This clinical trial is focused on studying a type of cancer called anaplastic large cell lymphoma (ALCL), which is a rare form of non-Hodgkin lymphoma. Specifically, the study is looking at cases that are ALK-positive, meaning they have a particular genetic feature that can affect how the cancer grows. The trial is aimed at children and adolescents who have been newly diagnosed with this condition and are considered to have a standard risk level.
The treatment being tested in this study is a medication called Vinblastine Sulfate. This medication is given as an injection into a vein and is known to be a type of drug that interferes with the growth of cancer cells. The purpose of the study is to see if using Vinblastine Sulfate alone for a period of 24 months can effectively treat at least 75% of patients with this type of lymphoma.
Participants in the study will receive Vinblastine Sulfate and will be monitored over time to see how well the treatment works. The study will track the health of participants for at least three years to understand the long-term effects of the treatment. The goal is to determine the likelihood of patients remaining free from cancer-related events, such as the cancer returning or worsening, over a three-year period. This information will help doctors understand if Vinblastine Sulfate is a good treatment option for this type of cancer in young patients.
1initial screening and consent
Upon joining the study, the first step involves confirming eligibility. This includes being diagnosed with ALK-positive anaplastic large cell lymphoma (ALCL) and being under 18 years of age.
Consent from parents or legal guardians is required, along with the child’s agreement if they are capable. This consent covers participation in the study and the handling of personal data.
2pre-treatment procedure
Before starting the main treatment, a procedure called intrathecal triple therapy is administered. This involves the use of three medications: Methotrexate, Cytarabine, and Prednisolone (or Hydrocortisone).
This procedure is done to prepare the body for the main treatment.
3vinblastine treatment
The main treatment involves the administration of Vinblastine sulfate. This medication is given through a vein, a method known as intravenous use.
The treatment with Vinblastine is planned to last for 24 months. The specific dosage and frequency will be determined by the medical team based on individual needs.
4follow-up period
After completing the treatment, a follow-up period of at least 3 years is expected. This is to monitor health and ensure the effectiveness of the treatment.
During this time, regular check-ups and assessments will be conducted to track progress and address any concerns.
Who Can Join the Study?
Must be diagnosed with ALK-positive anaplastic large cell lymphoma (ALCL) and classified as standard risk. This means the disease is in a specific stage: Stage I not completely removed by surgery, or Stage II or III, and must be MDD negative (no minimal disease detected).
Must be younger than 18 years old.
Parents or legal guardians must give their informed consent for the child to participate in the study. If the child is able to understand, they must also agree to participate.
Must participate in the national or study group’s reference pathology, which involves specific medical evaluations.
Must be able to be followed up for at least 3 years after joining the study.
If sexually active, must use a highly effective method of birth control.
Must receive one dose of a specific treatment called intrathecal triple therapy with Methotrexate, Cytarabine, and Prednisolone (or Hydrocortisone) before starting the main treatment in the study. This involves delivering medication directly into the spinal fluid.
Who Cannot Join the Study?
Patients who do not have ALK-positive anaplastic large cell lymphoma (ALCL) cannot participate. ALCL is a type of cancer that affects the lymphatic system, which is part of the immune system.
Patients who are not considered to be at standard risk for this condition cannot participate. Standard risk refers to the usual level of risk associated with the disease.
Patients who are not within the specified age range cannot participate. The age range for this study is not specified here, but it is important for eligibility.
Patients who are not able to follow the treatment plan of Vinblastine-monotherapy for 24 months cannot participate. Vinblastine is a medication used to treat certain types of cancer, and monotherapy means using this medication alone without combining it with other treatments.
Patients who are not able to provide informed consent or who are part of a vulnerable population may not be eligible. Vulnerable populations include groups who may have limited ability to make informed decisions about their participation in the study.
Vinblastine is a medication used in this clinical trial to treat children and adolescents with a specific type of cancer called ALK-positive anaplastic large cell lymphoma (ALCL). This medication works by stopping the growth of cancer cells, which helps to shrink the tumors. In this study, Vinblastine is being tested to see if it can effectively cure at least 75% of patients when used alone over a period of 24 months. The goal is to determine if this treatment can be a successful option for patients with standard risk ALCL.
Anaplastic Large Cell Lymphoma, ALK-Positive – Anaplastic large cell lymphoma (ALCL) is a type of non-Hodgkin lymphoma characterized by the presence of large, abnormal lymphocytes. The ALK-positive variant is identified by the expression of the anaplastic lymphoma kinase (ALK) protein. This disease often begins with painless swelling of lymph nodes, which may be accompanied by fever, weight loss, and night sweats. As it progresses, it can affect various organs, leading to symptoms depending on the areas involved. The disease can spread to other parts of the body, including the skin, bones, and soft tissues. The progression can vary, with some cases remaining localized while others become more widespread.
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