Not recruitingRare disease

Study on the Safety and Effectiveness of AZD0486 and Tocilizumab for Adolescents and Adults with Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This clinical trial is focused on studying a type of blood cancer called B-cell acute lymphoblastic leukemia (B-ALL). The trial is investigating a new treatment called AZD0486, which is a special kind of medicine known as a human IgG4 kappa monoclonal antibody. This medicine is designed to target specific proteins on cancer cells, known as CD3 and CD19. The study will also involve another medication called tocilizumab, which is already used in other treatments.

The purpose of the study is to determine if AZD0486 is safe and effective for people with B-ALL that has either returned after treatment or has not responded to previous treatments. Participants in the study will receive AZD0486 through an infusion, which means the medicine will be given directly into a vein. The study will be conducted in different parts, with each part focusing on different age groups and specific characteristics of the disease. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of AZD0486.

Throughout the study, participants will be closely monitored to assess how well they tolerate the treatment and to observe any changes in their condition. The study aims to gather information on the safety of AZD0486 and its ability to help control the disease. The trial is expected to continue until the end of 2025, with recruitment starting in 2024. Participants will be involved in regular check-ups and assessments to track their progress and any side effects they may experience.

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
Joining the study
Upon joining the study, eligibility is confirmed based on age and specific medical conditions related to B-cell acute lymphoblastic leukemia.
Participants must have a certain level of disease activity and have undergone previous treatments.
Step 2
Initial assessment
An initial assessment is conducted to evaluate the current health status and disease progression.
This includes laboratory tests and imaging studies to establish a baseline for future comparisons.
Step 3
Treatment administration
The treatment involves the administration of AZD0486, a human monoclonal antibody, through intravenous infusion.
The frequency and dosage are determined by the study protocol and adjusted based on individual response and tolerance.
Step 4
Monitoring and follow-up
Regular monitoring is conducted to assess the safety and effectiveness of the treatment.
This includes frequent medical evaluations, blood tests, and imaging studies to track disease response and any side effects.
Step 5
Additional treatment with tocilizumab
In some cases, tocilizumab may be administered as an additional treatment to manage specific symptoms or side effects.
This is also given intravenously and monitored closely for any adverse reactions.
Step 6
Completion of the study
The study is expected to conclude by the end of 2025, with final assessments to evaluate the overall response to the treatment.
Participants will receive a summary of their treatment outcomes and any necessary follow-up care instructions.

Who can join the trial?

6 criteria

Age requirement: Participants must be between 16 and 80 years old for Part A, and between 12 and 80 years old for Parts B and C.
Participants must have **CD19+ B-cell Acute Lymphoblastic Leukemia**. This means a type of blood cancer that affects certain white blood cells, confirmed by a local lab.
Participants must have more than or equal to 5% **blasts** in their bone marrow. Blasts are immature blood cells.
Participants must have either **relapsed** (cancer has returned) or **refractory** (cancer did not respond to treatment) leukemia after at least two previous treatments, or after one treatment if no standard option is available.
Participants with **Philadelphia positive** leukemia can join Part A if they cannot tolerate or do not respond to **TKIs** (a type of cancer treatment).
Participants must have an **ECOG Performance Status** of 2 or less, or a **Lansky score** of 50% or more. These scores measure how well a person can perform daily activities.

Who cannot join the trial?

8 criteria

Patients who have a different type of cancer other than B-Cell Acute Lymphoblastic Leukaemia cannot participate. This is a specific type of blood cancer.
Patients who are younger than 12 years old or older than 80 years old are not eligible.
Patients who have a condition called Philadelphia chromosome-positive (Ph+) B-ALL in Part B of the study cannot participate. This is a specific genetic change found in some leukemia patients.
Patients who are not able to understand or follow the study procedures will be excluded.
Patients who have any other serious health conditions that might interfere with the study will not be allowed to join.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients who have participated in another clinical trial recently may not be eligible.
Patients who have had a recent infection or illness that could affect the study results will be excluded.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, Italy
Verified
Azienda Ospedaliera Santobono Pausilipon
Naples, Italy
Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain

Trial locations

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Investigated drugs

AZD0486 is an investigational medication being studied for its potential to treat patients with a type of blood cancer known as B-Cell Acute Lymphoblastic Leukemia (B-ALL). This medication is being tested in individuals whose cancer has returned or has not responded to previous treatments. The study aims to determine how safe and tolerable AZD0486 is for patients, as well as how effective it might be in treating this condition. Participants in the trial include both adolescents and adults, ranging in age from 12 to 80 years.

What is already known about the treatment

AZD0486 – AZD0486 is an investigational medication currently being studied in clinical trials for its potential use in treating relapsed or refractory B-Cell Acute Lymphoblastic Leukemia (B-ALL). It is administered to patients in a clinical setting, typically through intravenous infusion. The medication is in the early phases of clinical research, specifically Phase 1/2, where its safety, tolerability, and efficacy are being evaluated. AZD0486 is designed to target specific molecular pathways involved in the growth and survival of cancer cells, aiming to inhibit their proliferation. It falls under the pharmacological classification of targeted cancer therapies, which are developed to interfere with specific molecules necessary for tumor growth and progression.

Investigated diseases

B-Cell Acute Lymphoblastic Leukemia – This is a type of cancer that affects the blood and bone marrow, characterized by the overproduction of immature white blood cells known as lymphoblasts. It primarily involves B-cells, which are a type of white blood cell responsible for producing antibodies. The disease progresses rapidly, leading to an accumulation of these abnormal cells in the bone marrow, which interferes with the production of normal blood cells. This can result in symptoms such as fatigue, frequent infections, and easy bruising or bleeding. The condition is more common in children but can also occur in adults. It is classified as a rare disease and can vary in its genetic characteristics, such as being Philadelphia chromosome positive (Ph+) or negative (Ph-).