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A Study to Test the Safety and How AZD4512 Works in Patients with Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study involves people with B-cell acute lymphoblastic leukemia, which is a type of blood cancer where the bone marrow makes too many immature white blood cells called lymphoblasts. The study focuses on cases where the disease has either come back after treatment or has not responded to previous treatments. The treatment being tested is AZD4512, which is an experimental medicine given through a vein as an infusion. The medicine is being tested both in people whose disease has a certain genetic marker called Philadelphia chromosome positive and in those without this marker, although later parts of the study will focus only on those without the marker.

The purpose of the study is to find out how safe AZD4512 is, what dose works best, and whether it can help control the leukemia. The study will also look at how the medicine moves through the body, whether the body develops an immune response to it, and how well it works against the cancer. The study is divided into different modules, with the first module testing different doses to find the safest and most effective amount, and the second module testing the chosen dose in more people to better understand how well it works.

During the study, participants will receive AZD4512 through an intravenous infusion, and doctors will closely monitor them for any side effects or changes in their condition. The study will measure whether the cancer responds to treatment by checking if cancer cells in the bone marrow decrease or disappear, and whether any remaining cancer cells can be detected using sensitive testing methods. Participants will have regular check-ups, blood tests, and bone marrow tests to see how the treatment is working and to monitor their overall health throughout the study.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment preparation
Before receiving the first dose of AZD4512, your white blood cell count will be checked. If your peripheral lymphoblast count is 10,000 per microliter or higher, you may receive treatment to reduce these cells first.
The study medication AZD4512 will be administered through intravenous infusion, which means it will be given directly into your vein over a period of time.
Step 2
Treatment phase with AZD4512
You will receive AZD4512 as the main treatment. This medication is given as a solution through an infusion into your vein.
The dose you receive will depend on which part of the study you are enrolled in. In Module 1, different dose levels are being tested to find the safest and most effective amount. In Module 2, specific doses identified in Module 1 will be used.
Your treatment will be organized in cycles. The specific frequency and duration of each infusion will be determined by the study protocol and your response to treatment.
Step 3
Safety monitoring during treatment
Throughout your participation, you will be monitored closely for any side effects or adverse events related to AZD4512.
Regular assessments will be performed to check for any significant changes from your baseline health status.
Blood samples will be collected at specified times to measure how the medication moves through your body, which is called pharmacokinetics.
Your immune system's response to the medication will also be evaluated by checking for anti-drug antibodies, which are proteins your body might produce in response to the treatment.
Step 4
Response evaluation
Your response to treatment will be assessed regularly using established criteria for B-cell acute lymphoblastic leukemia.
Bone marrow samples may be taken to check the percentage of blast cells and determine if you have achieved complete remission, which means no detectable leukemia cells.
Additional testing may be performed to detect minimal residual disease, which refers to very small numbers of cancer cells that may remain after treatment. This is done using a sensitive method called next-generation sequencing.
The assessments will measure various outcomes including overall response rate, time to response, duration of response, and survival.
Step 5
Ongoing treatment cycles
You will continue receiving AZD4512 in repeated cycles as long as the treatment is helping you and you are not experiencing unacceptable side effects.
Your treatment schedule may be adjusted if needed, including dose modifications, delays, or interruptions based on how you tolerate the medication.
If you achieve a good response, you may continue treatment or be considered for stem cell transplantation depending on your individual situation.
Step 6
End of treatment and follow-up
Treatment will be discontinued if your disease progresses, if you experience unacceptable side effects, or for other medical reasons determined by your physician.
After completing treatment with AZD4512, you will be followed to track long-term outcomes including survival and whether you undergo stem cell transplantation.
Follow-up assessments will continue according to the study schedule to monitor your overall health and disease status.

Who can join the trial?

8 criteria

You must be at least 16 years old for Module 1 or at least 12 years old for Module 2
You must have a confirmed diagnosis of B-cell acute lymphoblastic leukemia, which is a type of blood cancer that affects white blood cells
Your leukemia must have either come back after treatment or not responded to treatment, with more than 5 percent of blast cells (immature cancer cells) in your bone marrow (the soft tissue inside bones where blood cells are made) or blast cells appearing again in your peripheral blood (the blood circulating through your body)
Your overall health and ability to perform daily activities must be at an acceptable level, measured by standard scoring systems that assess how well you can care for yourself
The number of lymphoblasts (cancer cells) in your blood must be less than 10,000 per microliter. You may receive treatment to reduce these cells before starting the study if needed
You must have received at least 2 previous treatments that either did not work or stopped working, or you have received 1 previous treatment that failed and have no other standard treatment options available
If you have a specific type called Philadelphia chromosome-positive leukemia (only in Module 1), you must either be unable to tolerate TKI therapy (a type of targeted cancer drug), have medical reasons preventing its use, or your disease has come back or not responded despite treatment with at least 2 prior TKIs or at least one newer generation TKI
Enough time must have passed since your last certain treatments: more than 4 weeks since donor lymphocyte infusion (a treatment using immune cells from a donor), more than 8 weeks since cell therapy or autologous stem cell transplant (transplant using your own cells), and more than 12 weeks since allogeneic stem cell transplant (transplant using donor cells)

Who cannot join the trial?

3 criteria

The study does not list specific exclusion criteria in the provided information, which means the detailed reasons why patients cannot participate are not available in this document.
Generally, clinical trials have exclusion criteria to ensure patient safety and that the study results are accurate, but these specific details would need to be obtained from the complete study documentation.
Patients interested in this study should discuss with their doctor whether they meet all requirements for participation, as there may be additional criteria not shown in this summary.

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Verified sites

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Hospital Universitario De Salamanca
Salamanca, Spain
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Hospital Universitario Hermanos Trias y Pujol. Institut Catalá d'Oncología (ICO)
Badalona, Spain
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Hospital Universitario Marques De Valdecilla
Santander, Spain

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Investigated drugs

AZD4512 is an experimental cancer treatment being tested in this study. It is given to patients with acute lymphoblastic leukemia, which is a type of blood cancer. The medication can be used alone or together with other cancer treatments to see how well it works and how safe it is for patients.

AZD4512

What is already known about the treatment

AZD4512 – AZD4512 is an experimental anticancer medication currently being studied in clinical trials and not yet approved for general medical use. It is being tested as a treatment for B-cell acute lymphoblastic leukemia (B-ALL), a type of blood cancer that affects white blood cells. The medication can be given alone or combined with other cancer-fighting drugs, and researchers are working to determine the safest and most effective dose for patients whose disease has returned or not responded to previous treatments. The exact way AZD4512 works at the cellular level to fight cancer cells is still being investigated as part of ongoing research studies.

Investigated diseases

B-cell acute lymphoblastic leukemia – B-cell acute lymphoblastic leukemia is a type of blood cancer that affects the white blood cells called B-lymphocytes. The disease develops when the bone marrow produces too many immature B-cells that do not function properly. These abnormal cells multiply rapidly and crowd out healthy blood cells in the bone marrow and blood. As the disease progresses, the accumulation of these cancerous cells interferes with the body's ability to produce normal blood cells. This leads to a shortage of healthy red blood cells, white blood cells, and platelets. The condition can advance quickly, affecting various organs as the abnormal cells spread through the bloodstream and lymphatic system.