The objective of this NIS is to evaluate medical resource utilization, where data is rare in all cohorts, patient's QoL and effectiveness of zanubrutinib treatment in adult patients with WM, CLL, MZL and FL in a real-world setting.
Waldenström's macroglobulinemia (all treatment lines) OR
Chronic lymphocytic leukemia (all treatment lines) OR
Marginal zone lymphoma (≥2 treatment line and at least one anti-CD20 antibody-based previous therapy)
Follicular lymphoma (≥3 treatment line)
Contraindications according to SmPC for patients with WM, CLL, MZL or FL
Participation in an interventional clinical trial during zanubrutinib treatment.
Adult patients with Waldenström's macroglobulinemia (WM), Chronic Lymphocytic Leukemia (CLL), Marginal Zone Lymphoma (MZL) or Follicular Lymphoma (FL) in need of treatment with decision for treatment with zanubrutinib (Brukinsa®) according to the Summary of Product Characteristics (SmPC).
Cohort
Prospective
Zanubrutinib
Drugaccording to the Summary of Product Characteristics (SmPC).
Obinutuzumab
Drugaccording to the Summary of Product Characteristics (SmPC).
Medical resource utilization
Frequency of hospitalizations, i.e. number of hospital stays plus number of emergency unit visits (without hospitalization) per patient
Global health-related quality of life (QoL) collected via EORTC QLQ-C30 during course of treatment and follow-up
Course of QoL during treatment and follow-up (collected via European Organisation for research and treatment of cancer quality of life in cancer patient questionnaire (EORTC QLQ-C30). Scoring of the questionnaire will be performed according to the respective manual.
Global health-related quality of life (QoL) collected via EQ-5D-5L during course of treatment and follow-up
Course of QoL during treatment and follow-up (collected via European quality of life 5 dimension 5 level version (EQ-5D-5L)). Scoring of the questionnaire will be performed according to the respective manual.
Incidence of (serious) adverse events ((S)AEs)
Incidence of (S)AEs; (S)AEs will be summarized by the most recent Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.
Incidence of (serious) adverse drug reactions ((S)ADRs)
Incidence of (S)ADRs related to zanubrutinib
Patients' treatment expectation and satisfaction
Patients' treatment expectation and satisfaction (assessed via project specific questionnaire) will be analyzed by time point, using absolute and relative frequencies.
Physicians' treatment expectation and satisfaction
Physicians' treatment expectation and satisfaction (assessed via project specific questionnaire) will be analyzed by time point, using absolute and relative frequencies.
Collection of biomarker test results (according to clinical routine)
Number of patients with biomarker testing as well as sample types, test methods and test results of biomarker testing per biomarker will be provided including patients with resistance mechanism testing before treatment decision with zanubrutinib. Information on the testing of MYD88 and CXCR4 is mandatory.
Patient management during SARS-Covid-19 pandemic
The patient management during SARS-Covid-19 pandemic (assessed via project specific questionnaire) (patient supervised by oncologist or additionally by family doctor) will be presented by frequency tables.
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iOMEDICO AG
Lead sponsor
BeOne Medicines I GmbH
Collaborator
