Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A trial to learn if AZD9829 is safe and works alone and in combination with other treatments for participants with certain blood cancers.

Doctors are running a new study to learn about a medicine called AZD9829. This medicine is being tested for people with specific blood cancers that have come back or haven't responded to previous treatments. These include acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS). The main goal is to find out if AZD9829 is safe for people to take and to see how well it works. Researchers will look at using it by itself and also combined with other existing treatments. This is an early-stage study, meaning it's the first time this medicine is being given to people, so we are learning a lot about it.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Astrazeneca AB

Enrolment target

Start

07 May 2024

CD123-Positive Hematological Malignancies: Module 1 focuses on R/R Acute Myeloid Leukemia and R/R Myelodysplastic Syndrome.

What is this study about?

Imagine your body's blood cells, which are made in your bone marrow, aren't forming correctly. This can happen in conditions like acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS). In these conditions, blood cells don't mature properly or grow out of control, which can cause serious health problems. For many people, existing treatments work well, but for some, the cancer might come back (recur) or not respond to treatment at all. This is when new medicines are needed.

This study is looking at a new medicine called AZD9829. Scientists have designed this medicine to target a specific protein called CD123, which is often found on the surface of cancer cells in these types of blood cancers. By targeting CD123, the hope is that AZD9829 could help get rid of these cancer cells. This is an early-stage study, often called a Phase 1 study, which means it's one of the first times this medicine is being given to people.

The main aim of this study is to answer two very important questions: First, is AZD9829 safe for people to take? And second, how well does it work, both on its own and when given together with other treatments? The information we gather will help doctors understand more about this new medicine and whether it could be a helpful option for people dealing with these challenging blood cancers in the future.

Key takeaways

This study is testing a new medicine called AZD9829 for specific blood cancers.
It aims to find out if the medicine is safe and how well it works.
The study includes people with certain types of leukaemia and myelodysplastic syndrome (MDS).
It is an early-stage (Phase 1) study, meaning it's one of the first times people are taking this medicine.
Participation involves regular hospital visits for check-ups and tests.
There are potential benefits and risks, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old – there's no upper age limit. Doctors are looking for both men and women to take part.

You would be considered for this study if you have been diagnosed with certain types of blood cancers, specifically acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS). Importantly, your cancer must have either returned after previous treatment or not responded well to treatments you've already had. The cancer cells also need to have a specific marker called CD123.

There might be other health conditions or medications that would mean you couldn't join the study, as well as specific test results. These details will be discussed with you by the study doctor to make sure it's safe for you to participate.

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?
Do you have a diagnosis of acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS)?
Has your AML or MDS either come back or not responded to previous treatments?
Has your doctor told you that your cancer cells have a marker called CD123?
Are you able to attend regular hospital appointments for check-ups and tests?

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 medicine, AZD9829, which is likely given as a tablet or injection. The study will involve regular visits to the clinic or hospital. These visits will allow the study team to carry out various assessments. These might include blood tests (to check your general health, how the medicine is working, and for any side effects), urine tests, physical check-ups, and scans.

At these visits, the doctors and nurses will closely monitor your health and how you're reacting to the medicine. They will also ask you about any symptoms or side effects you might be experiencing. The amount of medicine you receive may be carefully adjusted by the doctors as part of the study design. You will be followed up for a period after you stop taking the study medicine. The total duration of your participation in the study, including treatment and follow-up, will be explained in detail by the study team, but it could last several months or longer.

Potential risks and benefits

Taking part in any medical study has both potential benefits and risks. A potential benefit of this study is that you might receive access to a new medicine that could help your condition, especially if other treatments haven't worked. You would also be closely monitored by a healthcare team. However, because this is a new medicine, there might be side effects or risks that are not fully known yet. You might experience side effects from the study medicine, or it might not help your cancer. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

—
Unverified
Spain
—
Unverified
Italy
—
Unverified
Germany

Common questions

What is AZD9829?

AZD9829 is a new medicine being tested for certain blood cancers. This study will help us understand if it's safe and effective.

What are blood cancers like AML and MDS?

These are conditions where the body doesn't make healthy blood cells properly. In AML, unhealthy cells multiply quickly, and in MDS, blood cells don't fully mature.

Is this medicine available to everyone?

No, AZD9829 is still in the trial stage and is not available outside of this study. It needs to be proven safe and effective first.

Will I definitely get the new medicine?

Yes, if you join this study, you will receive AZD9829, either on its own or with other treatments.

What if I change my mind during the study?

You are free to leave the study at any time, for any reason, without it affecting your medical care.