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RecruitingPHASE1, PHASE2INTERVENTIONAL

AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia

This research study is looking at a new medicine called AZD0486 for patients, aged 12 and over, who have a type of blood cancer called B-cell Acute Lymphoblastic Leukaemia (B-ALL). This is for people whose cancer has come back or hasn't responded to at least two other treatments. The main goals are to check how safe the medicine is, what side effects it might cause, and to find the most effective dose. Researchers will also look at how well AZD0486 works to treat the cancer. This study is split into different parts to carefully test the medicine step by step, starting with small doses and gradually increasing them to find the best approach.

At a glance

Status
Recruiting
Phase
PHASE1, PHASE2
Sponsor
AstraZeneca
Enrolment target
236
Start
29 Dec 2023
Estimated completion
29 Jun 2027

What is this study about?

This study is a clinical trial, which means it's a careful medical research project testing a new treatment – in this case, a medicine called AZD0486. The aim is to see if this new medicine can help people who have a specific type of blood cancer called B-cell Acute Lymphoblastic Leukaemia (pronounced 'lew-kee-mee-uh'), often shortened to B-ALL.

B-ALL is a cancer of the white blood cells. This study is specifically for patients whose B-ALL has either returned after previous treatments or hasn't responded well to those treatments. Doctors are looking for new options when standard treatments aren't effective enough. AZD0486 is being tested on its own (as a 'monotherapy') to see how well it works.

The study is divided into different stages (Phase 1 and Phase 2). The first stages involve carefully increasing the dose to find one that is both safe and has the best chance of working. Once a good dose is found, more people will receive it to confirm these findings and gather more information. This phased approach helps researchers learn about new medicines safely and effectively.

Key takeaways

  • This study is for people aged 12 and over with B-ALL that has returned or not responded to other treatments.
  • It's testing a new medicine called AZD0486 to check its safety and effectiveness.
  • The study aims to find the best dose of AZD0486.
  • You would be closely monitored for side effects and how the medicine impacts your cancer.
  • Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be at least 12 years old. You must have B-cell Acute Lymphoblastic Leukaemia (B-ALL) where the cancer cells show a specific marker called CD19. Your bone marrow (the spongy tissue inside bones where blood cells are made) must have at least 5% cancer cells.

Importantly, your cancer must have either come back or not responded well after at least two previous treatments. If there are no other standard treatments available, you might still be considered after just one previous treatment. If you have a specific type of B-ALL called Philadelphia positive, you can join if you haven't been able to tolerate or respond to certain other medicines (TKIs).

There are also some reasons why you might not be able to join. For example, if the cancer has spread to your brain or spinal fluid, or if you have certain other serious medical conditions affecting your brain or nervous system. Other reasons include recent severe side effects from past treatments, recent stem cell transplants, or specific types of cancer spread like to the testicles. Your doctor will carefully check all the details to see if this study is suitable 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 12 years old or older?
  2. Do you have B-cell Acute Lymphoblastic Leukaemia (B-ALL) with CD19 on the cancer cells?
  3. Has your B-ALL come back or not responded after at least two previous treatments (or one if no other option)?
  4. Is the cancer not currently active in your brain or spinal fluid?
  5. Have you not had certain other treatments recently, like specific CAR-T cell therapies or stem cell transplants?
  6. Are you generally well enough to participate, as assessed by your doctor?
Answer every question to see your result.

What does participation involve?

This study is looking at a new medicine called AZD0486. Taking part would involve receiving this medicine. Since it's a new treatment being tested, there will be careful monitoring of your health. This will include regular visits to the hospital or clinic for check-ups, blood tests, and other procedures to see how you are responding to the medicine and to check for any side effects. The study has different parts: first, finding the right dose ('dose escalation'), then fine-tuning it ('dose optimisation'), and finally, expanding the study to more people at the best dose ('dose expansion'). The total duration of your participation, and the exact schedule of visits and tests, will be explained in detail by the study team.

Potential risks and benefits

Participating in a clinical trial offers the chance to access a new treatment that isn't widely available, which might help if other treatments haven't worked for your type of B-ALL. While there's potential for benefit, it's also important to understand that this is a new medicine, and doctors are still learning about its effects. This means there could be side effects, some of which might be serious, that aren't fully known yet. You will be closely monitored for any unwanted effects and the study team will explain all known risks. Remember, taking part in any clinical trial is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (80)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Research Site
    Verified postcode
    Birmingham, United States· Withdrawn
  • Research Site
    Verified postcode
    Duarte, United States· Recruiting
  • Research Site
    Verified postcode
    Los Angeles, United States· Recruiting
  • Research Site
    Verified postcode
    Palo Alto, United States· Recruiting
  • Research Site
    Verified postcode
    Tampa, United States· Recruiting
  • Research Site
    Verified postcode
    Atlanta, United States· Recruiting
  • Research Site
    Verified postcode
    Chicago, United States· Recruiting
  • Research Site
    Verified postcode
    New York, United States· Recruiting
  • Research Site
    Verified postcode
    Houston, United States· Recruiting
  • Research Site
    Verified postcode
    Richmond, United States· Recruiting
  • Research Site
    Verified postcode
    Seattle, United States· Withdrawn
  • Research Site
    Verified postcode
    Milwaukee, United States· Recruiting

Common questions

What is B-cell Acute Lymphoblastic Leukaemia (B-ALL)?

B-ALL is a fast-growing cancer of the blood and bone marrow. It affects a specific type of white blood cell called B-lymphocytes.

What does 'monotherapy' mean?

Monotherapy means you would receive only the study medicine, AZD0486, rather than a combination of different treatments.

What are 'relapsed or refractory' cancers?

Relapsed means the cancer has returned after treatment. Refractory means the cancer did not respond to previous treatments.

What does 'CD19 expression' mean?

CD19 is a specific protein found on the surface of B-ALL cancer cells. The study medicine might target cells with this protein.

Will I have to pay to be part of this study?

No, all study-related treatments and tests are provided at no cost if you qualify and choose to participate.

How to find out more

AstraZeneca Clinical Study Information Center

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

Interested in taking part?

Register your interest

Share your details and the research team for "AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaem…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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