NCT05326308

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 Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
705

participants targeted

Target at P75+ for all trials

Timeline
27mo left

Started Apr 2022

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Apr 2022Aug 2028

First Submitted

Initial submission to the registry

March 23, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 13, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

April 26, 2022

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

6.3 years

First QC Date

March 23, 2022

Last Update Submit

September 18, 2025

Conditions

Waldenström's MacroglobulinemiaChronic Lymphocytic LeukemiaMarginal Zone LymphomaFollicular Lymphoma

Keywords

Waldenström's MacroglobulinemiaZanubrutinibBrukinsaChronic Lymphocytic LeukemiaMarginal Zone LymphomaFollicular Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Medical resource utilization

    Frequency of hospitalizations, i.e. number of hospital stays plus number of emergency unit visits (without hospitalization) per patient

    During zanubrutinib treatment, up to 6.3 years

Secondary Outcomes (45)

  • Global health-related quality of life (QoL) collected via EORTC QLQ-C30 during course of treatment and follow-up

    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

    During zanubrutinib treatment and follow-up, up to 6.3 years

  • Incidence of (serious) adverse events ((S)AEs)

    Start of zanubrutinib treatment until 30 days after end of zanubrutinib treatment

  • Incidence of (serious) adverse drug reactions ((S)ADRs)

    Start of zanubrutinib treatment until end of study, up to 6.3 years

  • Incidence of adverse events of special interest (AESIs)

    Start of zanubrutinib treatment until 30 days after end of zanubrutinib treatment

  • +40 more secondary outcomes

Other Outcomes (4)

  • Patients' treatment expectation and satisfaction

    Baseline, 3 months after treatment start with zanubrutinib, end of treatment

  • Physicians' treatment expectation and satisfaction

    Baseline, 3 months after treatment start with zanubrutinib, end of treatment

  • Collection of biomarker test results (according to clinical routine)

    Baseline, up to 6.3 years

  • +1 more other outcomes

Study Arms (4)

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®)

Drug: Zanubrutinib

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®)

Drug: Zanubrutinib

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®)

Drug: Zanubrutinib

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®)

Drug: ZanubrutinibDrug: Obinutuzumab

Interventions

ZanubrutinibDRUG

according to the Summary of Product Characteristics (SmPC).

Also known as: Brukinsa®
Chronic Lymphocytic LeukemiaFollicular LymphomaMarginal Zone LymphomaWaldenström's Macroglobulinemia
ObinutuzumabDRUG

according to the Summary of Product Characteristics (SmPC).

Also known as: Gazyvaro®
Follicular Lymphoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with Waldenström's macroglobulinemia (WM), Chronic Lymphocytic Leukemia (CLL), Marginal Zone Lymphoma (MZL) or Follicular Lymphoma (FL) in need of treatment with decision for treatment with zanubrutinib (Brukinsa®) according to the Summary of Product Characteristics (SmPC).

You may qualify if:

  • 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
  • Age ≥18 years.

You may not qualify if:

  • Contraindications according to SmPC for patients with WM, CLL, MZL or FL
  • Participation in an interventional clinical trial during zanubrutinib treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universitätsklinikum Salzburg, Klinik für Innere Medizin III

Salzburg, A-5020, Austria

RECRUITING

Lübecker Onkologische Schwerpunktpraxis

Lübeck, Schleswig-Holstein, D-23562, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

All patients will be asked to give additional informed consent that their routinely collected biomaterial will be assigned to the decentralized biobank and may be used for future translational research.

MeSH Terms

Conditions

Waldenstrom MacroglobulinemiaLeukemia, Lymphocytic, Chronic, B-CellLymphoma, B-Cell, Marginal ZoneLymphoma, Follicular

Interventions

zanubrutinibobinutuzumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, B-CellLeukemia, LymphoidLeukemiaChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, B-CellLymphoma, Non-HodgkinLymphoma

Study Officials

  • Jens Kisro, Dr.

    Lübecker Onkologische Schwerpunktpraxis

    PRINCIPAL INVESTIGATOR

  • Richard Greil, Prof.

    Universitätsklinikum Salzburg, Klinik für Innere Medizin III

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Kummer, Dr.

CONTACT

+49761152420ariadne@iomedico.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2022

First Posted

April 13, 2022

Study Start

April 26, 2022

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

September 23, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)DE(1)