Waldenström's MacroglobulinemiaARIADNENCT05326308
Zanubrutinib in Patients With Waldenström's Macroglobulinemia, Chronic Lymphocytic Leukemia, Marginal Zone Lymphoma and Follicular Lymphoma
An observational study of Waldenström's Macroglobulinemia and Chronic Lymphocytic Leukemia, run by iOMEDICO AG at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Waldenström's Macroglobulinemia, Chronic Lymphocytic Leukemia, Marginal Zone Lymphoma
- What is being tested?
- Zanubrutinib and Obinutuzumab
- How many people
- 845 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 26 Apr 2022to Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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).
Who may be able to join
- 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)
- Signed and dated informed consent form
- Treatment with zanubrutinib according to current SmPC for WM, CLL and MZL
Show all 9Show fewer
- Treatment with zanubrutinib + obinutuzumab for FL according to current SmPC
- Treatment decision before inclusion into this non-interventional study
- Age ≥18 years.
Who cannot join
- Contraindications according to SmPC for patients with WM, CLL, MZL or FL
- Participation in an interventional clinical trial during zanubrutinib treatment.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Austria1 site, 1 recruiting
- Recruiting
Universitätsklinikum Salzburg, Klinik für Innere Medizin III
Salzburg, A-5020
Richard Greil, Prof., +435725525800, r.greil@salk.at
Germany1 site, 1 recruiting
- Recruiting
Lübecker Onkologische Schwerpunktpraxis
Lübeck, Schleswig-Holstein, D-23562
Jens Kisro, Dr., +4945170797226, jens-kisro@t-online.de
About this study
Official title: Zanubrutinib (Brukinsa®) in Patients With Waldenström's Macroglobulinemia (WM), Chronic Lymphocytic Leukemia (CLL), Marginal Zone Lymphoma (MZL) and Follicular Lymphoma (FL) - a Prospective Multicenter Observational Cohort Study
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.
Read the detailed description
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.
- Conditions
- Waldenström's Macroglobulinemia, Chronic Lymphocytic Leukemia, Marginal Zone Lymphoma, Follicular Lymphoma
- Being tested
- Zanubrutinib, Obinutuzumab
- Keywords
- Waldenström's Macroglobulinemia, Zanubrutinib, Brukinsa, Chronic Lymphocytic Leukemia, Marginal Zone Lymphoma, Follicular Lymphoma
- Medical subject headings
- Waldenstrom Macroglobulinemia, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZanubrutinibDrug
Also called Brukinsa®
according to the Summary of Product Characteristics (SmPC).
ObinutuzumabDrug
Also called Gazyvaro®
according to the Summary of Product Characteristics (SmPC).
| Study group | Role | What they receive |
|---|---|---|
| Waldenström's Macroglobulinemia | 75 patients (excluding screening failures, patients with off-label use or with violation of inclusion/exclusion criteria identified after treatment start) receiving zanubrutinib (Brukinsa®) Receives: Drug: Zanubrutinib | |
| Chronic Lymphocytic Leukemia | 690 patients (excluding screening failures, patients with off-label use or with violation of inclusion/exclusion criteria identified after treatment start) receiving zanubrutinib (Brukinsa®) Receives: Drug: Zanubrutinib | |
| Marginal Zone Lymphoma | 40 patients (excluding screening failures, patients with off-label use or with violation of inclusion/exclusion criteria identified after treatment start) receiving zanubrutinib (Brukinsa®) Receives: Drug: Zanubrutinib | |
| Follicular Lymphoma | 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®) Receives: Drug: Zanubrutinib; Drug: Obinutuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical resource utilization
Frequency of hospitalizations, i.e. number of hospital stays plus number of emergency unit visits (without hospitalization) per patient
Measured: During zanubrutinib treatment, up to 6.3 years
Secondary outcomes (45)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Start of zanubrutinib treatment until end of study, up to 6.3 years
Incidence of adverse events of special interest (AESIs)
Incidence of AESIs
Measured: Start of zanubrutinib treatment until 30 days after end of zanubrutinib treatment
Time to AESIs
The time to first onset of AESIs.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6, 12, and 24 months after start of zanubrutinib treatment
Overall Survival (OS)
OS is defined as the time from treatment start until death.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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).
Measured: Baseline
Daily dose of zanubrutinib
Frequency tables including the daily dose (mg) will be given using descriptive statistics.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During zanubrutinib treatment, up to 6.3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start26 Apr 2022
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Waldenström's MacroglobulinemiaStudies of the same condition, open and under way.
- More trials run by iOMEDICO AGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 845 participants (estimated)
Sponsor and investigators
- Lead sponsor
- iOMEDICO AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BeOne Medicines I GmbH
- Responsible party
- Sponsor
- Investigators
- Jens Kisro, Dr., Principal investigator, Lübecker Onkologische SchwerpunktpraxisRichard Greil, Prof., Principal investigator, Universitätsklinikum Salzburg, Klinik für Innere Medizin III
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326308
- Sponsor's protocol ID
- IOM-100461
- Acronym
- ARIADNE
- Status last verified
- Sep 2026
- First submitted
- 23 Mar 2022
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zanubrutinib (Brukinsa®) in Patients With Waldenström's Macroglobulinemia (WM), Chronic Lymphocytic Leukemia (CLL), Marginal Zone Lymphoma (MZL) and Follicular Lymphoma (FL) - a Prospective Multicenter Observational Cohort Study
- ClinicalTrials.gov ID
- NCT05326308
- Acronym / sponsor ID
- ARIADNE / IOM-100461
- Conditions
- Waldenström's Macroglobulinemia, Chronic Lymphocytic Leukemia, Marginal Zone Lymphoma, Follicular Lymphoma
- Keywords
- Waldenström's Macroglobulinemia, Zanubrutinib, Brukinsa, Chronic Lymphocytic Leukemia, Marginal Zone Lymphoma, Follicular Lymphoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 845 participants (estimated)
- Lead sponsor
- iOMEDICO AGIndustry (pharma, biotech, devices)
- Collaborators
- BeOne Medicines I GmbH
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 13 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Waldenström's Macroglobulinemia | – | Drug: Zanubrutinib75 patients (excluding screening failures, patients with off-label use or with violation of inclusion/exclusion criteria identified after treatment start) receiving zanubrutinib (Brukinsa®) |
| Chronic Lymphocytic Leukemia | – | Drug: Zanubrutinib690 patients (excluding screening failures, patients with off-label use or with violation of inclusion/exclusion criteria identified after treatment start) receiving zanubrutinib (Brukinsa®) |
| Marginal Zone Lymphoma | – | Drug: Zanubrutinib40 patients (excluding screening failures, patients with off-label use or with violation of inclusion/exclusion criteria identified after treatment start) receiving zanubrutinib (Brukinsa®) |
| Follicular Lymphoma | – | Drug: Zanubrutinib, Drug: Obinutuzumab40 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®) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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).
Key inclusion criteria (9 listed)
- 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)
- Signed and dated informed consent form
Key exclusion criteria (2 listed)
- Contraindications according to SmPC for patients with WM, CLL, MZL or FL
- Participation in an interventional clinical trial during zanubrutinib treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZanubrutinibAlso: Brukinsa®according to the Summary of Product Characteristics (SmPC). | Drug | Chronic Lymphocytic Leukemia, Follicular Lymphoma, Marginal Zone Lymphoma, Waldenström's Macroglobulinemia |
| ObinutuzumabAlso: Gazyvaro®according to the Summary of Product Characteristics (SmPC). | Drug | Follicular Lymphoma |
Primary outcome
Medical resource utilization
Time frame: During zanubrutinib treatment, up to 6.3 years
Frequency of hospitalizations, i.e. number of hospital stays plus number of emergency unit visits (without hospitalization) per patient
45 secondary outcomes
Global health-related quality of life (QoL) collected via EORTC QLQ-C30 during course of treatment and follow-up
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
Time frame: During zanubrutinib treatment and follow-up, up to 6.3 years
Incidence of (serious) adverse events ((S)AEs)
Time frame: Start of zanubrutinib treatment until 30 days after end of zanubrutinib treatment
Incidence of (serious) adverse drug reactions ((S)ADRs)
Time frame: Start of zanubrutinib treatment until end of study, up to 6.3 years
Incidence of adverse events of special interest (AESIs)
Time frame: Start of zanubrutinib treatment until 30 days after end of zanubrutinib treatment
Time to AESIs
Time frame: Start of zanubrutinib treatment until 30 days after end of zanubrutinib treatment
Time to neutropenia
Time frame: Start of zanubrutinib treatment until 30 days after end of zanubrutinib treatment
Rate of neutropenia grade ≥3
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)
Time frame: During zanubrutinib treatment, up to 6.3 years
In the WM cohort only: Major response rate (MRR)
Time frame: During zanubrutinib treatment, up to 6.3 years
In the WM cohort only: Best response
Time frame: During zanubrutinib treatment, up to 6.3 years
In the WM cohort only: IgM levels
Time frame: During zanubrutinib treatment, up to 6.3 years
Progression-free Survival (PFS)
Time frame: Treatment start with zanubrutinib until end of study, up to 6.3 years
6-, 12-, 18- and 24-month PFS rate
Time frame: 6, 12, and 24 months after start of zanubrutinib treatment
Overall Survival (OS)
Time frame: Treatment start with zanubrutinib until end of study, up to 6.3 years
6-, 12-, 18- and 24-month OS rate
Time frame: 6, 12, and 24 months after start of zanubrutinib treatment
WM Cohort: Overall response rate (ORR)
Time frame: During zanubrutinib treatment, up to 6.3 years
WM Cohort: Best overall response rate (ORR)
Time frame: During zanubrutinib treatment, up to 6.3 years
CLL Cohort: Overall response rate (ORR)
Time frame: During zanubrutinib treatment, up to 6.3 years
CLL Cohort: Best overall response rate (ORR)
Time frame: During zanubrutinib treatment, up to 6.3 years
MZL Cohort: Overall response rate (ORR)
Time frame: During zanubrutinib treatment, up to 6.3 years
MZL Cohort: Best overall response rate (ORR)
Time frame: During zanubrutinib treatment, up to 6.3 years
FL Cohort: Overall response rate (ORR)
Time frame: During zanubrutinib treatment, up to 6.3 years
FL Cohort: Best overall response rate (ORR)
Time frame: During zanubrutinib treatment, up to 6.3 years
Time to treatment failure (TTF)
Time frame: Treatment start with zanubrutinib until end of treatment, up to 6.3 years
Frequency of blood product transfusion
Time frame: During zanubrutinib treatment, up to 6.3 years
WM Cohort: Change of IgM levels until end of zanubrutinib treatment
Time frame: Baseline and end of zanubrutinib treatment, up to 6.3 years
Therapy decision making
Time frame: Baseline
Time from first diagnosis of WM, CLL, MZL or FL to zanubrutinib treatment start
Time frame: Baseline
Previous therapies
Time frame: Baseline
Daily dose of zanubrutinib
Time frame: During zanubrutinib treatment, up to 6.3 years
FL cohort: Daily dose of obinutuzumab
Time frame: During zanubrutinib treatment, up to 6.3 years
Dose modifications of zanubrutinib
Time frame: During zanubrutinib treatment, up to 6.3 years
FL cohort: Dose modifications of obinutuzumab
Time frame: During zanubrutinib treatment, up to 6.3 years
Therapy interruptions of zanubrutinib
Time frame: During zanubrutinib treatment, up to 6.3 years
FL cohort: Therapy interruptions of obinutuzumab
Time frame: During zanubrutinib treatment, up to 6.3 years
Dose intensity of zanubrutinib
Time frame: During zanubrutinib treatment, up to 6.3 years
FL cohort: Dose intensity of obinutuzumab
Time frame: During zanubrutinib treatment, up to 6.3 years
Treatment duration with zanubrutinib
Time frame: During zanubrutinib treatment, up to 6.3 years
FL cohort: Treatment duration with obinutuzumab
Time frame: During zanubrutinib treatment, up to 6.3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Active, not recruitingPhase 4
A Study to Evaluate the Efficacy and Safety of Zanubrutinib in Chinese Adults With Treatment-Naive Waldenström Macroglobulinemia
Waldenström's Macroglobulinemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jens Kisro, Dr. principal investigator
Lübecker Onkologische Schwerpunktpraxis
Richard Greil, Prof. principal investigator
Universitätsklinikum Salzburg, Klinik für Innere Medizin III
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Waldenström's Macroglobulinemia and Chronic Lymphocytic Leukemia, run by iOMEDICO AG at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Kummer, Dr. (+49761152420, ariadne@iomedico.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical resource utilization (time frame: During zanubrutinib treatment, up to 6.3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.