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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
Date last updated
1/10/2024

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
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.
Trial website
https://clinicaltrials.gov/study/NCT05326308
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05326308