This clinical trial is focused on studying the treatment of Advanced Stage Hodgkin Lymphoma, a type of cancer that affects the lymphatic system, which is part of the immune system. The study compares two treatment regimens: one called escalated BEACOPP and another called BrECADD. The BrECADD regimen includes a combination of medications such as Brentuximab Vedotin (also known as SGN-35), Doxorubicin Hydrochloride, Dexamethasone, Cyclophosphamide Monohydrate, Etoposide, and Prednisone. The escalated BEACOPP regimen includes medications like Bleomycin Sulfate, Etoposide Phosphate, Doxorubicin Hydrochloride, Cyclophosphamide Monohydrate, Vincristine Sulfate, Procarbazine Hydrochloride, and Prednisone.
The purpose of the study is to determine if the BrECADD treatment is less toxic than the escalated BEACOPP treatment while maintaining similar effectiveness. Participants will receive either 4 to 6 cycles of the escalated BEACOPP or 4 to 6 cycles of BrECADD, followed by radiotherapy if there are any remaining cancerous areas detected by a PET scan, which is a type of imaging test. The study aims to assess the safety and effectiveness of these treatments in terms of reducing treatment-related side effects and preventing the cancer from worsening.
Throughout the study, participants will be monitored for various outcomes, including how well the cancer responds to treatment, overall survival rates, and any side effects experienced. The study will also look at the quality of life of participants and the occurrence of any new cancers. The trial is designed to provide valuable information on optimizing treatment for patients with advanced Hodgkin Lymphoma, aiming to improve patient outcomes and reduce the burden of treatment side effects.
1initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of classical Hodgkin lymphoma and ensuring no prior treatment has been received.
Eligibility is determined based on the stage of the disease, which should be stage IIB with large mediastinal mass and/or extranodal lesions, stage III, or stage IV. Age criteria are also considered, with participants being between 18 to 75 years old.
2randomization
Participants are randomly assigned to one of two treatment groups: the escalated BEACOPP group or the BrECADD group.
This randomization ensures that each participant has an equal chance of receiving either treatment, which helps in comparing the effectiveness and safety of the two regimens.
3treatment phase
Participants receive 4 to 6 cycles of their assigned treatment. Each cycle involves a combination of medications administered over a specific period.
For the escalated BEACOPP group, medications include doxorubicin hydrochloride, bleomycin sulfate, vincristine sulfate, procarbazine hydrochloride, prednisone, dacarbazine, and cyclophosphamide monohydrate. These are given through intravenous infusion or oral use.
For the BrECADD group, medications include brentuximab vedotin, doxorubicin hydrochloride, dexamethasone, etoposide phosphate, cyclophosphamide monohydrate, and dacarbazine. These are also administered through intravenous infusion or oral use.
4radiotherapy
After completing the chemotherapy cycles, participants with PET-positive residual lesions undergo radiotherapy.
This step aims to target any remaining cancer cells and reduce the risk of disease progression.
5follow-up
Participants enter a follow-up phase where their health and response to treatment are monitored.
The primary focus is on assessing treatment-related side effects, progression-free survival, and overall survival. Additional evaluations include tumor response, quality of life, and any adverse events experienced during the trial.
Who Can Join the Study?
The patient must have a confirmed diagnosis of classical Hodgkin lymphoma. This means that a doctor has checked the type of lymphoma through a biopsy or similar test.
The patient should be newly diagnosed, meaning they have not received any previous treatment for Hodgkin lymphoma.
The patient must be in Stage IIB with a large mass in the chest area or cancer that has spread outside the lymph nodes, or in Stage III or Stage IV. These stages indicate how far the cancer has spread in the body.
For the main part of the study, the patient should be between 18 and 60 years old.
For a specific group of older patients, the age range is between 61 and 75 years old.
Both male and female patients are eligible to participate in the study.
Who Cannot Join the Study?
Patients who have a different type of cancer other than Hodgkin Lymphoma in an advanced stage.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or comply with the study requirements.
Patients who have other serious health conditions that might interfere with the study treatment.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have allergies or reactions to the study medications.
Patients who have a history of substance abuse or alcohol dependency.
Patients who have an active infection that requires treatment.
Patients who have received certain treatments for cancer recently.
Escalated BEACOPP is a combination chemotherapy regimen used to treat advanced stage Hodgkin lymphoma. It includes several drugs that work together to kill cancer cells and stop them from growing. This treatment is known for its effectiveness but can also cause significant side effects.
BrECADD is another combination chemotherapy regimen being studied for the treatment of advanced stage Hodgkin lymphoma. It is designed to be less toxic than escalated BEACOPP while maintaining similar effectiveness. The goal is to reduce the side effects experienced by patients during treatment.
Hodgkin Lymphoma – Hodgkin Lymphoma is a type of cancer that originates in the lymphatic system, which is part of the body’s immune system. It is characterized by the presence of Reed-Sternberg cells, a specific type of abnormal cell. The disease often begins in the lymph nodes and can spread to other parts of the body, including the spleen, liver, and bone marrow. Symptoms may include painless swelling of lymph nodes, fever, night sweats, and weight loss. As the disease progresses, it can affect the body’s ability to fight infections. Advanced stages of Hodgkin Lymphoma may involve more widespread lymph node involvement and additional systemic symptoms.
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