RECRUITING

Observational Study Evaluating the Efficacy and Safety of Zanubrutinib in Participants With Waldenström Macroglobulinemia

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a hybrid (retrospective and prospective) non-interventional registry study to further describe the clinical profile of zanubrutinib in Waldenström macroglobulinemia (WM) participants with and without specific mutations and from racial and ethnic minority groups. Data collected from this registry study will be used to better understand the clinical benefit and safety of zanubrutinib for the treatment of participants in these populations.

Official Title

A Phase 4, Observational Study Evaluating the Efficacy and Safety of the Bruton Tyrosine Kinase (BTK) Inhibitor Zanubrutinib in Patients With Waldenström Macroglobulinemia

Quick Facts

Study Start:2023-03-03
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05640102

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Clinical and definitive histologic diagnosis of WM
  2. * Measurable disease, as defined by a serum immunoglobulin M (IgM) level \> 0.5 g/dL at the time of zanubrutinib initiation
  3. * Started treatment with zanubrutinib, has been treated with zanubrutinib, or is planned to be prescribed zanubrutinib for the treatment of WM
  4. * Bone marrow specimens with central MYD88 test results of:
  5. 1. Cohort 1: MYD88 L265P mutation; enrollment of TN participants will be stopped in each racial and ethnic participant group when the required numbers of participants in the group are met
  6. 2. Cohort 2: non-L265P MYD88 mutation(s) and MYD88WT
  1. * Evidence of disease transformation before the first dose of zanubrutinib
  2. * Evidence of other non-Hodgkin Lymphoma (NHL) subtypes
  3. * Prior or concurrent active malignancy ≤ 2 years before the first dose of zanubrutinib, except for malignancies that, in the investigator's opinion, will not obscure the interpretation of safety or efficacy results
  4. * Concurrent participation in another therapeutic clinical study while receiving zanubrutinib, although the participant may be eligible depending on the status of the interventional study after discussion with the Medical Monitor or designee on an individual basis

Contacts and Locations

Study Contact

Study Director
CONTACT
1-877-828-5568
clinicaltrials@beigene.com

Principal Investigator

Study Director
STUDY_DIRECTOR
BeiGene

Study Locations (Sites)

Clearview Cancer Institute
Huntsville, Alabama, 35805
United States
Mitchell Cancer Institute
Mobile, Alabama, 36604
United States
City of Hope National Medical Center
Duarte, California, 91010
United States
Valkyrie Clinical Trials
Los Angeles, California, 90067
United States
Eisenhower Medical Center, Lucy Curci Cancer Center
Rancho Mirage, California, 92270
United States
Pacific Central Coast Health Centers, Slo Oncology and Hematology Health Center
San Luis Obispo, California, 93401
United States
Pacific Central Coast Health Centers, Mission Hope Medical Oncology
Santa Maria, California, 93454
United States
Brcr Medical Center, Inc
Plantation, Florida, 33322
United States
Tulane Cancer Center
New Orleans, Louisiana, 70112
United States
Hattiesburg Hematology and Oncology Clinic
Hattiesburg, Mississippi, 39401
United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
United States
Summit Medical Group
Florham Park, New Jersey, 07932
United States
Morristown Medical Center
Morristown, New Jersey, 07960
United States
Clinical Research Alliance, Inc
Westbury, New York, 11590
United States

Collaborators and Investigators

Sponsor: BeiGene

  • Study Director, STUDY_DIRECTOR, BeiGene

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-03
Study Completion Date2027-12

Study Record Updates

Study Start Date2023-03-03
Study Completion Date2027-12

Terms related to this study

Additional Relevant MeSH Terms

  • Waldenstrom Macroglobulinemia