Zanubrutinib in Patients With Waldenström's Macroglobulinemia, Chronic Lymphocytic Leukemia, Marginal Zone Lymphoma and Follicular Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Zanubrutinib, Obinutuzumab.
- Who it may be relevant to
- Registry conditions: Waldenström's Macroglobulinemia, Chronic Lymphocytic Leukemia, Marginal Zone Lymphoma, Follicular Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria, Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug Zanubrutinib
according to the Summary of Product Characteristics (SmPC). - Drug Obinutuzumab
according to the Summary of Product Characteristics (SmPC).
Primary outcome measures
- Medical resource utilization [Time frame: During zanubrutinib treatment, up to 6.3 years]
Secondary outcome measures (12)
- 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]
Eligibility criteria
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.
Exclusion criteria
- Contraindications according to SmPC for patients with WM, CLL, MZL or FL
- Participation in an interventional clinical trial during zanubrutinib treatment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Austria · 1 center
- Universitätsklinikum Salzburg, Klinik für Innere Medizin III — Salzburg
Germany · 1 center
- Lübecker Onkologische Schwerpunktpraxis — Lübeck
Identifiers
NCT: NCT05326308 · IOM-100461