Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2 Study of Cusatuzumab Plus Azacitidine in Patients With Newly Diagnosed Acute Myeloid Leukemia who are not Candidates for Intensive Chemotherapy

This clinical trial is designed for adults with a type of blood cancer called acute myeloid leukaemia (AML). This study is for people who have been newly diagnosed with AML and whose doctors believe that they are not suitable for very intensive chemotherapy. Researchers are testing a combination of two drugs, cusatuzumab and azacitidine. The main aim is to find out how many patients respond well to this treatment, meaning their cancer goes into remission (a complete response). The study will also look at other important things, like how long the treatment keeps the cancer under control, whether patients need fewer blood transfusions, and if the treatment causes any side effects. By understanding these aspects, doctors hope to find better and gentler treatment options for AML patients.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

OncoVerity Inc.

Enrolment target

Start

11 Jul 2024

Acute Myeloid Leukemia

What is this study about?

Acute myeloid leukaemia (AML) is a type of cancer that starts in the blood-forming cells of the bone marrow. It usually gets worse quickly if not treated. For many people, one of the main treatments is strong chemotherapy, but this isn't always an option for everyone, especially if they have other health problems or are older. This study is for those newly diagnosed AML patients who aren't able to have this intensive chemotherapy.

This trial is looking at a new way to treat AML using two different drugs together: cusatuzumab and azacitidine. Azacitidine is a treatment that doctors already use for AML. Cusatuzumab is a newer drug that is thought to work by targeting specific cells that help the cancer grow. By combining these two drugs, researchers hope to see if they can get a better response against the leukaemia.

The main goal of this study is to see how many people achieve a 'complete response'. A complete response means there are no signs of leukaemia in the bone marrow and blood, and normal blood counts return. The study will also carefully check for side effects, how long the treatment works, and whether patients need fewer blood transfusions. This research is important because it could lead to new, gentler treatment options for people with AML who can't have the usual strong chemotherapy.

Key takeaways

This study is testing a new drug combination for newly diagnosed AML.
It's for people who can't have strong chemotherapy.
The main aim is to see how many people's leukaemia goes into remission.
The study will also track side effects and other health improvements.
Participation involves regular clinic visits and tests.
You can stop participating at any time.

Who may be eligible?

To be considered for this study, you must be at least 18 years old. Both men and women can take part. You must have been recently diagnosed with a type of blood cancer called Acute Myeloid Leukaemia (AML).

Crucially, your doctors must also believe that strong, intensive chemotherapy is not the right treatment option for you. This could be due to your age, other health conditions you have, or how well your body might handle such strong treatment.

There will be other detailed medical checks to make sure the study is a safe and suitable option for you. These will be explained by the study team.

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 newly diagnosed with Acute Myeloid Leukaemia (AML)?
Has your doctor told you that intensive chemotherapy is not suitable for you?
Are you able to attend regular clinic appointments for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new combination treatment consisting of cusatuzumab and azacitidine. These drugs are usually given through injections or drips. The study team will carefully explain the schedule for these treatments, and how often you will need to come to the clinic for your medications and check-ups.

You would have regular appointments where the study team will monitor your health closely. This will involve blood tests to check your blood cell counts, look for any signs of the leukaemia, and see how your body is responding to the treatment. You might also have bone marrow tests to get a clearer picture of the leukaemia. The team will also monitor you for any side effects and ask you about how you are feeling.

The total length of your participation in the study will depend on how you respond to the treatment and other factors, and the study team will discuss this in detail with you. There will also be follow-up appointments after your treatment finishes to continue monitoring your health.

Potential risks and benefits

Taking part in a clinical trial offers the potential benefit of accessing new and promising treatments not yet widely available. While there is hope that this new combination treatment could be more effective or have fewer side effects than other options, there's no guarantee it will work for everyone, and it might not work better than existing treatments. Like all medicines, the study drugs can have side effects, which doctors will carefully monitor. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Spain

Common questions

What is Acute Myeloid Leukaemia (AML)?

AML is a type of cancer that affects the blood and bone marrow, where new blood cells are made. It causes too many faulty white blood cells to be produced.

Why is this study for people who can't have chemotherapy?

Strong chemotherapy can be very difficult for the body to cope with. This study is for people who, for various reasons, might not be strong enough for intensive chemotherapy, offering them a different treatment option.

What is a 'complete response'?

A complete response means that tests show no signs of the leukaemia in your body, and your blood counts have returned to normal.

Will I have to pay for the treatment?

No, all treatment and study-related tests provided as part of the clinical trial would be free of charge.

What if the treatment doesn't work for me?

The study team will continuously monitor your progress, and if the treatment isn't working as expected, they will discuss other available treatment options with you and your doctor.