An observational study of the already approved drug zanubrutinib in the treatment of various blood cancers, to gather more data on the tolerability and safety of the therapy

Waldenström macroglobulinemia (WM), chronic lymphocytic leukemia (CLL), marginal zone lymphoma (MZL), and follicular lymphoma (FL) are different types of lymphomas or leukemias that affect the immune system. These different diseases lead to the uncontrolled proliferation of certain white blood cells, called lymphocytes, which can result in symptoms such as fatigue, susceptibility to infection, and enlarged lymph nodes. The exact causes of these diseases are not fully understood, but genetic factors and immune system disorders play a role. Standard treatment for these diseases varies, but usually includes chemotherapy, immunotherapy, and, increasingly, so-called targeted therapies that target a specific functional mechanism in the affected cells. Zanubrutinib, a Bruton’s tyrosine kinase inhibitor (BTK inhibitor), is a drug that specifically inhibits the activity of an enzyme necessary for the survival and growth of cancer cells. This drug is already approved for the diseases mentioned in the study.

The ARIADNE study is an observational study that collects data under real-world conditions. The study is non-interventional (it does not prescribe any treatment). Patients will be followed for up to 5 years after the start of the study, with a focus on quality of life, the need to seek medical help for treatment-related issues (e.g., hospitalizations), and satisfaction with treatment. Patients are divided into groups based on their diagnosis and treated accordingly.

Eligible participants include women and men aged 18 and older who, depending on their clinical presentation, have not yet received prior treatment or who already require a second or third line of treatment. Patients with Waldenström macroglobulinemia or chronic lymphocytic leukemia may participate in all treatment phases; however, those with marginal zone lymphoma (MZL) or follicular lymphoma (FL) should be in the second (MZL) or third (FL) treatment phase, respectively. For MZL, prior treatment with an anti-CD20 antibody (e.g., rituximab) is also required.