Ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humansInterventional

APTIVATE Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tuspetinib (HM43239) in Patients with Relapsed or Refractory Acute Myeloid Leukemia.

This study, called APTIVATE, is for adult patients in the UK who have Acute Myeloid Leukaemia (AML). This is a type of blood cancer where your body makes too many abnormal white blood cells. This study is specifically for those whose AML has either returned after treatment (relapsed) or hasn't responded to previous treatments (refractory). The main goal is to test a new medication called tuspetinib (HM43239). The researchers want to find out if this new medicine is safe for people to take, what side effects it might have, and how it acts in the body. This is an early-stage study, meaning it's one of the first times this medicine is being given to people, to understand its potential role in treating AML.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Aptose Biosciences Inc.

Enrolment target

103

Start

12 Jun 2023

Relapsed or Refractory Acute Myeloid Leukemia (AML)

What is this study about?

Imagine your body's blood-making factory, constantly producing new cells to keep you healthy. In Acute Myeloid Leukaemia (AML), this factory goes wrong, creating faulty white blood cells that don't do their job properly and crowd out healthy cells. For some people, AML can be very difficult to treat, especially if it comes back after treatment or doesn't get better with standard medicines. When this happens, doctors sometimes call it 'relapsed' or 'refractory' AML.

This study, called APTIVATE, is looking into a new medicine named tuspetinib (HM43239). The main idea is to see if this new medicine can help people with AML that has returned or hasn't responded to other treatments. Researchers want to understand if it's safe to use, what kind of effects it has on the body, and how the body handles the medicine.

Finding new and better ways to treat AML is really important for patients. By taking part in studies like APTIVATE, patients can help doctors learn more about diseases and develop new treatments for the future. This study is an important step in that journey, helping us understand if tuspetinib could one day be a useful option for AML patients.

Key takeaways

This study is for adults with AML that has either returned or not responded to previous treatments.
It's testing a new medicine called tuspetinib (HM43239) to see if it's safe and how it works.
Participants will receive the new medicine and have regular check-ups and tests.
Potential benefits include access to a new treatment, but there are also unknown risks.
Participation is voluntary, and you can leave the study at any time.
This is an early-stage study, helping doctors learn more about new AML treatments.

Who may be eligible?

This study is designed for adults aged 18 and over who have been diagnosed with a specific type of blood cancer called Acute Myeloid Leukaemia (AML). It's particularly for those where the cancer has either returned after previous treatment or hasn't responded to the treatment they've already had.

Before you can join, a medical team will carefully check your health to make sure the study is a good fit for you and that you meet all the necessary requirements for safety. This may include reviewing your medical history, recent test results, and overall health to ensure you can safely take part in the study and that the results will be meaningful.

Both men and women can take part in this study. The medical team will discuss all the specific criteria with you to confirm if you are 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.

Are you 18 years old or older?
Have you been diagnosed with Acute Myeloid Leukaemia (AML)?
Has your AML either come back after treatment (relapsed) or not responded to previous treatment (refractory)?
Are you able to attend regular hospital or clinic appointments?
Are you willing to undergo various tests like blood samples?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the new medicine, tuspetinib (HM43239). You'll have regular visits to the hospital or clinic so the study team can monitor your health closely, check how you're responding to the medicine, and look for any side effects. These visits will involve various tests, such as blood samples, to see how the medicine is working in your body and to track changes in your AML. You'll also have physical exams and discussions about how you're feeling.

The study will involve several cycles of treatment, and the total duration of your participation will depend on how you respond to the medicine and if you experience any side effects. After finishing the treatment part of the study, there will likely be follow-up visits to continue monitoring your health for a period. The study team will explain the exact schedule of visits, tests, and medication doses during the consent process.

Potential risks and benefits

Taking part in a clinical study can have potential benefits, such as gaining access to a new medicine before it's widely available, which might help your condition. However, there are also potential risks, as the new medicine's full effects and side effects are still being investigated. You might experience side effects that are currently unknown, or the medicine might not help your condition. The study team will explain all the known and potential risks in detail. It's important to remember that joining a study is always voluntary, and you have the right to withdraw at any time for any reason, without it affecting your usual medical care.

Locations (4)

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

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Unverified
Poland
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Unverified
Germany
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Unverified
Sweden
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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, which is the spongy tissue inside bones where blood cells are made. It causes your body to make too many abnormal white blood cells.

What does 'relapsed' or 'refractory' mean for AML?

'Relapsed' means the AML has come back after treatment. 'Refractory' means the AML didn't get better or respond to previous treatments.

What is tuspetinib (HM43239)?

Tuspetinib (HM43239) is the name of the new medicine being tested in this study. It's designed to potentially treat AML, and researchers are studying how safe and effective it is.

Are there any costs involved in joining the study?

No, you will not have to pay for the study medication or any study-related tests or appointments. These are covered by the study.

How long will I be in the study?

The total time you will spend in the study can vary. It depends on how you respond to the medicine and if you have any side effects. The study team will discuss this in detail.