This clinical trial is focused on studying a type of cancer called lymphoblastic lymphoma, which affects children and adolescents. The trial aims to explore the effectiveness of different treatment approaches to improve outcomes for patients with this disease. The study involves several medications, including prednisone, dexamethasone, PEG-asparaginase, methotrexate, tioguanine, cytarabine, daunorubicin, doxorubicin, ifosfamide, cyclophosphamide, vindesine, vinblastine, and mercaptopurine. These medications are used in various combinations to determine the best treatment strategy.
The purpose of the study is to evaluate whether the risk of cancer returning in the central nervous system can be reduced by using dexamethasone instead of prednisone during the initial phase of treatment. Additionally, for patients at higher risk, the study will test if a more intensive treatment plan can improve the chances of staying cancer-free. This involves additional doses of PEG-asparaginase and a more intense course of treatment with methotrexate and other medications.
Participants in the study will receive treatment over a period of time, with some receiving the standard treatment and others receiving the experimental treatment. The study will monitor the participants to see how well the treatments work and if they help prevent the cancer from coming back. Some participants may receive a placebo as part of the study. The trial is designed to gather important information that could lead to better treatment options for children and adolescents with lymphoblastic lymphoma.
1induction therapy
The initial phase involves the administration of medications to reduce the number of cancer cells. This phase includes the use of prednisone or dexamethasone.
Prednisone is given at a dose of 60 mg per square meter of body surface area per day for 21 days, followed by a 9-day tapering period.
Dexamethasone is administered at a dose of 10 mg per square meter per day for 14 days without tapering.
2protocol Ib
This phase may include additional doses of pegaspargase for patients in the experimental arm.
The aim is to intensify treatment for high-risk patients.
3protocol M
This phase involves a series of treatments for high-risk patients.
It includes one course for high-risk acute lymphoblastic leukemia (HR ALL), followed by a standard high-dose methotrexate course.
Another intense course for HR ALL is administered, followed by a second standard high-dose methotrexate course.
4maintenance therapy
This phase aims to maintain remission and prevent relapse.
Medications such as mercaptopurine and methotrexate are used, typically administered orally.
Who Can Join the Study?
The patient must have a newly diagnosed lymphoblastic lymphoma.
The patient must be under 18 years old at the time of diagnosis.
The patient must be enrolled in a participating center for the study.
There must be a written informed consent from the patient (if they are over 14 years old or as required by local laws) and their parents, agreeing to participate in the trial and allowing the transfer and processing of data.
The patient and the investigator/pathologist must be willing to provide adequate slides or tissue samples for reference pathology and genetic testing, if these samples are available after standard diagnostic procedures.
Who Cannot Join the Study?
Patients who do not have lymphoblastic lymphoma cannot participate. Lymphoblastic lymphoma is a type of cancer that affects the lymphatic system, which is part of the body’s immune system.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not considered part of the specified clinical trial groups cannot participate. This means the study is looking for specific types of patients.
Patients who are not male or female cannot participate. The study is open to both male and female patients.
Patients who are not part of a vulnerable population cannot participate. Vulnerable populations may include groups like children or those with certain health conditions.
Prednisone is a medication used in the trial as part of the standard treatment. It is a type of steroid that helps reduce inflammation and suppress the immune system. In this study, it is used during the induction therapy phase to help decrease the risk of cancer relapse in the central nervous system.
Dexamethasone is another steroid used in the trial, but it is part of the experimental treatment. It is being tested to see if it can more effectively reduce the risk of cancer relapse in the central nervous system compared to prednisone. It also helps reduce inflammation and suppress the immune system.
PEG Asparaginase is an enzyme used in the experimental treatment for high-risk patients. It works by breaking down a nutrient that cancer cells need to grow, thereby helping to stop the cancer from spreading. In this trial, patients receive additional doses to see if it improves treatment outcomes.
Methotrexate is a chemotherapy drug used in the trial. It is given in high doses to help kill cancer cells and prevent them from multiplying. The trial includes both standard and intensified courses of methotrexate to determine the best approach for high-risk patients.
Lymphoblastic Lymphoma – Lymphoblastic lymphoma is a type of non-Hodgkin lymphoma that primarily affects the lymphatic system, which is part of the immune system. It is characterized by the rapid growth of immature white blood cells called lymphoblasts. This disease often presents with swollen lymph nodes, fever, and weight loss. It can progress quickly and may spread to other parts of the body, including the bone marrow and central nervous system. The disease is more common in children and young adults. It is closely related to acute lymphoblastic leukemia, sharing similar cellular characteristics.
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