Zanubrutinib in Patients With Waldenström's Macroglobulinemia, Chronic Lymphocytic Leukemia, Marginal Zone Lymphoma and Follicular Lymphoma (ARIADNE)

iOMEDICO

Status: Enrolling

Conditions: Marginal Zone Lymphoma; Follicular Lymphoma; Waldenström's Macroglobulinemia; Chronic Lymphocytic Leukemia

Treatments: Drug: Zanubrutinib; Drug: Obinutuzumab

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05326308

IOM-100461

Details and patient eligibility

About

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.

Full 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.

Enrollment: 705 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

705 participants in 4 patient groups

Waldenström's Macroglobulinemia

Description:

75 patients (excluding screening failures, patients with off-label use or with violation of inclusion/exclusion criteria identified after treatment start) receiving zanubrutinib (Brukinsa®)

Treatment:

Drug: Zanubrutinib

Chronic Lymphocytic Leukemia

Description:

450 patients (excluding screening failures, patients with off-label use or with violation of inclusion/exclusion criteria identified after treatment start) receiving zanubrutinib (Brukinsa®)

Treatment:

Drug: Zanubrutinib

Marginal Zone Lymphoma

Description:

40 patients (excluding screening failures, patients with off-label use or with violation of inclusion/exclusion criteria identified after treatment start) receiving zanubrutinib (Brukinsa®)

Treatment:

Drug: Zanubrutinib

Follicular Lymphoma

Description:

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:

Drug: Obinutuzumab

Drug: Zanubrutinib