Zanubrutinib in Patients With Waldenström's Macroglobulinemia, Chronic Lymphocytic Leukemia, Marginal Zone Lymphoma and Follicular Lymphoma

Frequency of hospitalizations, i.e. number of hospital stays plus number of emergency unit visits (without hospitalization) per patient

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.

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 (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 (S)ADRs related to zanubrutinib

Incidence of AESIs

The time to first onset of AESIs.

The time to first onset of neutropenia grade ≥3 (MedDRA terms: neutropenia and neutrophil count decrease).

Rate of patients with neutropenia grade ≥3 during zanubrutinib treatment. Neutropenia incorporates the MedDRA terms: neutropenia and neutrophil count decrease.

The proportion of patients with a best overall response of CR or VGPR.

MRR is defined as the proportion of patients with a best overall response ≥ PR (partial response)

Best response is defined as best reported response during study treatment CR (complete response) or VGPR (very good partial response).

Change of IgM levels until end of zanubrutinib treatment for WM cohort.

PFS is defined as the time from treatment start until progression or death from any cause, whichever comes first.

Percentage of patients without disease progression or death from any cause at 6, 12, and 24 months after start of zanubrutinib treatment.

OS is defined as the time from treatment start until death.

Percentage of patients alive at 6, 12, and 24 months after start of zanubrutinib treatment.

For the WM cohort, overall response rate is defined as CR, VGPR and PR (partial response).

For the WM cohort, best overall response rate is defined as CR, VGPR, PR (partial response), MR (minor response), SD (stable disease) or PD (progressive disease).

For the CLL cohort, overall response rate is defined as CR and PR.

For the CLL cohort, best overall response rate is defined as CR, PR, SD or PD.

For the MZL cohort, overall response rate is defined as CR, pMRD (probable minimal residue disease), PR and rRD (responding residual disease).

For the MZL cohort, best overall response rate is defined as CR, pMRD, PR, rRD, No change/SD or PD

For the FL cohort, overall response rate is defined as CR or PR.

For the FL cohort, best overall response rate is defined as CR, PR, MR, SD or PD.

TTF is defined as time interval from treatment start to discontinuation of treatment because of disease progression, treatment toxicity, switch of therapy of any reason, and death.

The number of patients receiving blood product transfusion, the number of transfusions per patient and the kind of transfusion (e.g., erythrocytes, thrombocytes).

Difference between the baseline value and the end of treatment value of the IgM level.

Frequency and weighting of distinct parameters affecting therapy choice of the treating physician assessed by project specific questionnaire

Time from first diagnosis of WM, CLL, MZL or FL to zanubrutinib treatment start including timing and duration of possible watch & wait strategy.

Key details of previous therapies (including plasmapheresis for WM, transplantations for WM, CLL and FL, radiotherapy for CLL, MZL and FL and surgery for CLL, MZL and FL).

Frequency tables including the daily dose (mg) will be given using descriptive statistics.

Frequency tables including the daily dose (mg) will be given using descriptive statistics.

Frequency tables will be provided including therapy modifications (reduction and increase) with reasons using descriptive statistics.

Frequency tables will be provided including therapy modifications (reduction and increase) with reasons using descriptive statistics.

Frequency tables will be provided including treatment interruptions with reasons as well as reasons for treatment termination.

Frequency tables will be provided including treatment interruptions with reasons as well as reasons for treatment termination.

Frequency tables will be provided including the dose intensity (absolute and relative) using descriptive statistics.

Frequency tables will be provided including the dose intensity (absolute and relative) using descriptive statistics.

Frequency tables will be provided including the treatment duration will be given using descriptive statistics.

Frequency tables will be provided including the treatment duration will be given using descriptive statistics.

Key details of subsequent antineoplastic therapies after zanubrutinib (including plasmapheresis for WM, stem cell transplantations for WM, CLL and FL, radiotherapy for CLL, MZL and FL and surgery for CLL, MZL and FL): duration (descriptive statistics), number, substances and reason for end of subsequent treatments (frequencies).

Substances (WHO-ATC level 2), ongoing status and indication (frequencies)

Proportion of patients with at least one-time antibiotic use for prophylactic reasons during zanubrutinib treatment.

Proportion of patients taking at least one-time antibiotics for treatment of AEs during zanubrutinib treatment.

Proportion of patients presenting with neutropenia during zanubrutinib treatment taking at least one-time antibiotics.

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 (assessed via project specific questionnaire) will be analyzed by time point, using absolute and relative frequencies.

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.

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.