This clinical trial is focused on studying a type of cancer called High-risk Large B-cell Lymphoma. The study aims to compare the effectiveness and safety of a new treatment called Golcadomide when used alongside a standard chemotherapy regimen known as R-CHOP, against a placebo combined with the same chemotherapy. R-CHOP is a combination of drugs that includes Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone. The purpose of the study is to see how well the cancer responds to the treatment and how long patients can live without the disease getting worse.
Participants in the study will receive either the new treatment with Golcadomide or a placebo, along with the R-CHOP chemotherapy. The study will monitor the participants over a period to see how the cancer progresses and to check for any side effects. The main goal is to measure the time it takes for the cancer to worsen or for the patient to pass away, known as Progression-Free Survival (PFS). Other aspects being evaluated include overall survival, which is the time until death from any cause, and whether the cancer completely responds to the treatment.
The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the new treatment or the placebo. This helps ensure the results are unbiased. The trial will continue until 2029, with recruitment starting in 2024. The findings from this study could provide valuable insights into the treatment of High-risk Large B-cell Lymphoma and potentially improve outcomes for patients with this type of cancer.
1joining the study
Upon joining the study, the participant will be randomly assigned to one of two groups: one receiving golcadomide plus R-CHOP chemotherapy, and the other receiving a placebo plus R-CHOP chemotherapy.
The study aims to compare the effectiveness and safety of these treatments in individuals with high-risk large B-cell lymphoma.
2treatment phase
The treatment involves several medications administered in cycles. Each cycle lasts 21 days, and the total number of cycles will be determined by the study protocol.
Medications include rituximab (intravenous), doxorubicin hydrochloride (intravenous), vincristine sulfate (intravenous), cyclophosphamide monohydrate (intravenous), and prednisone (oral).
Participants in the golcadomide group will receive golcadomide capsules orally, while those in the placebo group will receive placebo capsules.
3monitoring and assessments
Throughout the study, regular monitoring and assessments will be conducted to evaluate the participant’s health and response to treatment.
These assessments may include blood tests, imaging studies, and physical examinations to track the progression of the disease and any side effects of the treatment.
4end of treatment evaluation
At the end of the treatment phase, a comprehensive evaluation will be conducted to determine the effectiveness of the treatment.
This evaluation will include checking for complete response to treatment, absence of cancer DNA, and overall survival rates.
5follow-up period
After completing the treatment, participants will enter a follow-up period where their health will continue to be monitored.
The follow-up period is designed to observe long-term outcomes and any late effects of the treatment.
Who Can Join the Study?
You must sign a written informed consent form, which means you agree to participate after understanding the study details.
You should have a specific type of cancer called Large B-cell Lymphoma, which is a type of blood cancer.
You must have a confirmed diagnosis of this cancer, which means it has been checked and verified by a doctor.
Your cancer should not have been treated before.
You need to have a certain score called the IPI score, which helps doctors understand the risk level of your cancer. It should be 1 or 2 with certain conditions, or 3 or higher.
You must have at least one measurable tumor that is larger than 1.5 cm, which is about the size of a grape.
Your ECOG Performance Status, which measures your ability to perform daily activities, should be 0, 1, or 2. A score of 3 is allowed if it is due to the cancer and not other health issues.
Your cancer should be at Ann Arbor Stage II-IV, which indicates the extent of the disease.
Your absolute neutrophil count (a type of white blood cell) should be at least 1.0 x 109/L, and your platelet count should be at least 75 x 109/L, unless affected by the lymphoma.
Your hemoglobin level, which is a measure of red blood cells, should be at least 75 g/L.
Your liver enzymes (AST/SGOT and ALT/SGPT) should be no more than 2.5 times the normal limit, unless the liver is affected by the lymphoma, in which case they should be no more than 5 times the normal limit.
Your serum total bilirubin, a substance made by the liver, should be no more than 1.5 times the normal limit, unless the liver is affected by the lymphoma, in which case it should be no more than 3 times the normal limit. If you have a condition called Gilbert syndrome, it should be no more than 5 times the normal limit.
Your serum creatinine clearance, which measures kidney function, should be at least 45 mL/min, or at least 30 mL/min if the kidneys are affected by the lymphoma.
If you are of childbearing potential, you must agree to receive pregnancy counseling and follow the rules of the Pregnancy Prevention Program.
You must be willing and able to follow the study visit schedule and other study requirements.
You must be between 18 and 80 years old.
Who Cannot Join the Study?
Patients who have a different type of cancer than High-risk Large B-cell Lymphoma 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 groups cannot participate.
Patients who are not willing or able to follow the study procedures cannot participate.
Patients who have other medical conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently may not be eligible.
Patients who have certain allergies or reactions to the study medication cannot participate.
Patients who have a history of certain diseases or conditions that could affect the study results cannot participate.
Patients who are unable to provide informed consent cannot participate.
Golcadomide is a medication being tested in this study to see if it can help treat high-risk large B-cell lymphoma. It is being used in combination with a standard chemotherapy regimen to see if it can improve the time patients live without their cancer getting worse.
R-CHOP Chemotherapy is a combination of drugs commonly used to treat certain types of lymphoma. It includes a mix of medications that work together to kill cancer cells and stop them from growing. In this study, R-CHOP is used as a standard treatment to compare the effects of adding Golcadomide.
High-risk Large B-cell Lymphoma – This is a type of non-Hodgkin lymphoma that originates in the B cells, which are a type of white blood cell. It is characterized by the rapid growth of large cancerous cells in the lymphatic system. The disease can progress quickly, leading to symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. As the lymphoma advances, it may spread to other parts of the body, including the bone marrow, spleen, or liver. The progression of the disease can vary, with some cases remaining localized while others become more widespread.
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