vein), in addition to your standard leukaemia treatments. The Blincyto would be given during specific periods of your treatment plan, both before your main treatment and during the 'consolidation' phase, which is treatment designed to keep the cancer away after it's in remission.

You would have regular visits to the hospital for various assessments. These would include blood tests, and potentially bone marrow tests, to check for cancer cells and monitor your general health. Doctors would specifically be tracking levels of "minimal residual disease" to see how well the treatment is working. These tests help the doctors understand the impact of the Blincyto.

Throughout the study, side effects would be carefully monitored. The total length of your participation would depend on your course of treatment and the follow-up schedule, which could involve observations for several years to track your long-term health and any cancer recurrence.

Potential risks and benefits

Taking part in a study like this offers the potential benefit of receiving a new treatment that might improve your chances of getting rid of your cancer more effectively. However, there are also potential risks, as Blincyto, like any medication, can have side effects. These could range from mild to more serious, and the study team will monitor you closely for any unwanted effects. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Belgium
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Unverified
Netherlands

Common questions

What is B-cell acute lymphoblastic leukaemia (ALL)?

It's a type of blood cancer where the body makes too many immature white blood cells, called lymphoblasts. These cells don't work properly and can stop your body from making healthy blood cells.

What is Blincyto?

Blincyto is a special type of drug that helps your body's immune system fight cancer cells. It works by bringing your immune cells closer to the leukaemia cells so they can attack them.

What does 'minimal residual disease' mean?

Minimal residual disease (MRD) refers to a very small number of cancer cells that might remain in your body after treatment, even when you feel well and standard tests show no sign of cancer. Finding and treating these cells can be important.

What is a 'Phase II trial'?

A Phase II trial means the study is looking more closely at how well a new treatment works for a specific condition and if it's safe. It's usually done after a Phase I trial has shown the treatment is safe to use in humans.

Will I still get my usual treatment if I join this study?

Yes, if you join this study, Blincyto would be added to parts of your standard treatment for B-cell ALL, not replace it entirely.