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Active not recruitingPHASE1, PHASE2INTERVENTIONAL

Study of AZD9829 in CD123+ Hematological Malignancies

This research study is investigating a new medication, AZD9829, for adults in the UK who have specific types of blood cancers, known as hematological malignancies. These cancers must have a particular marker called CD123. The study is for people who have already tried other treatments that are no longer working or are not suitable. It is split into two phases: the first phase will look at finding the right dose and checking for side effects, while the second phase will focus on how well the treatment works. Participants will receive AZD9829 either on its own or alongside other treatments. The main goal is to find out if AZD9829 is a safe and helpful new option for these types of blood cancers.

At a glance

Status
Active not recruiting
Phase
PHASE1, PHASE2
Sponsor
AstraZeneca
Enrolment target
56
Start
31 Jan 2024
Estimated completion
23 Mar 2026

What is this study about?

This study is looking into a new medication called AZD9829. It's designed for people in the UK who have certain types of blood cancers, which doctors call 'hematological malignancies'. These are cancers that affect the blood, bone marrow, and lymph nodes. What's special about the cancers in this study is that they all have a specific marker, like a flag, on their cells called CD123.

Doctors are interested in AZD9829 because it's designed to target these CD123 markers. The study is for adults whose cancer has either come back or hasn't responded to previous treatments, and who don't have other standard treatment options left. The researchers want to carefully test AZD9829 to see if it's safe and if it can help stop the cancer from growing or even shrink it. They will be giving the medicine directly into a vein.

This is a 'Phase I/II' study, which means it has two main goals. The first part (Phase I) is about finding the safest dose and understanding any side effects. The second part (Phase II) will then look at how well the medicine works at that chosen dose. Participants might receive AZD9829 on its own or together with other treatments. This kind of research is really important for finding new ways to treat serious diseases like blood cancer.

Key takeaways

  • This study is testing a new medicine (AZD9829) for adults with specific blood cancers.
  • It's for people whose cancer has a 'CD123' marker and hasn't responded to other treatments.
  • The study aims to find a safe dose and see how well the medicine works.
  • You will receive the new medicine directly into a vein.
  • Regular hospital visits for checks and monitoring will be part of the study.

Who may be eligible?

To join this study, you must be 18 years old or older. You need to have a specific type of blood cancer (like certain forms of Leukaemia or Myelodysplastic Syndromes) that has a marker called CD123 on its cells. Importantly, your cancer must have either come back or not responded to at least one previous treatment, and there shouldn't be any other standard treatment options available for you.

You also need to be well enough to take part, meaning you can generally carry out your daily activities without too much difficulty. A doctor will check your overall health and fitness using a standard score to make sure you're suitable.

There are also some reasons why you might not be able to join. For example, if your cancer has spread to your brain or spinal cord, or if you've recently had certain other cancer treatments or stem cell transplants. People with serious ongoing infections or other uncontrolled health issues might also not be able to participate. The medical team will carefully review all your health information to see if this study is right for you.

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. Are you 18 years old or older?
  2. Do you have a specific type of blood cancer that your doctor says has a 'CD123' marker?
  3. Has your cancer come back or not responded to at least one previous treatment?
  4. Are there currently no other standard treatment options available for your cancer?
  5. Are you generally well enough to manage daily activities without major difficulty (your doctor will assess this)?
  6. Have you *not* had your cancer spread to your brain or spinal cord?
Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the new medicine, AZD9829, directly into a vein. The study team will schedule regular visits to the hospital or clinic. These visits will involve blood tests, physical examinations, and other tests to check how you're responding to the treatment and to monitor for any side effects. The frequency of these visits might be more often at the beginning of the study and then become less frequent over time.

You will continue to receive the study treatment for as long as it is helping you and you are tolerating it well. After you stop taking the study medicine, there will be some follow-up visits or phone calls to monitor your health and any lasting effects of the treatment. The total time you might be involved with the study, including follow-up, will vary from person to person.

Potential risks and benefits

Taking part in any clinical study comes with potential benefits and risks. You might benefit from receiving a new treatment that isn't yet widely available, and it could potentially help control your cancer where other treatments haven't. However, like all medicines, AZD9829 could cause side effects, some of which might be serious or unexpected. The study team will explain these in detail and monitor you closely. It's important to remember that you can decide to leave the study at any time, for any reason, without it affecting your future medical care.

Locations (22)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Research Site
    Verified postcode
    Duarte, United States
  • Research Site
    Verified postcode
    St Louis, United States
  • Research Site
    Verified postcode
    New York, United States
  • Research Site
    Verified postcode
    Chapel Hill, United States
  • Research Site
    Verified postcode
    Columbus, United States
  • Research Site
    Verified postcode
    Houston, United States
  • Research Site
    Verified postcode
    Milwaukee, United States
  • Research Site
    Verified postcode
    Heidelberg, Australia
  • Research Site
    Verified postcode
    Melbourne, Australia
  • Research Site
    Verified postcode
    Tianjin, China
  • Research Site
    Verified postcode
    Frankfurt, Germany
  • Research Site
    Verified postcode
    Bologna, Italy

Common questions

What is AZD9829?

AZD9829 is a new medicine being tested for specific blood cancers. It is designed to target a marker called CD123 found on some cancer cells.

What kind of cancers is this study for?

This study is for adults with certain blood cancers (hematological malignancies), like some types of leukaemia, that have a specific marker called CD123.

Why can't I join if I've had certain other treatments?

Some previous treatments might interfere with how AZD9829 works or could increase the risk of side effects, so the study needs to be very careful about who can participate for safety reasons.

Will I get AZD9829 or a placebo (dummy drug)?

Everyone in this study will receive AZD9829. There is no placebo used in this particular trial.

How long will the study last if I join?

The length of your participation can vary. You will receive the treatment as long as it's helping and you're tolerating it well. There will also be follow-up checks after you stop the medicine.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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