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

Sponsor
iOMEDICO AG
Study ID
NCT05326308
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Zanubrutinib — DRUG
    according to the Summary of Product Characteristics (SmPC).
  • Obinutuzumab — DRUG
    according to the Summary of Product Characteristics (SmPC).

Study Details

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.

Key Dates

First listed
Apr 13, 2022
Start date
Apr 26, 2022
Status verified
Sep 2025
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
705 participants (estimated)

Arms

  • Arm: 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®)
  • Arm: 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®)
  • Arm: 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®)
  • Arm: 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®)

Primary Outcome Measure

Medical resource utilization [ Time Frame: During zanubrutinib treatment, up to 6.3 years ]

Central Contacts

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