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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05326308




Registration number
NCT05326308
Ethics application status
Date submitted
23/03/2022
Date registered
13/04/2022

Titles & IDs
Public title
Zanubrutinib in Patients With Waldenström's Macroglobulinemia, Chronic Lymphocytic Leukemia, Marginal Zone Lymphoma and Follicular Lymphoma
Scientific 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
Secondary ID [1] 0 0
IOM-100461
Universal Trial Number (UTN)
Trial acronym
ARIADNE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Waldenström's Macroglobulinemia 0 0
Chronic Lymphocytic Leukemia 0 0
Marginal Zone Lymphoma 0 0
Follicular Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Zanubrutinib
Treatment: Drugs - Obinutuzumab

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®)

Chronic Lymphocytic Leukemia - 450 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 - 40 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 - 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®)


Treatment: Drugs: Zanubrutinib
according to the Summary of Product Characteristics (SmPC).

Treatment: Drugs: Obinutuzumab
according to the Summary of Product Characteristics (SmPC).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Medical resource utilization
Timepoint [1] 0 0
During zanubrutinib treatment, up to 6.3 years
Secondary outcome [1] 0 0
Global health-related quality of life (QoL) collected via EORTC QLQ-C30 during course of treatment and follow-up
Timepoint [1] 0 0
During zanubrutinib treatment and follow-up, up to 6.3 years
Secondary outcome [2] 0 0
Global health-related quality of life (QoL) collected via EQ-5D-5L during course of treatment and follow-up
Timepoint [2] 0 0
During zanubrutinib treatment and follow-up, up to 6.3 years
Secondary outcome [3] 0 0
Incidence of (serious) adverse events ((S)AEs)
Timepoint [3] 0 0
Start of zanubrutinib treatment until 30 days after end of zanubrutinib treatment
Secondary outcome [4] 0 0
Incidence of (serious) adverse drug reactions ((S)ADRs)
Timepoint [4] 0 0
Start of zanubrutinib treatment until end of study, up to 6.3 years
Secondary outcome [5] 0 0
Incidence of adverse events of special interest (AESIs)
Timepoint [5] 0 0
Start of zanubrutinib treatment until 30 days after end of zanubrutinib treatment
Secondary outcome [6] 0 0
Time to AESIs
Timepoint [6] 0 0
Start of zanubrutinib treatment until 30 days after end of zanubrutinib treatment
Secondary outcome [7] 0 0
Time to neutropenia
Timepoint [7] 0 0
Start of zanubrutinib treatment until 30 days after end of zanubrutinib treatment
Secondary outcome [8] 0 0
Rate of neutropenia grade =3
Timepoint [8] 0 0
Start of zanubrutinib treatment until 30 days after end of zanubrutinib treatment
Secondary outcome [9] 0 0
Proportion of patients with complete response (CR) or very good partial response (VGPR) (best reported response)
Timepoint [9] 0 0
During zanubrutinib treatment, up to 6.3 years
Secondary outcome [10] 0 0
In the WM cohort only: Major response rate (MRR)
Timepoint [10] 0 0
During zanubrutinib treatment, up to 6.3 years
Secondary outcome [11] 0 0
In the WM cohort only: Best response
Timepoint [11] 0 0
During zanubrutinib treatment, up to 6.3 years
Secondary outcome [12] 0 0
In the WM cohort only: IgM levels
Timepoint [12] 0 0
During zanubrutinib treatment, up to 6.3 years
Secondary outcome [13] 0 0
Progression-free Survival (PFS)
Timepoint [13] 0 0
Treatment start with zanubrutinib until end of study, up to 6.3 years
Secondary outcome [14] 0 0
6-, 12-, 18- and 24-month PFS rate
Timepoint [14] 0 0
6, 12, and 24 months after start of zanubrutinib treatment
Secondary outcome [15] 0 0
Overall Survival (OS)
Timepoint [15] 0 0
Treatment start with zanubrutinib until end of study, up to 6.3 years
Secondary outcome [16] 0 0
6-, 12-, 18- and 24-month OS rate
Timepoint [16] 0 0
6, 12, and 24 months after start of zanubrutinib treatment
Secondary outcome [17] 0 0
WM Cohort: Overall response rate (ORR)
Timepoint [17] 0 0
During zanubrutinib treatment, up to 6.3 years
Secondary outcome [18] 0 0
WM Cohort: Best overall response rate (ORR)
Timepoint [18] 0 0
During zanubrutinib treatment, up to 6.3 years
Secondary outcome [19] 0 0
CLL Cohort: Overall response rate (ORR)
Timepoint [19] 0 0
During zanubrutinib treatment, up to 6.3 years
Secondary outcome [20] 0 0
CLL Cohort: Best overall response rate (ORR)
Timepoint [20] 0 0
During zanubrutinib treatment, up to 6.3 years
Secondary outcome [21] 0 0
MZL Cohort: Overall response rate (ORR)
Timepoint [21] 0 0
During zanubrutinib treatment, up to 6.3 years
Secondary outcome [22] 0 0
MZL Cohort: Best overall response rate (ORR)
Timepoint [22] 0 0
During zanubrutinib treatment, up to 6.3 years
Secondary outcome [23] 0 0
FL Cohort: Overall response rate (ORR)
Timepoint [23] 0 0
During zanubrutinib treatment, up to 6.3 years
Secondary outcome [24] 0 0
FL Cohort: Best overall response rate (ORR)
Timepoint [24] 0 0
During zanubrutinib treatment, up to 6.3 years
Secondary outcome [25] 0 0
Time to treatment failure (TTF)
Timepoint [25] 0 0
Treatment start with zanubrutinib until end of treatment, up to 6.3 years
Secondary outcome [26] 0 0
Frequency of blood product transfusion
Timepoint [26] 0 0
During zanubrutinib treatment, up to 6.3 years
Secondary outcome [27] 0 0
WM Cohort: Change of IgM levels until end of zanubrutinib treatment
Timepoint [27] 0 0
Baseline and end of zanubrutinib treatment, up to 6.3 years
Secondary outcome [28] 0 0
Therapy decision making
Timepoint [28] 0 0
Baseline
Secondary outcome [29] 0 0
Time from first diagnosis of WM, CLL, MZL or FL to zanubrutinib treatment start
Timepoint [29] 0 0
Baseline
Secondary outcome [30] 0 0
Previous therapies
Timepoint [30] 0 0
Baseline
Secondary outcome [31] 0 0
Daily dose of zanubrutinib
Timepoint [31] 0 0
During zanubrutinib treatment, up to 6.3 years
Secondary outcome [32] 0 0
FL cohort: Daily dose of obinutuzumab
Timepoint [32] 0 0
During zanubrutinib treatment, up to 6.3 years
Secondary outcome [33] 0 0
Dose modifications of zanubrutinib
Timepoint [33] 0 0
During zanubrutinib treatment, up to 6.3 years
Secondary outcome [34] 0 0
FL cohort: Dose modifications of obinutuzumab
Timepoint [34] 0 0
During zanubrutinib treatment, up to 6.3 years
Secondary outcome [35] 0 0
Therapy interruptions of zanubrutinib
Timepoint [35] 0 0
During zanubrutinib treatment, up to 6.3 years
Secondary outcome [36] 0 0
FL cohort: Therapy interruptions of obinutuzumab
Timepoint [36] 0 0
During zanubrutinib treatment, up to 6.3 years
Secondary outcome [37] 0 0
Dose intensity of zanubrutinib
Timepoint [37] 0 0
During zanubrutinib treatment, up to 6.3 years
Secondary outcome [38] 0 0
FL cohort: Dose intensity of obinutuzumab
Timepoint [38] 0 0
During zanubrutinib treatment, up to 6.3 years
Secondary outcome [39] 0 0
Treatment duration with zanubrutinib
Timepoint [39] 0 0
During zanubrutinib treatment, up to 6.3 years
Secondary outcome [40] 0 0
FL cohort: Treatment duration with obinutuzumab
Timepoint [40] 0 0
During zanubrutinib treatment, up to 6.3 years
Secondary outcome [41] 0 0
Subsequent antineoplastic therapies
Timepoint [41] 0 0
End of zanubrutinib treatment until end of study, up to 6.3 years
Secondary outcome [42] 0 0
Frequency for concomitant medication during zanubrutinib treatment
Timepoint [42] 0 0
During zanubrutinib treatment, up to 6.3 years
Secondary outcome [43] 0 0
Frequency of antibiotic use for prophylactic reasons during zanubrutinib treatment
Timepoint [43] 0 0
During zanubrutinib treatment, up to 6.3 years
Secondary outcome [44] 0 0
Frequency of antibiotic use for treatment of AEs during zanubrutinib treatment
Timepoint [44] 0 0
During zanubrutinib treatment, up to 6.3 years
Secondary outcome [45] 0 0
Frequency of antibiotic use in patients with neutropenia during zanubrutinib treatment
Timepoint [45] 0 0
During zanubrutinib treatment, up to 6.3 years

Eligibility
Key inclusion criteria
* 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
* Treatment with zanubrutinib + obinutuzumab for FL according to current SmPC
* Treatment decision before inclusion into this non-interventional study
* Age =18 years.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Contraindications according to SmPC for patients with WM, CLL, MZL or FL
* Participation in an interventional clinical trial during zanubrutinib treatment.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2028
Actual
Sample size
Target
605
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Salzburg
Country [2] 0 0
Germany
State/province [2] 0 0
Schleswig-Holstein

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
iOMEDICO AG
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
BeiGene Switzerland GmbH
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jens Kisro, Dr.
Address 0 0
Lübecker Onkologische Schwerpunktpraxis
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Daniel Kummer, Dr.
Address 0 0
Country 0 0
Phone 0 0
+49761152420
Fax 0 0
Email 0 0
ariadne@iomedico.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05326308