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Study on Pegaspargase and Rituximab for Treating Children with 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 clinical trial is focused on studying a type of cancer called Childhood Acute Lymphoblastic Leukemia (ALL), which affects the blood and bone marrow. The study will explore the effectiveness of two treatments: Oncaspar, which contains the active substance pegaspargase, and Riximyo, which contains rituximab. These medications are given through an infusion, which means they are delivered directly into the bloodstream.

The purpose of the study is to find new strategies to improve treatment for children with ALL. The study will look at how well these treatments work in improving survival rates and reducing complications. It will also explore the role of intensified treatment with pegaspargase and the impact of immunotherapy, which is a type of treatment that uses the body's immune system to fight cancer, specifically using rituximab for patients with a subtype of ALL known as B-cell precursor ALL.

Participants in the study will receive either the study medication or a placebo. The study will monitor the participants over a period of time to assess the effectiveness and safety of the treatments. This includes checking for any side effects and measuring how the cancer responds to the treatment. The study aims to provide valuable information that could lead to better treatment options for children with ALL in the future.

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
Enrollment and initial assessment
Upon joining the study, the patient undergoes an initial assessment to confirm eligibility. This includes verifying age, diagnosis of childhood acute lymphoblastic leukemia (ALL), and ensuring informed consent is obtained.
The patient is required to start induction therapy within the specified enrollment period, which is from December 1, 2022, through December 31, 2028.
Step 2
Induction therapy
The induction therapy phase begins immediately after enrollment. This phase aims to reduce the number of leukemia cells in the body.
During this phase, the patient receives medications, including pegaspargase and rituximab, administered through infusion. The specific dosage and frequency are determined by the medical team based on the patient's condition.
Step 3
Monitoring and evaluation
Throughout the trial, the patient's response to treatment is closely monitored. This includes regular blood tests and other assessments to evaluate the effectiveness of the therapy.
On day 33 and day 78, minimal residual disease (MRD) status is checked using a technique called flow cytometry, which helps determine the number of remaining leukemia cells.
Step 4
Intensified treatment
If necessary, the patient may receive intensified treatment with pegaspargase to further target leukemia cells. The decision for intensified treatment is based on the patient's response to initial therapy.
The impact of additional immunotherapy with rituximab is also evaluated for patients with a specific type of ALL known as Bcp-ALL.
Step 5
Follow-up and maintenance
After the main treatment phases, the patient enters a follow-up and maintenance period. This involves regular check-ups to monitor health and ensure the leukemia remains in remission.
During this time, the need for additional treatments, such as immunoglobulin substitution, is assessed based on the patient's immune system status.

Who can join the trial?

6 criteria

Age at diagnosis must be between 1 and less than 18 years old.
Start of the first phase of treatment, called induction therapy, must be within the trial period from December 1, 2022, to December 31, 2028.
Must have a confirmed diagnosis of Acute Lymphoblastic Leukemia (ALL) according to the study's guidelines.
Must have signed an informed consent form to participate in the trial. This means you agree to join the study after understanding all the details.
Must be treated at a medical center that is part of the study.
For female patients who can have children, a urine test for βHCG (a pregnancy test) must be negative.

Who cannot join the trial?

4 criteria

Patients who do not have a diagnosis of Childhood non-mature-B Acute Lymphoblastic Leukemia cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not part of the specified clinical trial group cannot participate.
Patients who are not considered part of the vulnerable population selected for the study cannot participate.

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Verified sites

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

Responsive
KBC Zagreb
Zagreb, Croatia
Responsive
Nosokomeio Paidon I Agia Sofia
Athens, Greece
Responsive
Semmelweis University
Budapest, Hungary

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Investigated drugs

PEG-asparaginase
is a medication used in the treatment of acute lymphoblastic leukemia (ALL). It works by breaking down a substance called asparagine, which is necessary for the growth of cancer cells. By reducing the levels of asparagine, PEG-asparaginase helps to stop the cancer cells from growing and multiplying. This medication is often used as part of a combination of drugs to improve the effectiveness of the treatment.
Anti CD20 immunotherapy
is a type of treatment that targets specific proteins found on the surface of certain cancer cells, particularly in B-cell precursor acute lymphoblastic leukemia (Bcp-ALL). This therapy helps the immune system recognize and attack these cancer cells more effectively. By using the body's own defense mechanisms, anti CD20 immunotherapy aims to reduce the number of cancer cells and improve the chances of remission in patients with this type of leukemia.

What is already known about the treatment

PEG-asparaginase – PEG-asparaginase is administered as an injection, typically given into a muscle or vein. It is currently being studied in clinical trials for its effectiveness in treating childhood non-mature-B Acute Lymphoblastic Leukemia (ALL). The main therapeutic use of PEG-asparaginase is to help improve survival rates and reduce complications in children with ALL. At the molecular level, it works by breaking down asparagine, an amino acid that leukemia cells need to grow, thereby starving the cancer cells. It is classified as an enzyme used in chemotherapy treatments.

Investigated diseases

Childhood 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 begins in the bone marrow, where blood cells are produced, and can quickly spread to the blood and other parts of the body. The disease progresses as these abnormal cells crowd out normal cells, leading to symptoms such as fatigue, fever, and increased risk of infections. As the leukemia cells multiply, they can also spread to the lymph nodes, liver, spleen, and central nervous system. The progression of the disease can vary, but it typically involves phases of rapid growth and periods of remission. The condition is most common in children and requires careful monitoring and management.