This clinical trial is focused on studying a type of cancer called Diffuse Large B-Cell Lymphoma (DLBCL), specifically a subtype known as non-Germinal Center B-cell (non-GCB) DLBCL. The study is investigating the effectiveness of a treatment combination that includes a medication called Acalabrutinib, also known by its code name ACP-196, along with a group of drugs collectively referred to as R-CHOP. R-CHOP consists of the following medications: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone. The purpose of the study is to determine if adding Acalabrutinib to the R-CHOP regimen can help improve the time patients live without their disease getting worse, compared to using R-CHOP with a placebo.
Participants in the study will be randomly assigned to receive either the combination of Acalabrutinib and R-CHOP or R-CHOP with a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not biased. The treatment will be administered over a period of several months, with regular follow-up visits to monitor the participants’ health and response to the treatment.
The study aims to provide valuable information on whether the addition of Acalabrutinib can enhance the effectiveness of the standard R-CHOP treatment for patients with previously untreated non-GCB DLBCL. By participating in this study, researchers hope to gather data that could lead to improved treatment options for this type of lymphoma in the future.
1initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.
Diagnostic material is forwarded to a central laboratory for gene expression profiling and pathology review.
2treatment phase
The treatment involves a combination of medications administered in cycles. The medications include acalabrutinib, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone.
Acalabrutinib is taken orally in the form of 100 mg hard capsules.
Rituximab, doxorubicin, and vincristine are administered intravenously.
Cyclophosphamide is also administered intravenously.
Prednisone is taken orally.
The treatment cycles are repeated at regular intervals as determined by the study protocol.
3monitoring and follow-up
Regular monitoring is conducted to assess the response to treatment. This includes physical examinations, blood tests, and imaging studies.
Progression-free survival (PFS) is evaluated to determine the effectiveness of the treatment.
Event-free survival (EFS) and overall survival are also assessed as part of the study’s secondary objectives.
4end of study
The study is estimated to conclude by September 3, 2029.
Final assessments are conducted to evaluate the long-term effects and outcomes of the treatment.
Who Can Join the Study?
Men and women aged between 18 and 75 years.
Must have a confirmed diagnosis of Diffuse large B-cell lymphoma (DLBCL). This means the type of cancer has been identified through tests, and there should be enough material from these tests to send to a central lab for further analysis.
No previous treatment for DLBCL.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less. This is a scale used to assess how a disease affects a patient’s daily living abilities, with lower numbers indicating better function.
Have an International Prognostic Index (IPI) score between 1 and 5. This score helps predict the outcome of the disease based on certain factors.
The disease should be at Stage II to IV according to the Ann Arbor Classification. This system is used to describe the extent of cancer spread.
Must have adequate organ and bone marrow function. This means the organs and bone marrow are working well enough to handle the treatment.
Must agree to use highly effective forms of contraception during the study and for 12 months after the last dose of rituximab, a medication used in the study.
Who Cannot Join the Study?
Patients who have already received treatment for their diffuse large B-cell lymphoma cannot participate. This means if you have been treated for this type of cancer before, you are not eligible.
Patients who are younger than 18 years old or older than 75 years old are not eligible to join the study.
Patients who have a different type of lymphoma than the one being studied cannot participate.
Patients who are unable to follow the study procedures or take the study medication as required are not eligible.
Patients who have other serious health conditions that might interfere with the study cannot participate. This means if you have another illness that could affect the study results, you are not eligible.
Patients who are pregnant or breastfeeding are not eligible to join the study.
Patients who have participated in another clinical trial recently may not be eligible. This means if you have been part of another study, you might not be able to join this one.
Patients who have allergies or reactions to the study medications or similar drugs cannot participate.
Acalabrutinib is a medication used in this trial to see if it can help improve the treatment of a type of lymphoma called non-germinal center diffuse large B-cell lymphoma. It is being tested to see if it can work better when added to a standard treatment regimen.
Rituximab is a medication that targets specific cells in the immune system. It is commonly used to treat certain types of lymphoma and is part of the standard treatment regimen in this trial.
Cyclophosphamide is a chemotherapy drug that works by slowing or stopping the growth of cancer cells. It is included in the standard treatment regimen for lymphoma in this trial.
Doxorubicin is another chemotherapy drug used in this trial. It works by interfering with the DNA inside cancer cells, which helps to stop them from growing and dividing.
Vincristine is a chemotherapy medication that helps to stop the growth of cancer cells by interfering with their ability to divide. It is part of the standard treatment regimen in this trial.
Prednisone is a type of steroid that is used to help reduce inflammation and suppress the immune system. In this trial, it is used as part of the standard treatment regimen for lymphoma.
Diffuse 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 rapidly growing tumors in the lymph nodes, spleen, liver, bone marrow, or other organs. The disease can start in any part of the body and may spread to other areas. Symptoms often include swollen lymph nodes, fever, night sweats, and weight loss. The progression of the disease can vary, with some cases advancing quickly. It is the most common type of non-Hodgkin lymphoma in adults.
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