This clinical trial is focused on studying treatments for mature aggressive B-cell lymphoma and leukemia in children and adolescents. These are types of cancers that affect the blood and lymphatic system. The study will explore the effectiveness of various medications, including rituximab, abiraterone acetate, anhydrous cyclophosphamide, cytarabine, vinblastine sulfate, dexamethasone acetate, ifosfamide, methotrexate, etoposide, and vindesine sulfate. These medications are used in different combinations to see how well they work in treating these diseases.
The purpose of the study is to analyze how well patients do without experiencing any events like disease progression or relapse, which is referred to as event-free survival. The study will also look at how the immune system recovers after treatment, particularly focusing on the recovery of a type of white blood cell called CD19+ B-cells. Patients will receive different treatment plans, some including rituximab, to determine if adding this medication improves outcomes.
Participants in the study will receive treatment over a period of time, with some receiving a placebo to compare the effects. The study will monitor patients’ progress and health, aiming to find the most effective treatment plan for these aggressive cancers. The trial will help understand if certain medications can improve survival rates and how they affect the immune system’s recovery.
1initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a series of tests to ensure adequate liver, kidney, and heart function, unless affected by the lymphoma.
2treatment initiation
Treatment begins with the administration of medications. The specific drugs and their administration routes include: prednisolone (intravenous), cyclophosphamide (intravenous), cytarabine (intrathecal and intravenous), vincristine (intravenous), doxorubicin (intravenous), dexamethasone (intravenous), ifosfamide (intravenous), rituximab (intravenous), methotrexate (intrathecal and intravenous), etoposide (intravenous), and vindesine (intravenous).
3treatment cycles
The treatment is structured in cycles, with each cycle involving a combination of the medications listed. The frequency and dosage are determined based on the specific stage of the disease and the treatment protocol.
4monitoring and adjustments
Regular monitoring is conducted to assess the response to treatment. This includes blood tests and imaging studies. Adjustments to the treatment plan may be made based on these results.
5completion of treatment
Upon completion of the treatment cycles, a final assessment is conducted to evaluate the overall response to the therapy. This includes a comprehensive review of the patient’s health status.
6follow-up
Follow-up is expected for at least two years after the initial diagnosis. This involves regular check-ups to monitor for any recurrence of the disease and to assess long-term health outcomes.
Who Can Join the Study?
The patient must have a new diagnosis of an aggressive type of mature B-cell Non-Hodgkin lymphoma, which includes types like Burkitt lymphoma, Burkitt leukemia, diffuse large B-cell lymphoma, or other mature B-cell lymphomas as classified by the World Health Organization (WHO).
There must be available slides or tissue samples for review by a pathology expert, unless the diagnosis is confirmed by specific tests.
The patient must be under 18 years old at the time of diagnosis.
The patient must receive diagnosis and treatment at one of the centers participating in the trial.
The patient must not have received any previous chemotherapy or treatment specifically for lymphoma. Steroids should not have been used for more than two days in the last month.
The patient must have proper liver, kidney, and heart function, unless these issues are caused by the lymphoma itself.
There must be a signed consent form from the patient and/or their parents or guardians agreeing to the treatment plan, participation in the study, and sharing of data.
The patient is expected to be followed up for at least two years after the initial diagnosis.
The patient must have a certificate of vaccination against hepatitis B or a negative test result for hepatitis B, showing no infection.
Who Cannot Join the Study?
Patients who have a different type of cancer than the one being studied.
Patients who are not within the specified age range for the study.
Patients who have other serious health conditions that might interfere with the study.
Patients who are unable to follow the study procedures or attend required visits.
Patients who are pregnant or breastfeeding.
Patients who have received certain treatments recently that could affect the study results.
Patients who have allergies or reactions to the study medications.
Patients who are participating in another clinical trial at the same time.
Patients who have a history of non-compliance with medical treatments.
Patients who have certain infections that could affect the study.
Rituximab is a medication used in this trial to treat children and adolescents with aggressive B-cell lymphoma and leukemia. It is being tested to see if it can improve survival rates when used in different treatment stages. The trial is examining whether using rituximab alone or in combination with standard chemotherapy can help patients live longer without the disease coming back. The study also looks at how the immune system recovers after treatment with rituximab.
Standard Chemotherapy (S-CTX) refers to the usual treatment given to patients with aggressive B-cell lymphoma and leukemia. This therapy involves using a combination of drugs to kill cancer cells and stop them from growing. In this trial, standard chemotherapy is used as a baseline treatment to compare the effects of adding rituximab. The goal is to determine if the addition of rituximab can improve the outcomes for patients.
Mature Aggressive B-cell Lymphoma and Leukemia in Children and Adolescents – This disease involves the rapid growth of B-cells, a type of white blood cell, which can form tumors in lymph nodes or other parts of the body. In children and adolescents, it can manifest as either lymphoma, which primarily affects the lymphatic system, or leukemia, which affects the blood and bone marrow. The disease progresses quickly, often requiring immediate medical attention. It can lead to symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. The aggressive nature of the disease means it can spread rapidly to other organs if not managed promptly.
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