Double-blind, randomized, placebo-controlled, prospective Phase III study evaluating efficacy and safety of Panzyga in Primary Infection Prophylaxis in patients with Chronic Lymphocytic Leukemia (“PRO-SID” study)
This study will be performed to determine if Panzyga (the study drug) can help with preventing infections in patients who have chronic lymphocytic leukemia (CLL). The immune system is a bodily system that protects the body from foreign substances, infection agents, cells, and tissues. When the immune system does not work properly, it´s called immunodeficiency. This can be caused by hematological malignancies (forms of cancer that begin in the cells of blood-forming tissue, such as the bone marrow, or in the cells of the immune system) like chronic lymphocytic leukemia (CLL). That´s why patients with CLL are at major risk for severe infections.. Panzyga is a study drug administered via injection into the vein, which contains human antibodies also called immunoglobulins. The study will be conducted at approximately 50 study centers worldwide. In total, at least 256 adult patients will take part in this study.
Are you Eligible? (Inclusion Criteria)
- Are you 18 years of age?
- Do you have diagnosis of Chronic Lymphocytic Leukemia (CLL)?