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

Sponsor
BeiGene (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05640102
Collaborator
(none)
111
Enrollment
60
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
111 participants
Observational Model:
Cohort
Time Perspective:
Other
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
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2026
Anticipated Study Completion Date :
Dec 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Cohort 1: MYD88 L265P mutation

Arm A: Treatment-naïve (TN); Arm B: Relapsed/refractory (R/R)

Drug: Zanubrutinib
Dosing and treatment duration are at the discretion of the prescribing physician and in accordance with local labeling
Other Names:
  • BGB-3111
  • Brukinsa

    		•
    Cohort 2: Non-L265P MYD88 mutation(s) and MYD88 wildtype

    Arm C: TN and R/R

    Drug: Zanubrutinib
    Dosing and treatment duration are at the discretion of the prescribing physician and in accordance with local labeling
    Other Names:
  • BGB-3111
  • Brukinsa

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Major Response Rate (MRR) [Up to approximately 4 years]

      MRR is defined as the proportion of participants achieving either complete response (CR), very good partial response (VGPR), or partial response (PR) as determined by the investigator using an adaptation of the response criteria updated at the Sixth International Workshop on WM (IWWM)

    Secondary Outcome Measures

    1. VGPR+ Rate [Up to approximately 5 years]

      VGPR+ rate is defined as the proportion of participants achieving either CR or VGPR

    2. Overall Response Rate (ORR) [Up to approximately 5 years]

      ORR is defined as the proportion of participants achieving either CR, VGPR, PR, or minor response (MR)

    3. Duration of Response (DOR) [Up to approximately 5 years]

      DOR is defined as the time from the first determination of response (CR, VGPR, or PR) until first documentation of or death, whichever comes first

    4. Number of Participants with Treatment-emergent Adverse Events [Up to approximately 5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Clinical and definitive histologic diagnosis of WM

    • Measurable disease, as defined by a serum immunoglobulin M (IgM) level > 0.5 g/dL at the time of zanubrutinib initiation

    • Started treatment with zanubrutinib, has been treated with zanubrutinib, or is planned to be prescribed zanubrutinib for the treatment of WM

    • Bone marrow specimens with central MYD88 test results of:

    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

    2. Cohort 2: non-L265P MYD88 mutation(s) and MYD88WT

    Exclusion Criteria:

    • Evidence of disease transformation before the first dose of zanubrutinib

    • Evidence of other non-Hodgkin Lymphoma (NHL) subtypes

    • 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

    • 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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • BeiGene

    Investigators

    • Study Director: Study Director, BeiGene

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    BeiGene
    ClinicalTrials.gov Identifier:
    NCT05640102
    Other Study ID Numbers:
    • BGB-3111-402
    First Posted:
    Dec 7, 2022
    Last Update Posted:
    Dec 7, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Waldenstrom Macroglobulinemia
    Zanubrutinib

    Study Results

    No Results Posted as of Dec 7, 2022