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.
Austria 
Bulgaria 
Czechia 
Denmark 
Finland 
France 
Germany 
Greece 
Hungary 
Italy 
Norway 
Poland 
Portugal 
Romania 
Spain 
Sweden 
The Netherlands