An observational study in Waldenström's Macroglobulinemia, Chronic Lymphocytic Leukemia and Marginal Zone Lymphoma, sponsored by iOMEDICO AG. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by iOMEDICO AG · Observational
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.
ARIADNE will collect and analyze data of adult patients with WM, CLL, MZL or FL in need of treatment. The study will explore the medical resource utilization during therapy with zanubrutinib (Brukinsa®). Further aims are to assess effectiveness, safety and tolerability of the treatment as well as treatment satisfaction and biomarkers. These data will be supplemented by the assessment of patient-reported outcomes (PROs)/ health-related quality of life (QoL).
Since treatment options for MW, CLL, MZL or FL are limited and the most important factor is to keep or improve QoL of the patients, there is an urge for real-world clinical data of patients treated with zanubrutinib, especially focusing on patients already treated upfront with a BTK inhibitor, older patients and patients with comorbidities.
524 studies on the registry are indexed under Waldenstrom Macroglobulinemia; 62 are open to participants now.
This study's planned enrollment of 845 is above the median of 150 across 40 observational studies indexed under Waldenstrom Macroglobulinemia.
Browse Waldenstrom Macroglobulinemia studies →iOMEDICO AG is the lead sponsor of 53 studies on the registry; 14 are open to participants now.
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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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
75 patients (excluding screening failures, patients with off-label use or with violation of inclusion/exclusion criteria identified after treatment start) receiving zanubrutinib (Brukinsa®)
Drug: Zanubrutinib
690 patients (excluding screening failures, patients with off-label use or with violation of inclusion/exclusion criteria identified after treatment start) receiving zanubrutinib (Brukinsa®)
Drug: Zanubrutinib
40 patients (excluding screening failures, patients with off-label use or with violation of inclusion/exclusion criteria identified after treatment start) receiving zanubrutinib (Brukinsa®)
Drug: Zanubrutinib
40 patients (excluding screening failures, patients with off-label use or with violation of inclusion/exclusion criteria identified after treatment start) receiving zanubrutinib (Brukinsa®) in combination with obinutuzumab (Gazyvaro®)
Drug: Zanubrutinib · Drug: Obinutuzumab
according to the Summary of Product Characteristics (SmPC).
Also known as: Brukinsa®
according to the Summary of Product Characteristics (SmPC).
Also known as: Gazyvaro®
Medical resource utilization
Frequency of hospitalizations, i.e. number of hospital stays plus number of emergency unit visits (without hospitalization) per patient
Time frame: During zanubrutinib treatment, up to 6.3 years
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.
Time frame: During zanubrutinib treatment and follow-up, up to 6.3 years
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.
Time frame: During zanubrutinib treatment and follow-up, up to 6.3 years
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.
Time frame: Start of zanubrutinib treatment until 30 days after end of zanubrutinib treatment
Incidence of (serious) adverse drug reactions ((S)ADRs)
Incidence of (S)ADRs related to zanubrutinib
Time frame: Start of zanubrutinib treatment until end of study, up to 6.3 years
Incidence of adverse events of special interest (AESIs)
Incidence of AESIs
Time frame: Start of zanubrutinib treatment until 30 days after end of zanubrutinib treatment
Time to AESIs
The time to first onset of AESIs.
Time frame: Start of zanubrutinib treatment until 30 days after end of zanubrutinib treatment
Time to neutropenia
The time to first onset of neutropenia grade ≥3 (MedDRA terms: neutropenia and neutrophil count decrease).
Time frame: Start of zanubrutinib treatment until 30 days after end of zanubrutinib treatment
Rate of neutropenia grade ≥3
Rate of patients with neutropenia grade ≥3 during zanubrutinib treatment. Neutropenia incorporates the MedDRA terms: neutropenia and neutrophil count decrease.
Time frame: Start of zanubrutinib treatment until 30 days after end of zanubrutinib treatment
Proportion of patients with complete response (CR) or very good partial response (VGPR) (best reported response)
The proportion of patients with a best overall response of CR or VGPR.
Time frame: During zanubrutinib treatment, up to 6.3 years
In the WM cohort only: Major response rate (MRR)
MRR is defined as the proportion of patients with a best overall response ≥ PR (partial response)
Time frame: During zanubrutinib treatment, up to 6.3 years
In the WM cohort only: Best response
Best response is defined as best reported response during study treatment CR (complete response) or VGPR (very good partial response).
Time frame: During zanubrutinib treatment, up to 6.3 years
In the WM cohort only: IgM levels
Change of IgM levels until end of zanubrutinib treatment for WM cohort.
Time frame: During zanubrutinib treatment, up to 6.3 years
Progression-free Survival (PFS)
PFS is defined as the time from treatment start until progression or death from any cause, whichever comes first.
Time frame: Treatment start with zanubrutinib until end of study, up to 6.3 years
6-, 12-, 18- and 24-month PFS rate
Percentage of patients without disease progression or death from any cause at 6, 12, and 24 months after start of zanubrutinib treatment.
Time frame: 6, 12, and 24 months after start of zanubrutinib treatment
Overall Survival (OS)
OS is defined as the time from treatment start until death.
Time frame: Treatment start with zanubrutinib until end of study, up to 6.3 years
6-, 12-, 18- and 24-month OS rate
Percentage of patients alive at 6, 12, and 24 months after start of zanubrutinib treatment.
Time frame: 6, 12, and 24 months after start of zanubrutinib treatment
WM Cohort: Overall response rate (ORR)
For the WM cohort, overall response rate is defined as CR, VGPR and PR (partial response).
Time frame: During zanubrutinib treatment, up to 6.3 years
WM Cohort: Best overall response rate (ORR)
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).
Time frame: During zanubrutinib treatment, up to 6.3 years
CLL Cohort: Overall response rate (ORR)
For the CLL cohort, overall response rate is defined as CR and PR.
Time frame: During zanubrutinib treatment, up to 6.3 years
CLL Cohort: Best overall response rate (ORR)
For the CLL cohort, best overall response rate is defined as CR, PR, SD or PD.
Time frame: During zanubrutinib treatment, up to 6.3 years
MZL Cohort: Overall response rate (ORR)
For the MZL cohort, overall response rate is defined as CR, pMRD (probable minimal residue disease), PR and rRD (responding residual disease).
Time frame: During zanubrutinib treatment, up to 6.3 years
MZL Cohort: Best overall response rate (ORR)
For the MZL cohort, best overall response rate is defined as CR, pMRD, PR, rRD, No change/SD or PD
Time frame: During zanubrutinib treatment, up to 6.3 years
FL Cohort: Overall response rate (ORR)
For the FL cohort, overall response rate is defined as CR or PR.
Time frame: During zanubrutinib treatment, up to 6.3 years
FL Cohort: Best overall response rate (ORR)
For the FL cohort, best overall response rate is defined as CR, PR, MR, SD or PD.
Time frame: During zanubrutinib treatment, up to 6.3 years
Time to treatment failure (TTF)
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.
Time frame: Treatment start with zanubrutinib until end of treatment, up to 6.3 years
Frequency of blood product transfusion
The number of patients receiving blood product transfusion, the number of transfusions per patient and the kind of transfusion (e.g., erythrocytes, thrombocytes).
Time frame: During zanubrutinib treatment, up to 6.3 years
WM Cohort: Change of IgM levels until end of zanubrutinib treatment
Difference between the baseline value and the end of treatment value of the IgM level.
Time frame: Baseline and end of zanubrutinib treatment, up to 6.3 years
Therapy decision making
Frequency and weighting of distinct parameters affecting therapy choice of the treating physician assessed by project specific questionnaire
Time frame: Baseline
Time from first diagnosis of WM, CLL, MZL or FL to zanubrutinib treatment start
Time from first diagnosis of WM, CLL, MZL or FL to zanubrutinib treatment start including timing and duration of possible watch \& wait strategy.
Time frame: Baseline
Previous therapies
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).
Time frame: Baseline
Daily dose of zanubrutinib
Frequency tables including the daily dose (mg) will be given using descriptive statistics.
Time frame: During zanubrutinib treatment, up to 6.3 years
FL cohort: Daily dose of obinutuzumab
Frequency tables including the daily dose (mg) will be given using descriptive statistics.
Time frame: During zanubrutinib treatment, up to 6.3 years
Dose modifications of zanubrutinib
Frequency tables will be provided including therapy modifications (reduction and increase) with reasons using descriptive statistics.
Time frame: During zanubrutinib treatment, up to 6.3 years
FL cohort: Dose modifications of obinutuzumab
Frequency tables will be provided including therapy modifications (reduction and increase) with reasons using descriptive statistics.
Time frame: During zanubrutinib treatment, up to 6.3 years
Therapy interruptions of zanubrutinib
Frequency tables will be provided including treatment interruptions with reasons as well as reasons for treatment termination.
Time frame: During zanubrutinib treatment, up to 6.3 years
FL cohort: Therapy interruptions of obinutuzumab
Frequency tables will be provided including treatment interruptions with reasons as well as reasons for treatment termination.
Time frame: During zanubrutinib treatment, up to 6.3 years
Dose intensity of zanubrutinib
Frequency tables will be provided including the dose intensity (absolute and relative) using descriptive statistics.
Time frame: During zanubrutinib treatment, up to 6.3 years
FL cohort: Dose intensity of obinutuzumab
Frequency tables will be provided including the dose intensity (absolute and relative) using descriptive statistics.
Time frame: During zanubrutinib treatment, up to 6.3 years
Treatment duration with zanubrutinib
Frequency tables will be provided including the treatment duration will be given using descriptive statistics.
Time frame: During zanubrutinib treatment, up to 6.3 years
FL cohort: Treatment duration with obinutuzumab
Frequency tables will be provided including the treatment duration will be given using descriptive statistics.
Time frame: During zanubrutinib treatment, up to 6.3 years
Subsequent antineoplastic therapies
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).
Time frame: End of zanubrutinib treatment until end of study, up to 6.3 years
Frequency for concomitant medication during zanubrutinib treatment
Substances (WHO-ATC level 2), ongoing status and indication (frequencies)
Time frame: During zanubrutinib treatment, up to 6.3 years
Frequency of antibiotic use for prophylactic reasons during zanubrutinib treatment
Proportion of patients with at least one-time antibiotic use for prophylactic reasons during zanubrutinib treatment.
Time frame: During zanubrutinib treatment, up to 6.3 years
Frequency of antibiotic use for treatment of AEs during zanubrutinib treatment
Proportion of patients taking at least one-time antibiotics for treatment of AEs during zanubrutinib treatment.
Time frame: During zanubrutinib treatment, up to 6.3 years
Frequency of antibiotic use in patients with neutropenia during zanubrutinib treatment
Proportion of patients presenting with neutropenia during zanubrutinib treatment taking at least one-time antibiotics.
Time frame: During zanubrutinib treatment, up to 6.3 years
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.
Time frame: Baseline, 3 months after treatment start with zanubrutinib, end of treatment
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.
Time frame: Baseline, 3 months after treatment start with zanubrutinib, end of treatment
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.
Time frame: Baseline, up to 6.3 years
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.
Time frame: Baseline and end of zanubrutnib treatment, up to 6.3 years
Plan to share: No
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