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A Study of Blinatumomab in Children with Relapsed or Treatment-Resistant B Cell Acute Lymphoblastic Leukemia with Remaining Disease Traces

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What is this trial about?

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

This study involves children with B-Cell Precursor Acute Lymphoblastic Leukemia, which is a type of blood cancer that affects white blood cells. The study focuses on two specific situations: when the disease has come back after treatment or has not responded to previous treatments (called relapsed or refractory), and when small amounts of cancer cells remain in the body even after treatment (called minimal residual disease positive). The treatment being tested is blinatumomab, which is given as an injection under the skin. This medication works by helping the body's immune system find and attack cancer cells.

The purpose of the study is to test how safe and effective this under-the-skin method of giving blinatumomab is in children under 12 years of age, and to see if it can help eliminate cancer cells from the body. The study is divided into different parts. In the first part, doctors will check if the treatment is safe and well-tolerated in young children. In the second part, doctors will measure how well the treatment works by checking if cancer cells disappear from the bone marrow, which is the spongy tissue inside bones where blood cells are made.

During the study, children will receive the medication in treatment cycles, and doctors will regularly check their blood and bone marrow to see how the disease is responding. The study will also measure the levels of medication in the blood to understand how the body processes it, and will check if the body develops any reaction to the medication. Doctors will monitor for any side effects throughout the treatment period and will track how long any positive response to the treatment lasts.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Treatment initiation and medication administration
The treatment involves receiving blinatumomab, which is a medication given as an injection under the skin. This medication is designed to help the immune system fight leukemia cells.
The treatment is organized into cycles, which are repeated time periods during which the medication is given. The specific dosage and schedule will be determined based on individual circumstances and the phase of the study.
During the first 2 cycles, the medical team will closely monitor the response to treatment. Each cycle typically involves a period of medication administration followed by a break.
Step 2
Regular monitoring and assessments
Throughout the treatment, regular assessments will be conducted to monitor how the body is responding to the medication.
Blood samples will be collected to measure the levels of medication in the bloodstream and to check for any signs of improvement in the condition.
Bone marrow samples may be taken to assess the number of leukemia cells remaining. The goal is to reduce the level of disease to less than 0.01%, which is considered a negative response for minimal residual disease.
The medical team will monitor for any side effects or adverse reactions to the medication throughout the treatment period.
Step 3
Response evaluation after initial cycles
After completing the first 2 cycles of treatment, a comprehensive evaluation will be performed to determine how well the treatment is working.
For participants with relapsed or refractory disease, the evaluation will focus on whether complete remission has been achieved, meaning that leukemia cells are no longer detectable in the bone marrow at significant levels.
For participants with minimal residual disease positive status at the start, the evaluation will assess whether the disease has been reduced to undetectable levels.
The results of these evaluations will help determine the next steps in the treatment plan.
Step 4
Continued treatment cycles
Based on the response to the initial cycles, additional cycles of blinatumomab treatment may be administered.
The duration of continued treatment will depend on individual response and tolerability of the medication.
Throughout all treatment cycles, ongoing monitoring for side effects and treatment effectiveness will continue.
Step 5
Long-term follow-up
After completing the treatment cycles, regular follow-up visits will be scheduled to monitor long-term outcomes.
These visits will include assessments to check whether the disease remains in remission and to monitor overall health status.
The medical team will track the duration of response, which is the length of time from achieving remission until any signs of disease return or until any other significant health event occurs.
Blood tests will be performed to check for the development of antibodies against the medication, which could affect how the body responds to treatment.

Who can join the trial?

8 criteria

The legal guardian or parent must give permission for the child to join the study, and the child must agree to participate according to local rules before any study activities begin.
The child must be between 28 days old and less than 12 years old at the time of joining the study.
The child must have a Lansky Performance Status of at least 50%, which is a measure of how well the child can perform daily activities and take care of themselves.
If the child has received previous treatment targeting CD19 (a protein on certain cancer cells), such as blinatumomab or CAR-T cells (special immune cells modified to fight cancer), they can still join if the cancer cells still show CD19, the treatment ended more than 4 weeks ago, and there were no complications affecting the brain or spinal cord.
Children with Philadelphia chromosome-positive disease (a specific genetic change in the cancer cells) who cannot tolerate or did not respond to previous medicines called tyrosine kinase inhibitors can participate.
For certain study groups: Children whose cancer has come back after treatment or did not respond to any previous treatment, including stem cell transplant (a procedure where healthy blood-forming cells are given to replace diseased ones). Refractory disease means the cancer did not go away with treatment. Relapsed disease means the cancer came back in the blood or bone marrow, or in other parts of the body after it had gone away. Having 5% or more cancer cells in the bone marrow (the soft tissue inside bones where blood cells are made) is considered a relapse.
For certain study groups: Children with minimal residual disease positive (a very small amount of cancer cells still present) must have between 0.1% and less than 5% cancer cells in the bone marrow, and must have blood counts showing at least 500 neutrophils (a type of white blood cell that fights infection) per microliter and at least 50,000 platelets (cells that help blood clot) per microliter, with transfusions allowed if needed.
For certain study groups: A sample of bone marrow from when the cancer was first found or when it came back must be provided for special testing to measure minimal residual disease. In some cases, previous test results may be acceptable instead of a new sample if approved by the study doctor, and permission must be given to use those previous results.

Who cannot join the trial?

3 criteria

The specific exclusion criteria (reasons why a patient cannot participate) have not been provided in the available study information
Generally, clinical trials may exclude patients based on certain health conditions, previous treatments, or other medical factors, but these details are not listed in the current documentation
If you are considering this study, the research team will need to review your complete medical history to determine if you meet all requirements for participation

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Verified sites

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

Assistance Publique Hopitaux De Paris
Verified
Paris, France
Azienda Ospedaliera Santobono Pausilipon
Verified
Naples, Italy
CHRU De Nancy
Responsive
Vandoeuvre Les Nancy, France

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Investigated drugs

Blinatumomab is a medication given as an injection under the skin (subcutaneous injection) that is being tested in this study for children with a type of blood cancer called B-cell acute lymphoblastic leukemia. This medicine works by helping the body's immune system find and attack cancer cells. In this trial, it is being studied to see if it is safe and if it can help treat children whose cancer has come back or has not responded to other treatments, as well as children who still have small amounts of cancer cells remaining in their body.

Blinatumomab

What is already known about the treatment

Blinatumomab – Blinatumomab is a cancer treatment medication given by injection under the skin (subcutaneous administration) that is being studied in children with a specific type of blood cancer called B-cell acute lymphoblastic leukemia, particularly when the disease has come back or hasn't responded to other treatments. This medication works by connecting two types of cells in the body: it acts like a bridge between cancer cells (B-cells) and the body's immune cells (T-cells), helping the immune system recognize and destroy the cancer cells. Blinatumomab belongs to a class of drugs called bispecific T-cell engager antibodies, which are designed to redirect the immune system to fight cancer. This clinical trial is investigating whether giving the medication under the skin is safe and effective in pediatric patients, as this method may be more convenient than the standard intravenous infusion.

Investigated diseases

B-Cell Precursor Acute Lymphoblastic Leukemia – This is a type of blood cancer that affects white blood cells called B-cell lymphocytes in their early stage of development. The disease occurs when the bone marrow produces too many immature white blood 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, patients may experience weakness, frequent infections, easy bruising or bleeding, and bone pain. The condition can be classified as relapsed when it returns after treatment or refractory when it does not respond to treatment. Some patients may have minimal residual disease, which means small amounts of cancer cells remain in the body even after treatment appears successful.